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Minimalaccesssurgery

December 1996

A report of the AustralianHealth Technology

Advisory Committee

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Minimal access

surgery

Australian Health Technology Advisory Committee

Endorsed by the National Health andMedical Research Council December 1996

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© Commonwealth of Australia 1997

ISBN 0 644 39755 1

This work is copyright. Apart from any use as permitted under the Copyright Act 1968 no part may be reproduced by anyprocess without written permission from the Australian Government Publishing Service. Requests and enquiriesconcerning reproduction and rights should be directed to the Manager, Commonwealth Information Service, AustralianGovernment Publishing Service, GPO Box 84, Canberra ACT 2601.

The strategic intent of the National Health and Medical Research Council (NHMRC) is to work with others for the healthof all Australians, by promoting informed debate on ethics and policy, providing knowledge based advice, fostering ahigh quality and internationally recognised research base, and applying research rigour to health issues.

The Australian Health Technology Advisory Committee (AHTAC) is a standing committee of the NHMRC. AHTACevaluates health technologies and highly specialised services looking at the safety, efficacy, effectiveness, cost, equity,access and social impact. AHTAC provides advice on these issues to the NHMRC, the Minister for Health and FamilyServices, the Australian Health Ministers’ Advisory Council, the health profession and the community.

Copies of this report can be obtained from:

The SecretaryAustralian Health Technology Advisory CommitteeDepartment of Health and Family ServicesMail Drop 107GPO Box 9848Canberra ACT 2601

Enquiries about the content of the report should be directed to the above address.

National Health and Medical Research Council documents are prepared by panels of experts drawn from appropriateAustralian academic, professional, community and government organisations. NHMRC is grateful to these people for theexcellent work they do on its behalf. This work is usually performed on an honorary basis and in addition to their usualwork commitments.

Publications Production Unit (Public Affairs, Parliamentary and Access Branch)

Commonwealth Department of Health and Family Services

Publication Number 2042

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ContentsList of tables and figures iv

Executive summary vi

Conclusions and recommendations x

1 Introduction 1Methods 2

2 Laparoscopic inguinal hernia repair 4Methods of hernia repair 4Evaluation of LIHR 7LIHR in Australia 9The case study 11Discussion 22Conclusions 24

3 Laparoscopic assisted hysterectomy 25Methods of hysterectomy 25Evaluation of LAH 27LAH in Australia 29Quality assurance audit 31Discussion 39Conclusions 43

4 Overview 44Conclusions 54

5 Protocol for the assessment of minimal access surgery 55Background 55Issues surrounding the development of a protocol 58Protocol 60

Appendices1 LIHR literature review 632 LAH literature review 843 Terms of reference, committee membership and contributing authors 1054 List of consultation submissions 1085 Acronyms and abbreviations 109

Bibliography1 LIHR 1102 LAH 119

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List of tables and figuresTables2.1 Number of surgeons performing LIHR 132.2 Reasons for not performing LIHR 142.3 Possible expected outcomes of LIHR 142.4 Change of views about LIHR by surgeons surveyed 152.5 Types of clinical audit of LIHR undertaken by surgeons surveyed 152.6 Complications encountered by surgeons performing LIHR 162.7 Rate or severity of complications of LIHR compared to open repair 172.8 Mean number of laparoscopic procedures required annually

to maintain skills 192.9 Waiting times for laparoscopic and open hernia repairs 21

3.1 First unassisted LAH procedure 323.2 Type of LAH performed 333.3 Laparoscopic instruments for major pedicles 333.4 Number of procedures performed by Fellows 353.5 Indications for surgery in patients undergoing LAH 353.6 Histopathology of patients undergoing LAH 363.7 Intra-operative complications in patients undergoing LAH 363.8 Post-operative complications in patients undergoing LAH 363.9 Days of post-operative fever in patients undergoing LAH 373.10 Post-operative use of narcotic analgesia in patients undergoing LAH 373.11 Days in hospital for patients undergoing LAH 373.12 Relief of symptoms in patients undergoing LAH 383.13 Satisfaction with care received and with operation itself 39

A1.1 Multicentre review—MacFadyen et al. (1993) 78A1.2 Multicentre review—Tetik et al. (1994) 79A1.3 Multicentre review—Fitzgibbons et al. (1995) 79A1.4 Summary of randomised trials 80

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A2.1 Classifications for laparoscopic hysterectomy 90A2.2 Published series of laparoscopic hysterectomies 92A2.3 Complication rates for hysterectomy (number/100 cases) 94A2.4 Randomised controlled trials of abdominal versus laparoscopic

hysterectomy 96A2.5 Randomised controlled trials of vaginal versus laparoscopic

hysterectomy 96A2.6 Nonrandomised prospective trials 100A2.7 Retrospective studies—bed stay/costs (days/$) 100A2.8 Subtotal hysterectomy versus LAVH 104

Figures2.1 Number of laparoscopic hernia repairs by State, 1992–1994 102.2 Average length of stay for hernia repair by State, 1992–1994 103.1 Number of laparoscopic hysterectomies by State, 1992–1994 303.2 Average length of stay for hysterectomy by State, 1992–1994 30

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Minimal access surgery

Executive summaryMinimal access surgery has grown rapidly in use and application in Australia,particularly over the last five years, as it promises more rapid recovery, shorterhospital stays and potential cost savings. However, each new laparoscopicprocedure has been introduced and practised widely without initial validationor scientific assessment. It is now apparent that, while some of the proceduresseem to be fulfilling early expectations, others may be associated with newcomplications and adverse outcomes and may not have sufficient advantagesover conventional surgery to make them cost-effective. To assess the intro-duction of laparoscopic surgery into Australian medical practice, the impact oftwo such procedures—laparoscopic inguinal hernia repair (LIHR) and laparo-scopic assisted hysterectomy (LAH)—was assessed using case study andclinical audit methodology.

For both procedures, a literature review was carried out to ascertain the qualityand quantity of the evidence regarding outcomes in comparison with opensurgery, and to identify the risks and benefits of the new procedures. TheAustralian experience was assessed through surveys, site visits and prospectivedata collection.

The case study methodology used in this study provided limited information ofvariable quality, due to varying degrees of cooperation and record keeping atthe hospitals surveyed. The literature reviews in both areas revealed inadequaciesin the size of most of the studies and in the quality of the evidence upon whichto base comparisons of laparoscopic techniques with open surgery.

Laparoscopic inguinal hernia repairLaparoscopic inguinal hernia repair (LIHR) is probably the most controversialof the new procedures. To some surgeons, it is an established procedure withproven benefits, while others suggest that it lacks any advantages over theequivalent conventional procedure.

Fifteen Australian hospitals were surveyed to document early experience withLIHR and current attitudes towards it. The survey included site visits andstructured interviews with medical, nursing and administrative personnelwith particular emphasis placed on training, clinical outcome, institutionalrequirements, instrumentation and attitudes.

There is insufficient evidence about the short and long-term outcomes of LIHRin comparison with open hernia repair. Most data are from uncontrolled, singlecentre studies and the few randomised controlled trials are of inadequate sizeand length of follow-up to allow assessment of important clinical outcomessuch as recurrence and complication rates. There has been little prospectiveaudit of results, and no consistency in the training or credentialling of surgeonswho perform the procedure. LIHR is evolving rapidly and there is no consensusabout the optimal technique, with some techniques being associated with new

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Executive summary

vii

complications and unacceptably high recurrence rates. While LIHR appears tohave advantages over open surgery in terms of length of hospital stay, post-operative pain and time to return to normal activities and work, open surgeryhas been shown to be safe and effective and is also becoming less invasive.

The case study and literature review revealed the following key points.

• While the majority of uncontrolled series published in the surgical literatureare optimistic about the outcome and validity of LIHR, the case study hashighlighted safety and efficacy concerns held by many surgeons.

• Both the case study and the literature review highlight the risk of complica-tions unique to the laparoscopic approach and the lack of current informationavailable to allow the procedure to be seen in a true perspective.

The conclusions of the Australian Health Technology Advisory Committee(AHTAC) relating to LIHR are as follows.

• At present there are insufficient outcome data available to make an informedjudgement on the place of LIHR, given the current state of its application inAustralia.

• In the hands of experienced surgeons, LIHR appears to offer similar short-term outcomes to open repair. The issue of complications and longer termrecurrence remains controversial.

• Laparoscopic surgeons who perform LIHR should enter patients into welldesigned, randomised controlled trials, or at least continually audit allpatient results including long-term follow up.

Laparoscopic assisted hysterectomyLaparoscopic assisted hysterectomy (LAH) is a surgical technique that allowshysterectomy to be performed vaginally in many women who would otherwisehave the more invasive abdominal hysterectomy.

Unlike LIHR, LAH has been introduced gradually and to a limited extent intogynaecological surgery. There are a number of laparoscopic techniques, themain differences between the various surgical approaches being the degree towhich the operation is performed vaginally. Consensus has not been reachedon a classification system and there are many overlapping terms used todescribe various procedures.

An audit of current practice of LAH was carried out by the Royal AustralianCollege of Obstetricians and Gynaecologists (RACOG) through a survey ofFellows of the College and a prospective audit involving a number of Fellowswho practice the new technique. The survey and audit explored a number ofissues including current and planned use of LAH, surgical methodology,training and an assessment of outcome.

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While the available evidence is inadequate to make meaningful comparisonsabout long-term outcomes, initial results show a lower morbidity rate, adecreased time in hospital and more rapid return to normal activity thanfound in abdominal hysterectomy. However, laparoscopic operating times arelonger and the costs greater, especially when disposable instruments are used.

AHTAC’s conclusions relating to LAH are as follows.

• Although introduced without proper initial assessment, LAH has become anaccepted gynaecological procedure with limited utilisation by gynaecologistsin Australia.

• During the learning curve of experience, operative complications have beendocumented in both the literature review and RACOG audit examined inthis LAH case study report. Good quality assurance (QA) practice suggeststhat a further QA study should be encouraged.

• The incidence of complications is not high enough to warrant concern aboutthe safety of LAH in Australia and the overall complication rate is not signifi-cantly different from accepted figures for abdominal and vaginal hysterectomy.

• Patients’ response to this new procedure has been overwhelmingly positive.

Assessment, training and accreditationThe future assessment of new minimally invasive and other surgical technolo-gies will require improved infrastructure for data collection and prospectiveaudit, as well as the funding and utilisation of alternative methodologies suchas prospective randomised trials. To be successful, this must have the coopera-tion and support of the appropriate surgical specialists. Consequently, adequatefunding of an audit office is essential to provide adequate data for future evidencebased decision making and planning in the field of minimal access surgery.Integral to this process is the timely support of well designed and adequatelyresourced multicentre Australian surgical trials. Alternative support mechanismsto the conventional National Health and Medical Research Council (NHMRC)funding process are essential if these trials are to be conducted.

There are a number of major issues associated with the emergence andassessment of new surgical techniques, including:

• the need for comprehensive formal training in the new techniques tominimise the length of the surgeon’s ‘learning curve’;

• credentialling of surgeons to perform new procedures, and the associatedmedicolegal implications;

• the transition of new procedures from being experimental or developmentalto being established surgical practice, and the implications of this forcredentialling of surgeons to perform them; and

• the provision of adequate instrumentation, theatre facilities and trainedstaff to enable new procedures to be thoroughly and accurately assessed.

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Executive summary

ix

AHTAC’s conclusions relating to assessment, training and accreditation are asfollows.

• There is a need for Commonwealth Government funding of prospectiverandomised controlled trials of future endoscopic techniques before theirwidespread acceptance in Australian hospitals.

• Initial assessment of new procedures should be carried out by designatedadvanced endoscopy centres in Australia. The relevant colleges shouldprovide accreditation for these centres to perform this task. These centresmay also be the most appropriate for teaching new techniques and for theutilisation of new technologies.

• Both RACOG/Australian Gynaecological Endoscopy Society (AGES) and theRoyal Australasian College of Surgeons (RACS) endoscopic groups haveintroduced guidelines for training and credentialling. The implementation ofthese guidelines is limited by the need to establish hospital credentiallingcommittees and by unresolved legal problems related to protection of themembers of such committees.

• Since laparoscopic procedures were introduced in Australia, there has beeninadequate provision of theatre facilities, equipment and trained staff apartfrom surgeons. These resources are essential for all units assessing orperforming new procedures.

It is considered that the findings related to the assessment of laparoscopicprocedures could be equally applied to the introduction of other invasiveprocedures, as could the protocol for the evaluation of laparoscopic procedures(see Chapter 5).

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Minimal access surgery

Conclusions & recommendationsIn its terms of reference (Appendix 3), AHTAC was asked to use LIHR andLAH as case studies to consider a number of issues surrounding minimalaccess surgery in Australia. The following conclusions and recommendationsrefer to these general issues, rather than to the case study proceduresthemselves. AHTAC considers that these conclusions and recommendationscould be applied to the introduction of any surgical procedure.

Conclusions• Surgeons, hospitals, governments and the community in general are

concerned that the introduction of minimal access surgery in Australia andelsewhere has occurred without adequate assessment of efficacy and safety.

• Because of the experimental nature of new minimal access procedures,informed consent for patients undergoing such surgery is essential. Theexperimental nature of the procedure, the surgeon’s experience with theprocedure, the lack of long-term outcome data and the potential forcomplications should all be discussed with the patient. As with other clinicaltrial procedures, a patient information sheet approved by an ethicscommittee might be used.

• Data currently available for the assessment of LIHR and its introductioninto Australian surgical practice are inadequate. The true success andcomplication rates for LIHR are unknown, there is limited evidence aboutits efficacy and the cost effectiveness of the procedure has not beenestablished. In contrast, it appears that LAH has become an acceptedgynaecological procedure used by a limited number of gynaecologists, with asafety profile comparable to other forms of hysterectomy.

• The retrospective case study approach to the assessment of new surgicalprocedures is unlikely to yield reliable information that can be used forevaluation purposes. Data collection is retrospective and anecdotal and thismay lead to errors in the assessment of the appropriateness of newtechnologies and procedures. This is evidenced by the information obtainedin this study.

• There is a need for improved prospective audit of new procedures,coordinated and funded through an independent body and supported bysurgical specialists. Outcome reporting, both positive and negative, isessential. The RACS, through its research advisory committee, may be anappropriate body to oversee such an audit and achieve maximumcooperation from practising surgeons. The RACOG already has an activeaudit group collecting such data. Funding will be required to support anaudit office which can reliably perform this role and which is affiliated withthese colleges or other appropriate specialist bodies, in association withhealth authorities.

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Conclusions and recommendations

xi

• Randomised trials are important for the assessment of new surgical techno-logies. However, published trials for LIHR and LAH are inadequate. Improvedfunding support for randomised controlled clinical trials is needed to providedata which will allow adequate assessment of new procedures. The existingmechanisms for the allocation of medical research funding through bodiessuch as the NHMRC are unlikely to provide timely support for thesestudies. Therefore, directly targeted priority funding for the assessment ofnew minimal access or other procedures should be made available.

• A formal and systematic mechanism similar to drug assessment require-ments is required to assess new surgical procedures.

• It appears from the case studies that the current credentialling process isflawed and should be reviewed.

• Both RACOG/AGES and RACS endoscopic groups have introduced guide-lines for training and credentialling. The implementation of these guidelinesis limited by the need to establish hospital credentialling committees and byunresolved legal problems related to protection of the members of suchcommittees.

• The question of medicolegal responsibility of preceptor and trainee remainsa contentious and unresolved issue limiting training by preceptors in manyinstitutions.

• As laparoscopic techniques have been adopted into clinical practice, therehas been no coordinated approach to ensure an appropriate provision of stafftraining, theatre facilities and equipment.

AHTAC recommendations• Recent recommendations for the acquisition of laparoscopic expertise in

policy statements published by RACS and RACOG should be adopted by allthose undertaking laparoscopic surgery. Hospital credentialling committeesshould ensure that surgeons are adequately trained for the procedures theyundertake. These committees will need legislative protection from ‘restraintof trade’ actions if this role is to be fulfilled.

• The introduction of new techniques should be managed in a way that clearlyidentifies whether they are established, or the degree to which they areexperimental or emerging. Evidence based practice is essential for theprotection of surgical patients. This is consistent with AHTAC policyapplying to new technologies.

• A mechanism is needed to ensure that new procedures have been adequatelyassessed (e.g. by centralised audit or trials) and shown to be safe andclinically effective. Cost effectiveness should be evaluated before proceduresare introduced into routine surgical practice.

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• The introduction of such a mechanism will require the urgent provision offinancial support for national audits and trials. Such audits and trials musthave the full support of surgical specialists for accurate and meaningfuloutcomes to be determined. The studies must be carefully designed andconducted and initiated promptly.

• The existing funding mechanisms of the NHMRC are unlikely to providefunding for the necessary trials due to competing research priorities anddelays incurred in the grant assessment process. The Commonwealth/Statesshould allocate a specific research and evaluation budget for the assessmentof new procedures. Research grants should be funded on a competitive basis,meet NHMRC quality criteria and be linked to identified priority questions.

• Specific ongoing funding should be provided for the establishment of auditfacilities by the RACS, RACOG or other appropriate bodies, for the nation-wide assessment of outcomes of new procedures. The cooperation of surgeonsis more likely to be achieved by such bodies.

• New procedures should be regarded as experimental until proven to be safeand efficacious. Funding from private insurance funds and Medicare shouldrecognise this by limiting payment for unestablished procedures to patientsentered by surgeons into the national audit/trial process.

• Medicare item numbers for new procedures should be facilitated, but onlyafter such procedures have been demonstrated to be safe, clinically effectiveand cost-effective.

• Training units accredited by the Colleges should be developed to teach newtechniques and the utilisation of new technologies.

• The current credentialling system should be reviewed. Credentialling ofsurgeons to perform new procedures should be the responsibility ofadequately constituted and protected hospital credentialling committees. Toassist this process, consideration should be given to establishing a set ofnational guidelines, to be applied by these credentialling committees.

• It is envisaged that the Colleges would be the most appropriate bodies toreview the matter of medicolegal responsibility of preceptor and trainee, andto make recommendations to their members about how satisfactory trainingand preceptorship can be achieved.

• In order to adequately assess a new procedure, appropriate staff training,theatre facilities, procedures and equipment must be available to theassessing centres.

CommentDuring the consultation process, the attention of AHTAC was drawn to theexistence of a UK subcommittee which assesses clinical procedures in surgeryand categorises them as established or non-established according to certaincriteria. It may be appropriate to consider the establishment of an expert bodyin Australia to continually assess new surgical techniques before they areaccepted and practised in the general community.

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Introduction

1 IntroductionMinimal access surgery (also called laparoscopic surgery) uses endoscopictechniques to perform surgical procedures less invasively than conventionalopen surgery. An adaptation of a technique used widely for diagnosis, therapeuticlaparoscopic surgery has grown rapidly in use and application as it promises morerapid recovery, shorter hospital stays and potential cost savings. Over the lastfive years, laparoscopic surgery has been adopted widely by surgical specialiststhroughout Australia, with much of the impetus being the apparent dramaticreduction in morbidity following laparoscopic cholecystectomy, as well ascommercial pressures associated with a possible loss of ‘market share’ forsurgeons reluctant or unable to adapt to laparoscopic techniques.

As a result, the majority of Australian general surgeons have retrained inlaparoscopic techniques over a period of two to three years and gynaecologicalsurgeons have extended their skills beyond previous diagnostic, sterilisationand minor therapeutic techniques. Further impetus for change in surgicalpractice has followed the introduction of laparoscopic antireflux surgery,colonic resection, inguinal hernia repair, hysterectomy and many other intra-abdominal and intrathoracic procedures. However, it has also become apparentthat the introduction of this new technology, while promising much, may beassociated with a range of new complications and adverse outcomes, and maynot deliver the potential cost savings to the national health budget which wereoriginally expected.

Each new laparoscopic procedure has been introduced and practised widelywithout initial validation or scientific assessment and with available outcomedata limited usually to uncontrolled personal series, or retrospective com-parisons with equivalent open procedures. A few small randomised trials forlaparoscopic cholecystectomy and laparoscopic inguinal hernia repair havenow been reported, although publication has lagged behind the introduction ofeach procedure by at least three years. This contrasts sharply with the legis-lative requirements for the introduction and evaluation of new medications toAustralia, for which there is a strict assessment process involving testingwithin clinical trials, proof of safety and mechanisms for the reporting of allcomplications to a central body.

In view of growing concern about the most appropriate applications and long-term outcomes of laparoscopic surgery, the Australian Health TechnologyAdvisory Committee (AHTAC) has undertaken an assessment of the intro-duction and impact of two laparoscopic procedures—laparoscopic inguinalhernia repair (LIHR) and laparoscopic assisted hysterectomy (LAH). Theseprocedures were chosen for case studies because of differences in their uptake,acceptance and success.

LIHR is probably the most controversial of the new minimal access procedures.To some surgeons it is an established procedure with proven benefits, whileothers suggest that it lacks any advantages over the equivalent conventional

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Minimal access surgery

2

procedure. On the other hand, LAH has been introduced gradually and to alimited extent into gynaecological surgery, with initial results showing anapparent lower morbidity rate, a decreased time in hospital and more rapidreturn to normal activity compared with abdominal hysterectomy.

The case studies of LIHR and LAH involved hospitals representative of theAustralian health system, in order to examine the impact of the introduction ofnew surgical technologies and to develop recommendations for the assessmentand introduction of new technologies and procedures in the future.

Working Party on Minimal Access SurgeryTo assist AHTAC, a Working Party on Minimal Access Surgery was establishedin 1994. The Working Party was comprised of members with expertise inendoscopic surgery, general surgery, health economics and consumer issues.The membership of AHTAC, the Working Party and its terms of reference areset out in Appendix 3.

The review aimed to use LIHR and LAH as the initial case study procedures to:

• review the scientific literature on them and determine their benefits andrisks;

• consider a number of issues surrounding minimal access surgery, includingtraining requirements, safety considerations and data collection;

• make recommendations about the appropriate application of minimal accesssurgery in Australia; and

• develop a protocol for the assessment of minimal access surgical procedures.

Methods

Case study methodologyCase study methodology is a research tool used to answer broader questionsthan can be addressed by a survey, especially in situations where theinvestigator cannot manipulate conditions. This is done by a variety ofmethods, including literature reviews, direct observation and systematicinterviewing. This methodology was chosen because more information abouteach procedure and its applications was required than could be gathered froma survey. As well as surveys and interviews, literature reviews wereundertaken to identify important information about benefits and risks. Casestudy methodology was also suitable because the study could not be performedunder trial or experimental conditions, both procedures being already wellestablished in Australian hospitals.

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Introduction

3

LIHR case studyFifteen hospitals were surveyed to document early experience with LIHR andcurrent attitudes towards it. Four categories of hospital were also selected forsite visits at which clinical and administrative viewpoints were canvassed fromdifferent perspectives within the hospital system.

LAH clinical auditA prospective quality assurance (QA) survey was undertaken by the RoyalAustralian College of Obstetricians and Gynaecologists (RACOG) and theAustralian Gynaecological Endoscopy Society (AGES). The survey explored anumber of issues including current and planned use of LAH, surgicalmethodology, training and an assessment of outcomes.

Literature reviewsThe literature reviews were based on published articles and commentariesidentified by CD-ROM searches and by review of the references cited in theseprimary sources. International journals in languages other than English weresourced only through their abstracts.

ConsultationThe draft report was released for consultation in September 1996. Copies ofthe report were sent directly to relevant clinician and general practitioner (GP)organisations, allied health organisations, consumer groups and State andTerritory health authorities. In addition, representatives of AHTAC met withmembers of the RACS and RACOG to discuss the draft report. Overall, 17submissions were received. A list of those who made submissions is includedin Appendix 4. Careful consideration was given to the comments received andchanges were made to the report where a consensus could be reached.

The case studies, along with general information and a summary of theliterature, are presented for each procedure in Chapters 2 and 3. The findingsof the studies are related to the terms of reference in Chapter 4, which alsocontains a discussion of the limitations of the methodology and the inadequacyof the evidence in this area. In addition, a protocol was developed for theassessment of minimal access surgical procedures. This is presented inChapter 5. The full literature reviews can be found in Appendices 1 and 2.

Data sourcesThe most recent available data were used. In some cases these are from 1994,but in others the latest available data are from earlier years. AHTAC willcontinue to monitor the data as it becomes available.

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2 Laparoscopic inguinal hernia repair

Inguinal hernia repair is one of the most commonly performed surgical procedures, withover 500 000 patients requiring herniorrhaphy each year in the United States. About41000 open or laparoscopic hernia repair operations are performed each year inAustralia (Hirsch & Hailey 1995).

Laparoscopic herniorrhaphy has attracted widespread interest in Australia, althoughthe uptake of the procedure by general surgeons has been slower than that forlaparoscopic cholecystectomy.

Methods of hernia repair

Conventional Methods of inguinal hernia repair

There are number of different methods for the management of hernial defects.

The traditional operation was originally described in 1887 and has been modified bymany others since. These techniques share the principles of isolation and excision ofthe hernial sac with reconstruction and reinforcement of the posterior wall of theinguinal canal. A large collected review of inguinal hernias repaired by the Bassinimethod and its modifications reported recurrence rates of 1 to 7 per cent for indirecthernias, 4 to 10 per cent for direct hernias and 5 to 35 per cent for recurrent hernias(Condon & Nyhus 1989).

A study of the McVay technique (Cooper's ligament repair) presented the results of 942patients collected over a 25 year period, with a recurrence rate of 1.9 per cent forprimary repairs after an average follow-up of nine years (Rutledge 1988).

The Shouldice hernioplasty was developed in Canada and had evolved to its presentform by 1950. Glassow reported on 12 548 repairs performed at the Shouldice Clinicbetween 1954 and 1974, and cited a recurrence rate of only 1.1 per cent for primaryrepairs (Glassow 1986). The same publication included a summary of seven otherseries all using the same technique with at least a 10-year follow-up, and reported amean recurrence rate of 1.5 per cent from 11809 patients.

Lichtenstein and colleagues in the USA contend that these methods of repair share thecommon disadvantage of tension on the suture line (Lichtenstein et al. 1989) and havepopularised the concept of a tension-free open anterior inguinal hernia repair(Lichtenstein et al. 1989; Shulman et al. 1992a; Amid et al. 1993). In the Lichtensteinrepair, prosthetic mesh is sutured to the inguinal ligament and internal oblique muscle.Using this approach, the usual approximation of aponeurotic tissue under tension isavoided and usually the technique can be performed under local anaesthesia.Impressive results have been published, including low recurrence rates, fewcomplications and early return to regular activity. Recurrence rates of less than 1 per

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cent have been found in several studies (Lichtenstein 1987, Lichtenstein et al. 1989,Shulman et al. 1992b).

The creation of tension, common to many repairs, is felt to be the cause of manyproblems such as post-operative pain and disability. The approach, which modifies theopen preperitoneal approach to hernia repair by using mesh, has gained widespreaduse, particularly for recurrent hernias because it circumvents scar tissue from previoussurgery and for femoral and complicated hernias (e.g. sliding and incarcerated inguinalhernias) because of the greater visibility of the region it affords compared to theanterior approach. Excellent results have been reported, with recurrence rates as lowas 1.4 per cent (Nyhus et al. 1988; Stoppa 1989).

Impressive results with recurrence rates below 1 per cent have been reported fromspecialist centres with open techniques, with and without a prosthesis. However,recurrence rates up to 10 per cent can be expected outside specialist centres (Wantz1984). In England and Wales, 10 per cent of the inguinal hernias repaired annually arefor recurrence and a study of eight Swedish hospitals showed 17 per cent of the herniaoperations were for recurrence (Nilsson et al. 1993). The average recurrence rate isprobably about 10 per cent after primary hernia repair and more than 20 per cent afterrepair of recurrent hernias (Rutkow & Robbins 1993; RACS 1993).

Conventional open herniorrhaphy methods are well established and proven to beeffective, with low morbidity and mortality. Most can be performed under localanaesthetic with or without sedation and patients can go home the same day(Lichtenstein & Shulman 1986), although most open operations in Australia are stillperformed under general anaesthetic. Return to work varies with the amount ofdissection required, the nature of the patient's job, the extent of disability coverage andother factors. However, it may take four to six weeks before full activity can becomfortably resumed after traditional repairs. This extended recovery time andresultant economic impact of millions of days of disability was a major reason for theinitial hope that laparoscopic techniques would reduce post-operative pain and allowearly return to normal activities or work.a

Laparoscopic methods of inguinal hernia repair

The first human laparoscopic herniorrhaphy was performed in 1982 by intra-abdominalstapling of the neck of the sac (Ger 1982). However, there was little interest in thisprocedure until the introduction of laparoscopic cholecystectomy. Bogojavleriskypresented laparoscopic herniorrhaphy to the American Association of GynaecologicalLaparoscopists in 1989 (cited in Cornell & Kerlakian 1994). By 1991, laparoscopicherniorrhaphy was thought to be the 'next revolution in minimal invasive surgery' andenthusiasts predicted that about half all hernia operations would be donelaparoscopically by 1995. However, others predicted that the laparoscopic hernia repairwould be harder to 'sell' because of the variety of techniques employed, in contrast tolaparoscopic cholecystectomy where there is a single approach.

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Methods of LIHR

Laparoscopic hernia repair differs fundamentally from the conventional herniaoperation in that the defect is approached from the posterior aspect, whetherintraperitoneally or retroperitoneally. Although LIHR is soundly based in theory, itspractical application has proved to be difficult. During recent years, numerouslaparoscopic techniques for hernia repair have been introduced. However, some havealready been abandoned by their originators due to unacceptably high complicationand recurrence rates in some centres. As yet there is no consensus about the bestprocedure for laparoscopic hernia repair and three principal methods form the basis ofmost current laparoscopic hernia procedures.

Intraperitoneal onlay mesh technique (IPOM)A large piece of synthetic mesh is placed and fixed directly onto the peritoneumcovering the direct, indirect and femoral hernia spaces. The repair is performed entirelyfrom within the peritoneal cavity.

Transabdominal preperitoneal prosthetic repair (TAPP)This is the most popular current approach. This technique involves laparoscopicaccess to the peritoneal cavity, incision of the peritoneum transversely above thehernia defect to access the preperitoneal plane, and subsequent creation of apreperitoneal space. Synthetic mesh is then placed over the hernial defect in thepreperitoneal plane and secured by sutures or staples. The peritoneal flap isre-approximated over the mesh to create a barrier between the mesh and the bowel(Nguyen et al. 1994).

Total extraperitoneal approach (TEP)This technique avoids entrance into the abdominal cavity by using the space betweenthe peritoneum and the transversalis fascia to access the inguinal region (Nguyen et al.1994). A small incision is made below the umbilicus and a preperitoneal space createdby tunnelling, either using blunt instruments, aquadissection or a balloon dissectiondevice. The indirect hernial sac is excised and a large piece of polypropylene mesh isplaced over the defect and fixed with staples. This approach is said to combine theadvantages of the open preperitoneal technique with those of minimal access surgery.More detailed accounts of each technique can be found in a review by Hanafy (1993).Long-term results for the various laparoscopic methods are not yet available, withseveral authors compiling series as the data become available. The longest publishedfollow-up periods are presently less than two years. Reported recurrence rates are 0.6to 0.8 per cent for transabdominal preperitoneal repair and 3.2 per cent forintraperitoneal onlay mesh repair, although these are likely to be underestimations dueto the limited follow-up.

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Evaluation of LIHR

Many surgeons advocate the benefits of LIHR, while others suggest that itlacks any advantages over the equivalent conventional procedure. Before ameaningful comparison can be made between open and laparoscopic herniarepair, a 'gold standard' must be determined for both. This is difficult because,as discussed above, there is little agreement among surgeons about theoptimal technique for either procedure.

• For open repairs, the Lichtenstein (mesh) repair, the Shouldice repair and atension-free darn have all been proposed as the gold standard.

• There is no standardised laparoscopic technique, which complicates both theevaluation of the technique and comparison of the available evidence.

The fact that open procedures can now be performed under local anaesthesia usingthe facilities of a day surgery unit is important in the evaluation of LIHR. To date, nearlyall LIHR procedures have required general anaesthesia, with most requiring inpatientcare. This may have adverse cost implications for hospital funding of LIHR. Asoutcomes such as morbidity and recurrence rates are acceptable with the opentechnique, LIHR must demonstrate equal or superior results for these outcomes as wellas advantages for other outcomes such as length of hospital stay and return to usualactivity. As the differences between the outcomes and costs of the two techniqueslessen, it is becoming increasingly important to have sound evidence upon which tobase comparisons and assess efficacy.

Summary of the literatureA literature review was undertaken by the study group, based on published articles andcommentaries identified by a search of the databases Medline and Healthplan usingthe terms laparoscopic surgery and hernia, and by review of the references cited inthese primary sources. The full literature review is presented in Appendix 1.

An assessment of the literature highlights the inadequacy of the published articles inthis area, with only four small randomised controlled trials, three multicentre reviewsand a number of non-randomised single group studies.

The randomised controlled trials comparing laparoscopic and open hernia repair all haddesign limitations. The sample sizes used for each study failed to include an adequatenumber of patients to determine statistically significant differences between theimportant clinical outcomes for each group.

Recurrence and complication ratesOn the basis of the available evidence, it is difficult to compare recurrence andMPlication rates between the open and laparoscopic techniques because of the size ofthe studies and the length of the follow-up. Recurrence and major complication rates of

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approximately 1 per cent have been reported for conventional open surgical repairusing both the Shouldice and Lichtenstein techniques. Consequently, a series of 1732patients (i.e. 866 in each group) would be required to demonstrate an increase in thehernia recurrence rate from 1 to 3 per cent at a significance level of P<0.05 and powerof 80 per cent. A study involving 100 patients (i.e. 50 in each group) would onlydemonstrate a difference in recurrence rates of 1 per cent versus 20 per cent (P<0.05,power=80 per cent). The randomised studies to date have reported only 61, 86, 100,and 150 patients respectively, and therefore cannot be used for the comparativeassessment of hernia recurrence.

Another shortcoming of the published prospective randomised trials is the short lengthof follow-up reported. Five year follow-up is probably the minimum required toadequately assess hernia recurrence rates. Most of these data are not beingprospectively collected and the follow-up will not be available until the next decade. Aswith any procedure, further assessment bias may result from the inclusion of asurgeon's 'learning curve'. If the surgeon performing the laparoscopic procedure in atrial is not adequately experienced before the trial's commencement, the complicationrate, operating time and recurrence rate for LIER may be erroneously high. Thepre-trial experience of the surgeons involved in the published randomised trials is notstated in their publications.

Concern has also been raised regarding the methods used for the post-operativeassessment of various hernia repair techniques. The Monash University Centre for theStudy of Endosurgery has demonstrated that the use of postal or telephone surveys todetermine hernia recurrence will miss approximately 50 per cent of post-operativerecurrences. They concluded that individual examination of each patient by anindependent medical practitioner at regular intervals is the only adequate method ofpost-operative assessment for hernia repair (MeMurrick 1993). The method ofassessment used in each of the four randomised controlled trials was regular personalfollow-up in outpatient clinics. However, it is unclear whether this assessment wasconducted by an independent medical practitioner.

A large number of patients have now undergone laparoscopic hernia repair and it isevident that new, sometimes major, complications and unacceptably high recurrencerates are associated with certain techniques. Most series of significant size have hadan incidence of the complication of bowel obstruction after LIHR techniques in whichthe peritoneal cavity has been breached (e.g. intraperitoneal onlay of mesh). Theincidence of this complication has been reported to be as high as 4 per cent (Himpenset al. 1993). This complication is not confined to those techniques in which the mesh isplaced directly on the peritoneum. It is also seen with the transabdominal preperitonealtechnique in which the mesh is fixed in the preperitoneal plane with closure of theperitoneum over it. McMurrick (1993) reported an indeterminate number of patientswith significant adhesions to the prosthetic mesh which had not produced symptoms inthe short or medium term. In one patient, significant pathological changes in the smallbowel in contact with the mesh were demonstrated despite the absence of adhesions.

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The long-term outcome of adhesions between bowel and mesh is still to bedetermined. In principle, the totally extraperitoneal technique should avoid thiscomplication, although this is not yet proven.

Other outcomes

While they are inadequate for an examination of recurrence or complication rates, thesmall numbers reported in the randomised controlled trials may be sufficient todetermine differences in other outcomes such as the length of hospital stay and thetime taken to return to work.

Length of hospital stayThe trials found no significant difference in length of stay in hospital betweenlaparoscopic and open repair, except for patients having open surgery in a dayunit, whose discharge time was significantly shorter.

Post-operative painFor this outcome, there were trends but not significant differences between theprocedures, with laparoscopic surgery generally being less painful than open surgery.

Return to normal activity and workOverall, the studies indicate that patients undergoing laparoscopic repair return to worksooner than do those undergoing open repair.

CostsLaparoscopic surgery incurs more direct costs than does open repair, becauseof the additional equipment required. Any cost advantage will only be due tolower indirect costs resulting from earlier return to work.

LIHR in Australia

In order to examine the current place of laparoscopic hernia repair in Australia, in-patient statistics data from each State for the three-year period between 1992 and1994 were analysed. Over 7 000 laparoscopic hernia repairs were performed inAustralia over this period, out of a total 143 000 hernia procedures. Figure 2.1 showsthat, for the three States where full data sets exist, the numbers of laparoscopicprocedures increased dramatically between 1992 and 1993, but decreased between1993 and 1994.

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Another finding of interest is that a large proportion of hernia repair operations, bothlaparoscopic and open, are performed in private hospitals. Between 1992 and 1994,three quarters of all laparoscopic hernia repairs in New South Wales, South Australiaand Western Australia were performed in private hospitals.

The case study

This case study provides a snapshot of the introduction of LIHR in Australia. Themethodology used provided limited information of variable quality, due to differentdegrees of cooperation and record keeping at the hospitals surveyed. It is also possiblethat there was selection bias, because of the small number of hospitals surveyed. Moreaccurate information would require the initiation and funding of mechanisms for thecollection of prospective data.

Fifteen Australian hospitals were surveyed to document early experience with L1HRand current attitudes towards it. Four categories of hospitals, representative of theAustralian hospital system, were selected for site visits.

Category 1: Large public teaching (450+ beds) (n=4)Category 2: Suburban public (100-300 beds) (n=3)Category 3: Large private (75+ beds) (n=4)Category 4: Provincial base (100-300 beds) (n=4)

Hospitals where LIHR had never been performed or hospitals with a bed capacitybelow 75 were not considered for surveying. The hospitals sampled were in New SouthWales, Victoria, Queensland, Western Australia and South Australia.

Clinical and administrative viewpoints were canvassed from different perspectiveswithin the hospital system. A site visit to 11 of the 15 selected hospitals wasundertaken by a medically qualified project officer. Information was gathered fromstructured interviews with selected staff, as well as personal visits to operating theatresand instrument processing and recovery areas. Selected staff included generalsurgeons, theatre nursing staff and hospital administrators. Confidentiality of allcollected data was guaranteed under Part Vc of the Health Insurance Act 1973, beforedata collection. Questions covered a wide range of issues involving minimal accesssurgerytraining requirements for surgical and non-surgical staff, availability of trainingcourses, clinical outcomes, instrumentation and attitudes towards LIHR and its future,audit and data collection, cost effectiveness, devices and instrumentation forlaparoscopic surgery, safety considerations and individual institutional requirements.

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Of the 109 general surgeons on the staff of the hospitals approached, 70 (64.2 percent) completed the survey form. The response for each hospital category was asfollows.

Category 1 (n=30/47) response rate 63.8 per centCategory 2 (n=17/21) response rate 80.9 per centCategory 3 (n=14/28) response rate 50.0 per centCategory 4 (n=9/13) response rate 69.2 per cent

In category 1 hospitals, the following general surgical subspecialtiespredominated-upper gastrointestinal, hepatobiliary, pancreatic, colorectal, breast andendocrine. Other less common subspecialties were head and neck in combination withendocrinology, vascular and thoracic surgery. The surgeons had completed theirsurgical training between 1962 and 1994 (mean 1977).

Of the surgeons who responded, 91.4 per cent performed laparoscopic surgery at thetime, of the survey. Three surgeons had performed laparoscopic surgery previously,but had subsequently stopped, and three had no experience with the technique.

The most commonly performed laparoscopic procedure was cholecystectomy. whichwas carried out by 88.9 per cent of surgeons at category 1 hospitals, 81.3 per cent ofsurgeons at category 2 hospitals, 85.7 per cent of surgeons at category 3 hospitals,and 88.9 per cent of surgeons at category 4 hospitals. This was followed by diagnosticlaparoscopy, appendicectomy, inguinal hernia repair, Nissen fundoplication anddivision of adhesions, usually for the relief of small bowel obstruction.

Of the 64 surgeons who were performing laparoscopic surgery at the time of thesurvey, 36 had stopped performing certain laparoscopic procedures. LIHR was themost common laparoscopic procedure discontinued by the surgeons surveyed. Thereasons for this will be discussed later.

Nearly 40 per cent of the surgeons stated that all or nearly all of their patients asked tohave laparoscopic surgery. In many instances, however, this applied to laparoscopiccholecystectomy only. Far fewer patients requested less established procedures suchas LIHR.

Eighty-five per cent of the surgeons had published one or more articles in scientificjournals.

Training of surgeonsThe first supervised laparoscopic procedure performed by the large majority ofsurgeons was laparoscopic cholecystectomy. For the remaining surgeons the firstsupervised laparoscopic procedure was either tubal ligation with clips, colectomy,diagnostic laparoscopy, inguinal hernia repair or anti-reflux surgery. The first

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unsupervised laparoscopic procedure was a laparoscopic cholecystectomy for most ofthe surgeons. The mean number of supervised laparoscopic procedures undertakenbefore proceeding unsupervised was 7.2.

Surgeons were asked if they felt under any pressure, either general or specific, toundertake laparoscopic surgery. About half answered that they felt no pressure,because laparoscopic surgery is now an accepted component of general surgicaltraining, and is part of a natural evolution in surgical technology. The majority ofsurgeons who did feel under pressure to undertake laparoscopic surgery indicated thatthe economic pressures of private medicine required them to adopt the newprocedures.

Surgeons were asked to indicate the methods used to obtain necessary training inlaparoscopic techniques. These included video, lecture, theatre demonstration, use ofanimal models and supervised hands-on experience. Two surgeons gained theirexperience entirely by visiting experts in overseas clinics.

Laparoscopic hernia repair

At the time of the survey, twenty-three general surgeons performed LIHR and onesurgeon planned to begin using the technique. Twenty-two surgeons had performedLIHR previously and 21 surgeons had never used the technique (see Table 2.1) Thesedata must be interpreted carefully as the survey involved only hospitals where LIHRwas performed. The actual proportion of Australian surgeons applying the procedure islikely to be significantly less than 35 percent. The mean year in which surgeons firstwatched a LIHR procedure was 1991 (range 1990-93). Four surgeons first saw theprocedure overseas. The mean year surgeons first performed a LIHR was 1992 (range1990-95).

Table 2.1 Number of surgeons performing LIHR

Laparoscopic Category 1 Category 2 Category 3 Category 4 Totalhernia repair

Currently 13 5 2 3 23Plan to 1 - - 1Used to 7 5 7 3 22Never 7 7 4 3 21

67

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The reasons given for not performing LIHR by those surgeons who previously used thetechnique or who had never used the technique are shown in Table 2.2. Somesurgeons specified more than one reason for discontinuing.

Table 2.2 Reasons for not performing LIHR

Reasons Used to perform Never performed TotalLIHR LIHR

No benefits over open repair 8 8 16Type of procedure 4 2 6Concerns re bowel obstruction 3 1 4Complication rate 1 7 2 9Recurrence rate 6 3 9General anaesthesia required 2 1 3Other 2 1 1 2

1 Major intra-abdominal complications.2 Awaiting results of double blind trials and cost analysis (n=l), time consuming (n=l).

The surgeons had found out about the benefits and/or disadvantages of LIHR in themedical literature, informal peer discussions, experience, or another source such asinterstate courses or workshops, overseas meetings and/or visits to overseas centres.

Twenty-three general surgeons expected LIHR to have advantages over the openconventional procedure, while 19 were not sure. Surgeons anticipated that the possibleexpected outcomes of LIHR would be reduced pain, shorter hospital stay and earlierreturn to work (see Table 2.3).

Table 2.3 Possible expected outcomes of LIHR

Possibleexpected Category 1 Category 2 Category 3 Category 4 TotaloutcomeReduced pain 17 9 8 6 40Earlier return 15 8 7 6 36to workShorter 13 7 4 5 29hospital stayOther1 2 3 1 2 8

1 Includes: advantages of diagnostic laparoscopy (n=1); less neuralgia and chronic woundpain (n=2); more in-house expense for laparoscopic equipment (n=1); better long-termrecurrence rates especially in recurrent hernias (n=3), ability to do bilateral hernias with nofurther morbidity (n=1).

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Sixteen surgeons felt that their views about the benefits and/or disadvantages of theprocedure had not changed with experience, while 26 felt that they had. The views ofthe 13 surgeons who qualified this response are shown in Table 2.4. One surgeondiscontinued LIHR after more than 100 cases using the TA-PP technique, after findingthat the Lichtenstein open repair was easier to perform with reliable results and thatLIHR has potential long-term complications, especially adhesions. Two surgeons werestill evaluating the procedure.

Table 2.4 Change of views about LIHR by surgeons surveyed

Change of view Currently performing Used to perform LIHR LIHR

No benefits over open repair 1 3Limited application1 1 1Concerns re bowel obstruction2 1 2Enhanced belief in LIHR 1 -Other 2 1

1 Limited application in the management of recurrent hernias.2 Concern of adhesion formation and subsequent bowel obstruction was expressed with boththe intraperitoneal onlay mesh technique and the transabdominal preperitoneal approach.

Thirty surgeons had participated in an audit of LIHR. The form of the audit procedure(where stated) is shown in Table 2.5. Of the 23 surgeons performing LIHR at the timeof the survey, 86.9 per cent were involved in some form of ongoing prospective clinicalaudit. The five surgeons who had participated in prospective randomised trials weremainly from hospitals in Adelaide and Brisbane, which have made significantcontributions to the few trials of LIHR conducted in the world.

Table 2.5 Types of clinical audit of LIHR undertaken by surgeons surveyed

Type of audit Number of surgeonsNumber audit only 2Self audit 5Ongoing audit 15Randomised controlled trial 5Presentation of results at meetings 10Other 3

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Twenty-two surgeons said that some of their patients had asked specifically for LIHR.Thirty-one surgeons said that no patients, or hardly any, had asked specifically forLIHR. The types of LIHR performed were intraperitoneal onlay mesh, transabdominalpreperitoneal approach and the totally extraperitoneal approach.

Complications encountered by surgeons who had performed LIHR are listed in Table2.6. These data are not quantitative unless stated in the text. Significantly, 11 surgeonshad encountered at least one case of small bowel obstruction, a complication which isextremely rare following open surgery. Ten mesh related complications, 21experiences of hernia recurrence and 16 of neuralgia were also reported.

Table 2.6 Complications encountered by surgeons performing LIHR

Laparoscopic Category 1 Category 2 Category 3 Category 4 Totalprocedure

Recurrence 6 6 5 4 21Neuralgia 7 4 3 2 16Small bowel 4 4 1 2 11obstructionMesh related 4 1 3 2 10Trocar site 5 1 3 1 10herniaBladder injury 1 - - 1 2Vascular injury - - - 1 1Haematoma/bruising of 2 1 1 1 5scrotumColon injury - 1 - 1 2Other 1 1 1 2 5None 5 2 1 - 8

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Surgeon's opinions about the rate and severity of complications of LIHR compared withopen repair are summarised in Table 2.7.

Table 2.7 Rate or severity of complications of LIHR compared to open repair

Rate or severity ofcomplications of Category 1 Category 2 Category 3 Category 4 TotalLIHR

More severe 4 2 2 1 9Higher recurrence rate 1 1 - 2 4Higher complications 1 1 2 1 5Similar or no worse 9 1 1 2 13Much less 1 1 1 - 3Lower complication rate 2 3 1 1 7Other 1 2 - - 3

Nineteen surgeons performed either LIHR or open inguinal hernia repair as day cases.Two surgeons did all hernia repairs as day cases and five surgeons indicated that thiswas confined to open tension-free Lichtenstein type repairs under local anaesthetic andintravenous sedation. Two surgeons did both LIHR and open repairs as day cases.One surgeon stated that most patients leave hospital in less than 24 hours after LIHR.However, these procedures are carried out on an afternoon operating list, necessitatingan overnight stay. Two surgeons stated that all their patients stayed overnight. Foursurgeons occasionally undertake day case inguinal hernia repairs. Fourteen surgeonsdid not perform any day surgery for inguinal hernias.

The mean average length of stay reported for patients who had an open herniorrhaphywas given as 1.86 days (range 1-4; mode 1; n=37). The mean average length of stayfor patients who had LIHR was given as 1.49 days range 1-3; mode 1; n=38). Eighteensurgeons reported no difference in the average length of stay between LIHR and anopen repair. The time in days for patients to return to normal activities or work followinga hernia repair varied considerably, both for LIHR and open repair, with most surgeonsgiving a range. Many stated that this is strongly influenced by the type of occupationand the patient's self motivation, with patients who are self-employed returning earlier.For LIHR, return to work varied from two days for sedentary duties up to 42 days forheavy physical work, with most patients returning to sedentary work within seven daysand heavy work by 21 to 28 days.

For an open repair, return to work varied from seven days for the self-employed orthose with sedentary duties up to 60 days for those performing heavy physical work,with most patients returning to sedentary work within 14 days and heavy work by 42days. It should be remembered that these data are generally the surgeons' personalestimation of their own and others' results.

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Because of the nature of the survey, there is a significant risk of underestimating thepossible adverse outcomes associated with surgery, as well as the length of stay andrecovery times.

Laparoscopic instrumentation

Forty-eight per cent of surgeons stated they had concerns about the performance andsafety of re-usable instruments. Some surgeons, despite having concerns aboutre-usable instruments, were compelled to use them for cost reasons, particularly inselected public hospitals. Thirty-two surgeons had no concerns about the performanceand safety of re-usable instruments.

Many surgeons disagreed with the re-use of 'single-use' instruments, because ofconcerns about sterility and medicolegal implications. Fourteen surgeons felt 'singleuse' instruments could be re-used if adequate sterilisation could be guaranteed.

Specific responses from heads of surgical divisions

Eight of the fifteen heads of surgery approached completed a questionnaire abouthospital requirements for credentialling surgeons to practice laparoscopic surgery.

Specific credentialling requirements for surgeons to practice laparoscopic surgery werein place at only one of the eight hospitals which responded. These are described in the'RACS guidelines-animal course and supervision of six to 10 cases'. This matter wasunder review at another hospital. However, general credentialling, such as thatnecessary for accreditation as a general surgeon in Australia, was required by allhospitals. One hospital used 'peer review, discussion, and common sense' to helpascertain a surgeon's laparoscopic ability and another used personal contact and thereferences of colleagues.

Only one of the credentialling committees had a formal procedure to decide whetheradditional training was required for new procedures. This hospital required thesubmission of 'a full protocol of study and a consent form for the new procedure'. Thesurgeon was also asked to show evidence of adequate training to the credentiallingcommittee and submit a personal audit report after six months. Credentialling wasunder review at another hospital. In most hospitals, credentialling decisions were madeinformally. At one category 4 hospital, all surgeons undertaking new proceduresvoluntarily undertook training courses, with visits from experts arranged and stafftraining courses conducted. At the time of the survey, only one of the eight hospitalsrequired any individual surgeon to obtain additional training for any procedures beforecredentialling.

The mean number of laparoscopic procedures per year considered necessary bysurgeons to maintain laparoscopic skills is given for seven of the hospitals in Table 2.8(range 5-100).

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Table 2.8 Mean number of laparoscopic procedures required annually tomaintain laparoscopic skills

Hospital category Number of laparoscopic procedures

1 30-501 20-302 53 1004 504 204 75-100

Laparoscopic training was integral to the general training program of surgical traineesat five of the hospitals. Procedures to guide surgeons wishing to introduce newtechnology or techniques existed in only four of the eight hospitals. These includediscussion with hospital administration of procedures to be done and necessaryequipment and staff training, ethics committee approval, and, the presence of strongresearch interests with both technical help and animal house facilities available. Anaudit process was in place for new surgical techniques at five hospitals. Audits of LIHRhave been largely limited to personal audit by the responsible surgeon. One hospitalhas conducted randomised controlled trials comparing LIHR with open repair.

The introduction of laparoscopic surgery had increased surgical throughput in sixhospitals. This was felt to be due to word of mouth and greater referrals, subsequent toreduction of the average length of stay.

Responses from nurse theatre managers

Nurse theatre managers at the hospitals were asked a series of questions about theimpact of laparoscopic surgery on nursing practice at their hospital. No hospitalstipulated a minimum number of training hours required for perioperative nurses tobecome proficient in laparoscopic techniques. The introduction of laparoscopic surgeryrequired additional theatre staff at only three hospitals, predominantly to maintain andclean laparoscopic equipment.

Specific training for nurses in laparoscopic procedures was provided at eight hospitalsand included: management of suctioning and irrigating equipment; setting up of theinsufflator and monitor; management of the video recorder and light source; and thehandling of laparoscopic instruments. Although theatre nursing staff frequently functionas the camera operator, specific training in this was provided by only a few hospitals.

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Ten of the 13 nursing theatre managers who responded felt the introduction oflaparoscopic surgery had altered the role of the registered nurse in theatre.Peri-operative nursing staff have had to become familiar with current laparo-scopic techniques and the ever changing technology associated with this type ofsurgery. Their role is seen as increasingly more technical, for example they have to befamiliar with the functioning of video monitors and cameras, be able to determineproblems with electrical equipment and keep up to date with required sterilisingtechniques and new instrumentation. Continuing education is considered essential toensure proficient use of equipment and to keep up with the constant changes in bothequipment and laparoscopic procedures.

Laparoscopic surgery places more demands on nursing staff hours. More time isrequired for the preparation and setting up of laparoscopic procedures than in theequivalent open operation. Instrumentation for open surgery has to be available in caseconversion to an open operation becomes necessary. Initially, many hospitals had alimited number of sets of laparoscopic equipment, requiring nursing staff to spendincreased time cleaning laparoscopic instruments between procedures. However, asmore equipment has been purchased, much of this role has been transferred to theCentral Sterile and Supply Departments (CSSD) of hospitals.

Theatre nurse managers were asked to comment on the introduction of laparoscopicsurgery at their hospital. Three felt the introduction lacked structure and planning, andthat more in-service teaching by surgeons was required.

Issues of most concern to the nursing theatre managers were:

• cost effectiveness within stringent budgets;• the rapid throughput of cases e.g. laparoscopic cholecystectomy;• the current lack of consultation about the introduction of new techniques and the

need to involve nurses in planning future directions for MAS;• patient and staff education about laparoscopic procedures;• reduced hospital stay for patients;• the high cost of consumables, instruments and equipment and the need to

constantly upgrade equipment;• provision of the correct instruments and equipment for specific cases and according

to the preferences of individual surgeons;• care of the instruments, which require careful handling by experienced staff;• shortage of laparoscopic instruments necessitating the use of glutaraldehyde to

decontaminate;• difficulty in ensuring adequate cleaning of instruments and equipment, especially

cannulated instruments; and• the increase in waste products and the impact on environment.• access surgery•

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Information obtained from hospital administrators

Seven of 15 administrators returned questionnaires but these were largely incompleteas much of the data requested were not readily available.

Laparoscopic general surgery was introduced in the seven hospitals between 1990 and1992. Its use has decreased length of stay and increased surgical throughput in fourhospitals, and increased hospital theatre requirements in all hospitals. Theserequirements include:

• capital costs for equipment, instruments and operating time;• time required to set up, clean and maintain equipment and instruments;• increased budget costs for disposable consumables; and• staff education.

Laparoscopic surgery rates at all hospitals increased sufficiently to necessitatemajor equipment purchases over the period 1989-95.

The waiting times for hernia surgery at three of the seven hospitals surveyedare shown in Table 2.9.

Table 2.9 Waiting times for laparoscopic and open hernia repairs

Hospital category Laparoscopic surgery Open surgery

Category 2 3 months 3 monthsCategory 2 6 months 12 monthsCategory 3 None None

Issues of most concern to hospital administrators were:

• supplies of equipment which are inadequate for the continuing expansion of thetechnique;

• occupational health and safety issues, particularly related to the use ofglutaraldehyde to sterilise instruments;

• insufficient time to clean equipment between cases;• disinfection of scopes, light lead and camera;• cost effectiveness within stringent budgets;• patient and staff education about laparoscopic procedures;• reduced hospital stay for patients;• quality care, positive patient outcomes and patient satisfaction, and cost• control; and• increasing costs in the operating theatre in relation to disposable equipment and

insurance companies prosthesis rebate on disposables.

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Information from equipment supervisors

Nine of the 15 equipment supervisors completed a questionnaire, the results indicatingthat a range of techniques are used to sterilise laparoscopic equipment. Theseincluded steam or gas autoclave sterilisation, the use of gluteraldehyde disinfectant,and the use of disposable equipment where possible.

Information from instrument processing supervisors

Eleven of the 15 instrument processing supervisors approached completed thequestionnaire.

In most hospitals, the cleaning of instruments was done by a combination of nursingstaff, usually registered nurses, and CSSD staff. In some hospitals, cleaning by thenursing staff had to be completed after hours.

The level of training required to clean laparoscopic instruments varied from gainingexperience on the job to a CSSD certificate.

The cleaning techniques used by the different hospitals varied. Most methods ofcleaning involved dismantling the equipment where possible, then soaking in anenzyme solution followed by manual cleaning using soft instrument brushes and warmto hot soapy water or detergent. Some hospitals used a washer sanitiser or ultrasoniccleaning, depending on the equipment involved. Most hospitals used a water or air gunin the cleaning process. Routine safety precautions taken when cleaning included:wearing of goggles, gloves, aprons and face visors; removal of sharps before transportto CSSI); and careful handling and inspection of all items. The major causes ofinstrument breakage were incorrect usage, overuse, excessive force and abrasion ofinsulation covering.

Nine out of 11 hospitals did not re-use 'single use' instruments.

Discussion

This study highlights potential problems with laparoscopic inguinal hernia repair, withthe opinion of surgeons divided over the role of LIHR in modern surgical practice.Several issues need to be addressed. While the majority of uncontrolled. seriespublished in the surgical literature are optimistic about the outcome and. validity of thisprocedure, the case study has raised safety and efficacy concerns held by manysurgeons. The potential for publication bias may conceal or delay the reporting ofpotential problems. Nevertheless, both the literature review and the case studyhighlight the risk of complications unique to the laparoscopic approach, and the lack ofcurrent information available to give the procedure a true perspective.

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In the case study, most surgeons surveyed were concerned about the lack of anylong-term outcome studies and the absence of information about long-term recurrencerates for this new procedure. The fact that laparoscopic techniques are still evolvingsuggests that the ideal laparoscopic technique for inguinal hernia repair is unclear. Italso reflects the divergent opinions held in the surgical world about the appropriatenessof the laparoscopic approach to inguinal hernia repair, and concerns about the possiblerisks to patients due to new and potentially serious complications. The long-term risksof adhesive bowel obstruction with or without strangulation remain of great concern tothose surgeons who have stopped performing the procedure. Many surgeons considerthat a 'simple' operation that can be done under local anaesthetic has been convertedinto a more 'complex' one requiring general anaesthesia. In many hands, LIHR remainsa time consuming operation with unproven cost benefits. The controversy surroundingL1HR and the fact that the advantages have not. been objectively demonstrated haveled many surgeons to review the techniques they use for open hernia surgery.Consequently, open mesh repair (Lichtenstein) and the preperitoneal (Nyhus)operations have become more popular.

The main issue, which is highlighted by the literature review and reinforced by the casestudy, is the need to establish longer term outcomes of LIHR and other minimal accessprocedures. For this, accurate and complete follow-up data are imperative. This needapplies to all laparoscopic procedures. As well as the risks of recurrence and bowelobstruction following LIHR, patients currently undergoing endometrial resection mayultimately require hysterectomy, and patients now undergoing laparoscopic colectomymay yet develop recurrent carcinoma at rates different from those seen followingconventional resection. Patients need to know both the short and the long-termoutcomes of a specific procedure before they can make an informed decision abouttreatment methods. Such information is often not available. Thus long-term follow up oflarge numbers of patients, with rigorous audit of the procedures in question, isnecessary.

The usefulness of audit data would be enhanced by the central pooling of outcomedata for new procedures. Such centralised collection would more rapidly identifyproblems with such procedures (eg new and different complications, poor outcomes),allowing corrective action to be taken and surgeons to be alerted to adverse outcomes.The future assessment of new minimally invasive surgical technologies will requireimproved infrastructure for data collection and prospective audit, as well as the fundingand utilisation of other methodologies such as prospective randomised trials. Otherissues highlighted by the case study include:

• widespread differences in the adoption and application of laparoscopic surgery inAustralia, and particularly of more controversial procedures such as LIHR;

• the need for a national system for credentialling surgeons to perform laparoscopicsurgery; and

• the fact that there is clearly no consistency in instrument cleaning or sterilisingprocedures.

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The case study approach used in this assessment had limitations. The conclusionsdrawn from the data of this study should be viewed with these limitations in mind.Complete information from each hospital was impossible to obtain, compromising theauthors' ability to construct reliable study conclusions. Several factors contributed tothis.

• Cooperation varied between institutions, with complete data provided by only threehospitals, one hospital failing to participate, and the response rates of otherinstitutions varying widely.

• The nature of the study method required the retrospective collection of morbidityand outcome data, which in many instances was simply not available.

• Hospital staff often provided broad information based on memory and, in someinstances, speculation.

• To properly assess the introduction of new technologies, the quality of theinformation base must be improved. Doing this requires resources which manyhospitals are unable to provide.

Conclusions

• At present there are insufficient outcome data available to make an informedjudgement on the place of laparoscopic inguinal hernia repair, given the currentstate of its application in Australia.

• In the hands of experienced surgeons, laparoscopic inguinal hernia repair appearsto offer similar short-term outcomes to open repair. The issue of complications andlonger term recurrence remains controversial.

• Surgeons who perform laparoscopic inguinal hernia repair should enter patientsinto well designed, randomised controlled trials, or at least continually audit allpatient results including long-term follow-up.

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Laparoscopic assisted hysterectomy

3 Laparoscopic assisted hysterectomyThe two most common indications for hysterectomy are dysfunctional uterinebleeding and uterine fibroids, which result in disorders of menstruation suchas menorrhagia. These affect about 20 per cent of otherwise healthy womenand represent up to 12 per cent of all gynaecological consultations (Bradlow 1992).Hysterectomy provides an effective solution for the management of menor-rhagia in women who have not responded to medical management. Uterineleiomyomas account for 30 per cent of all hysterectomies, dysfunctional uterinebleeding for 20 per cent, endometriosis and adenomyosis for 20 per cent andendometrial hyperplasia for 6 per cent (Carlson et al. 1993).

In Western societies, hysterectomy is usually the second most common majoroperation performed after caesarean section. The prevalence of hysterectomyvaries widely across countries and within regions, with as much as a six-foldvariance across different countries. The highest rates per thousand have beenrecorded in the USA (5.56), Canada (4.70) and Australia (3.97). New Zealand(2.50), UK (1.45), Sweden (1.32) and the Netherlands (0.38) have reportedmuch lower rates (Hirsch 1993, Van Keep et al. 1983).

While the incidence of hysterectomy has been falling in most countries sincethe 1970s, the lifetime risk of having a hysterectomy is 22 per cent in Europeand almost 50 per cent in the USA (Bunker 1976). Australian studies indicatethat 34.2 per cent of women over 50 years of age and 16.9 per cent of all womenhave undergone this procedure (Scholfield et al. 1991).

Methods of hysterectomy

Conventional methodsThe two methods for performing hysterectomy are abdominal hysterectomy(open laparotomy) and vaginal hysterectomy. Since the 1940s, when thenumbers of women undergoing hysterectomy increased dramatically through-out the world, total abdominal hysterectomy has become the dominant procedurein most countries. Although it is generally agreed by Western gynaecologiststhat the vaginal route provides a safe and cost-effective way of removing theuterus with the least morbidity and mortality, there are a number of commoncontraindications which have precluded its use in many cases. However, thereis increasing evidence that some of these contraindications do not preventsuccessful vaginal hysterectomy, and this balance may alter in the future.

Australian Health Insurance Commission data indicate that Medicare benefitpayments in 1991/92 accounted for 68.7 per cent abdominal and 28.5 per centvaginal hysterectomies. The same source (Hirsch 1993) revealed a slight increasein vaginal and decrease in abdominal hysterectomies between 1989 and 1992.

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Despite reviews, articles and editorials over the last 20 years which haveexamined the indications, appropriateness, complications and cost effective-ness of hysterectomy, there is still a need to assess how this procedure affectsthe quality of women’s health care. A second primary goal of health careprovision is to contain health care costs, particularly in relation to surgicalprocedures involving expensive new technology. Since its introduction, laparo-scopic assisted hysterectomy has added to the debate about the currentutilisation and cost effectiveness of hysterectomy.

Laparoscopic assisted hysterectomy (LAH)Australian gynaecologists began using laparoscopy in the late 1960s, havingpreviously performed culdoscopy to inspect the pelvic organs. The techniquewas originally used for diagnostic purposes, but was soon expanded to carryout sterilisation, diathermy to treat endometriosis and treatment of simpleovarian cysts. Laparoscopic assisted hysterectomy was first performed in 1989,and held the promise of avoidance of laparotomy, in many cases day surgery,shorter convalescence and quicker return to full activity. It was also thoughtthat the benefits of endoscopic surgery could extend beyond recuperativeadvantages for patients and include improved visibility, better assessment ofpathology and obvious potential for therapy at the time of diagnosis.

Since its introduction in Australia, LAH has created considerable debateamong gynaecologists as to its appropriateness in comparison with traditionalhysterectomy. A policy statement issued by the RACOG/AGES gave theindications for this procedure in 1994. A Consensus Statement on LAH wassubsequently published in the journal Gynaecological Endoscopy (Petrucco &

Fraser 1994). Although the procedure is carried out in increasing numbers ofwomen, it is still too early to assess whether the technique will reduce thenumber of abdominal hysterectomies.

Laparoscopic assisted hysterectomy has not gained widespread acceptance.Data from each State’s inpatient statistics indicate that between 1992 and1994 less than 4 per cent of all hysterectomies were performed laparoscopically(see Figure 3.1). The Medicare database indicates that, in the years 1994 to1995, 8 per cent of hysterectomies were performed laparoscopically. Of over1 000 gynaecologists in Australia, only 162 had attempted the operation and ofthese 105 had performed fewer than three operations (Molloy & Crosdale 1996).

Types of laparoscopic assisted hysterectomyThe main differences between the various surgical approaches is the degree towhich the operation is performed vaginally. Consensus has not been reachedon a classification system and there are many overlapping terms used todescribe various procedures.

The main classification in LAH is whether the uterine artery is divided laparo-scopically or vaginally. If the uterine artery is divided laparoscopically, theoperation is commonly termed a laparoscopic hysterectomy. In this case the

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laparoscopic steps may also include other parts of the operation. Where thevaginal vault has been closed laparoscopically, the term total laparoscopichysterectomy is generally used.

Laparoscopic subtotal hysterectomy covers the other main group of operations.It involves leaving the cervix and excising and removing the body of the uterusafter dividing the ascending uterine artery. Ablation or excision of the endo-cervical canal to remove any remaining endothelium and the transformationzone of the cervix may also be involved.

Evaluation of LAHAssessment of the role of LAH has been made difficult for a number of reasons:

• lack of agreement among gynaecologists about relative indications for vaginaland abdominal hysterectomy;

• lack of agreement as to what constitutes a laparoscopic hysterectomy;

• controversial role of expensive but time efficient disposable equipment(Nezhat et al. 1994);

• comparisons between vaginal hysterectomy and LAH have further confusedthe issue, with claims that LAH is superior in a number of areas; and

• the introduction of laparoscopic subtotal hysterectomy which lessens therisks of some complications.

Summary of the literatureA literature review was based on a Medline search using the terms laparoscopyand hysterectomy. Relevant journals not listed on the Medline database weresearched manually. The full literature review is presented in Appendix 2.

Much of the published data on LAH refer to small, uncontrolled groups ofpatients operated on by gynaecologists with an interest in laparoscopic surgery.Patients who suffer severe complications are not always reported in thesepublications as often they are involved in protracted legal proceedings.Selection bias and under-reporting of difficulties and complications arecriticisms justly levelled at such reported series.

Case selection for different hysterectomy procedures remains a contentiousissue for several reasons.

• The LAH procedure was introduced primarily to reduce the number of abdominalhysterectomies performed by open laparotomy in patients who are unsuit-able for vaginal hysterectomy. Thus the procedure referred to as laparoscopicassisted vaginal hysterectomy (LAVH) converts an abdominal hysterectomyto a vaginal procedure. However, there is great variation in the choice toperform vaginal hysterectomy—some gynaecologists exclusively performvaginal hysterectomy and thus would not consider a need to perform LAH.

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• During the surgeon’s learning curve of experience, patients who would havebeen suitable for vaginal hysterectomy may be selected for LAH to facilitatelearning the new procedure.

• The experience of the gynaecologist as an endoscopist determines the degreeof pathology and therefore surgical difficulty related to pelvic adhesions,severe endometriosis and uterine size that would be considered acceptablefor performance of LAH.

• Endoscopy experience also determines the number of LAH cases that areconverted to open procedures to complete the operation.

Reports that compare LAH with non-randomised abdominal hysterectomyprocedures may suffer from selection bias for any of these reasons.

Like many other advanced laparoscopy techniques, the introduction of LAHinto gynaecological practice has been without proper assessment or comparisonby prospective, randomised trials to traditional hysterectomy procedures.Generally the only outcome data are from personal series, often involvingretrospective analysis of LAH against traditional open procedures. Fourrandomised controlled trials have compared LAH with abdominal and vaginalhysterectomy. It could be argued that comparison against vaginal hysterect-omy is of limited use as the clinical outcome of the two procedures is likely tobe very similar. However, cost comparisons between the two are useful.

Conclusions from the randomised prospective studies• For the LAH versus abdominal hysterectomy studies, patients were selected

either by computer generated or odd and even hospital record numbers. Allhad bilateral oophorectomy performed as well as hysterectomy. The vaginalhysterectomy versus LAVH cases were selected by computer generated andrandom numbers table.

• One of the vaginal hysterectomy versus LAVH studies had some absolutecontraindications as exclusion criteria.

• A variety of surgical techniques were used, with differences in the amount ofthe surgery performed laparoscopically.

• The operating time was approximately doubled for the laparoscopic pro-cedures, particularly when oophorectomy was also carried out.

• Patients having laparotomy procedures had a significantly increasedanalgesia requirement. No significant difference was found between vaginaland laparoscopic hysterectomy groups.

• Patients having LAH returned to work or normal activities more quicklythan did those having abdominal hysterectomy, but there was no suchdifference between LAH and vaginal hysterectomy.

• Meaningful comparison of complications was difficult because of the smallnumbers involved. Essentially none of the trials found a significant differencein this parameter. There was lack of uniformity in reporting complications.

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• Conversion to laparotomy occurred twice in each of three studies. Injury toblood vessels or the bladder accounted for the majority of conversions.

• An increased cost for LAH was demonstrated in all four studies with asmuch as a five-fold increase when disposable endoscopic equipment wasused. To compensate for the increase in cost of LAH it was felt that con-sideration should be given to the reduced bed days and potential indirectcommunity savings related to faster return to normal activity after LAHthan after the abdominal procedure.

Conclusions from the prospective/retrospective non-randomisedstudiesA number of small, non-randomised prospective and retrospective studies havecompared various types of LAH with abdominal and vaginal hysterectomy. Themain parameters compared were operating times, bed days and costs. Findingsfrom these studies were similar to those of the randomised prospective trials.Interpretation of results is again difficult because of small numbers and possibleselection bias. Laparoscopic procedures were associated with a statisticallysignificant increase in operating time but required less post-operative analgesiaand patients recovered more quickly. These studies confirmed an increase incost for LAH associated with increased theatre utilisation and use of dispos-able equipment. At least three retrospective studies have found comparablecosts for LAH and abdominal hysterectomy when non-disposable (i.e. re-usable)equipment was used for the operation. The use of electrocautery or suturingtechniques would be expected to lengthen the time of surgery and thereforetheatre use in comparison with using disposable staples.

Conclusions of studies comparing laparoscopic subtotal withLAH or abdominal hysterectomyLimited retrospective data are available for evaluation. In general, thelaparoscopic subtotal operation takes longer to perform than do laparoscopicassisted vaginal hysterectomy and abdominal hysterectomy. Some studiesindicated shortest hospital stay for the laparoscopic subtotal procedures withleast morbidity and quickest recovery interval. Overall, there are insufficientdata to be able to make a meaningful comparison of complication rates andcosts. Approximately 10 per cent of the subtotal group of patients were foundto have ongoing cyclical vaginal bleeding which may require further surgicalintervention.

LAH in AustraliaTo assess the current status of LAH in Australia, inpatient statistics from eachState for 1992 to 1994 were analysed. This analysis shows that over 3 000laparoscopic hysterectomies were performed in Australia during this period,representing 3.6 per cent of all hysterectomies. While the overall percentage isstill low, the number of LAH procedures has increased significantly each year

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in the three States for which full data sets exist (see Figure 3.1). The increasein laparoscopic procedures as a proportion of all hysterectomies was mostapparent in South Australia.

Figure 3.1 Number of laparoscopic hysterectomies by Sta

0

100

200

300

400

500

600

700

91/92 92/93 93/94

Yea

No

. o

f h

ys

tere

cto

mie

s

NSWSAWA

Figure 3.2 Average length of stay for hysterectomy1 9 9 2 – 1 9 9 4

2.5

8

5.7

5.8

3.6

5.1

5.3

8.1

8.6

7.4

8.4

6.8

8

7.6

0 2 4 6 8 10

NT

ACT

WA

SA

Qld

Vic

NSW

Non-laproscopiLaproscopic

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In all States there was a significant difference in average length of stay inhospital of up to three days between laparoscopic and open hysterectomies (seeFigure 3.2). This difference is likely to be greater if the non-laparoscopic groupis broken down into abdominal and vaginal hysterectomies, and LAHprocedures are compared with abdominal procedures.

As with hernia repair, over two-thirds of LAH procedures in New South Wales,South Australia and Western Australia were performed in private hospitals. InQueensland, about half are performed in suburban district hospitals and halfin large private hospitals.

Quality assurance auditUnlike the laparoscopic hernia case study, it was decided that the currentliterature review and prospective RACOG quality assurance (QA) audit wouldform the basis of the evaluation of LAH. This audit was to assess the currentand planned use of LAH by Australian gynaecologists. It consisted of apreliminary survey of all Fellows followed by a prospective audit of LAH.

Preliminary surveyA RACOG/AGES sponsored survey form was sent to all RACOG Fellows inMay 1994. This aimed to explore current and planned use of LAH, howtraining to perform LAH was achieved, surgical methods for performing LAHand an assessment of outcome, including bed days, return to normal activityand relevant complications. Participants were also asked whether they wouldparticipate in the prospective LAH audit. A small working party was formed todesign and oversee the project, and comprised Fellows representing theRACOG and AGES and the coordinator of research and quality assurance atthe RACOG. Funding was provided by the Department of Health and FamilyServices.

The response rate was 63 per cent of total RACOG membership (678respondents) which was satisfactory, given that many Fellows were notpractising advanced endoscopic surgery and thus would not have responded.One hundred and thirty two Fellows indicated that they would take part in theprospective LAH audit, which was to take place later on.

Numbers currently performing LAHOf the respondents, 181 Fellows (26.7 per cent) indicated that they wereperforming LAH and 60 anticipated they would be doing so within 12 months.

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Year No. of Fellows

1988 1

1990 2

1991 12

1992 42

1993 61

1994 16

TrainingWhile only 181 respondents indicated that they currently practised LAH, 315had been trained to perform LAH. The mode of training varied greatly and ananalysis of the 176 respondents to this question revealed that the mostcommon means of training were:

• lectures 160• video 176• theatre demonstration 151• supervised practice 121• RACOG/AGES workshops 98• surgical company 123

or a combination of the above, including 57 respondents who had experiencedall types of tuition and 23 who omitted only the RACOG/AGES workshop. TwoFellows had video and lecture training only, and another two video trainingonly, while six had lecture, video and theatre demonstrations. Sixty membersof the group had not had hands-on supervision.

Of the 60 respondents who intended to perform LAH within 12 months, 43stated that they had already been trained to perform the procedure. Of the 57respondents who indicated they would start performing LAH within five years,21 (36.8 per cent) had already had training.

First unassisted LAH procedureUntil 1990, only 11 gynaecologists were performing LAH. A major uptake ofLAH occurred from 1991 to 1994. Forty-seven respondents did not answer thisquestion.

Table 3.1 First unassisted LAH procedure

Number of LAH procedures performedThe majority of Fellows (76.2 per cent) had performed 30 LAH procedures orless and were still in the learning curve phase of experience.

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Instruments No. (%)

Disposable stapling device 146 (80.7)

Bipolar cautery 20 (11.0)

Unipolar cautery 3 (1.6)

Endosutures 5 (2.8)

Endoclips 2 (1.1)

Missing 5 (2.8)

Type of LAH performedThe majority of procedures were performed with closure of the uterine arteryvaginally.

Table 3.2 Type of LAH performed

Method No. (%)

Laparoscopic assisted vaginal hysterectomy withoutlaparoscopic closure of the uterine artery 104 (57.4)

Laparoscopic assisted vaginal hysterectomy withlaparoscopic closure of the uterine artery 71 (39.2)

Semm hysterectomy 4 (2.2)

Missing 2

Laparoscopic instruments for major pediclesEighty-one per cent of procedures were being performed with disposablestapling devices.

Table 3.3 Laparoscopic instruments for major pedicles

Surgical techniques for LAHOnly 11 per cent of Fellows carried out ureteric dissection laparoscopically,while 72 per cent performed bladder dissection laparoscopically. The uterineartery was clamped vaginally by 43 per cent of gynaecologists, with 40 per centusing disposable stapling devices.

Days in hospitalThis question was answered as an estimated average of patients treated. Thedata on days in hospital indicated that 82 per cent of gynaecologists haddischarged patients within three days while 17 per cent of patients remainedin hospital four to five days.

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Return to normal activity/workOf the respondents, 66.3 per cent indicated up to 21 days for return to normalacitivity or work, 25.1 per cent up to 28 days and 8.6 per cent more than 28 days.

Complications related to LAH proceduresThe following complications were noted:

• failure to complete LAH• injury to urogenital tract• bowel injury• haemorrhage• DVT/pulmonary transfusion• febrile morbidity.

The incidence of all these complications was low and in general similar to thatexpected for abdominal and vaginal hysterectomy. Because these figures werebased on recall, the results of the prospective LAH study were felt to be moresignificant.

The RACOG/AGES prospective audit of LAH

Data collectionThe Minimal Access Surgery Working Party supervised the project, designinga protocol for the collection of data on a form which could be read by an opticalmark reader. A patient questionnaire was also designed to collect clinicalinformation as well as the patients’ perception of the outcome of surgery andtheir satisfaction with the care provided. The data provided by the doctor wascompleted on discharge from hospital and sent to the College for analysis. Thepatient questionnaire was completed anonymously at three months after theprocedure and returned directly to the College. The intake of cases took placeover nine months from March to December 1995. Patient data were collectedfrom July 1995 to April 1996.

Of the 132 RACOG Fellows indicating a willingness to participate in aprospective LAH study, 52 finally contributed to this audit. This numberprobably represents one-third of those currently performing LAH in Australia.This was not regarded as disappointing as previous experience with RACOGQA projects indicates that some doctors lose their initial enthusiasm as theyrealise the time involved in participating.

The objectives of the audit were to:

• assess intra-operative and post-operative complications, hospital stay,analgesic use and recovery period;

• review indications for surgery and techniques employed;

• provide information on patients’ perceptions of the procedure and itsoutcomes; and

• report clinical and patients’ results to participants with their individualresults juxtaposed with the aggregate data.

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Condition First indication forsurgery recorded

Second indication forsurgery recorded

No. (%) No. (%)

Menorrhagia 330 61 51 9Pelvic pain 87 16 79 15Endometriosis 37 7 41 8Adenomyosis 14 3 18 3Ovarian disease 7 1 15 3PID 3 1 – –Dysmenorrhoea 28 5 64 12Dyspareunia 8 2 21 4Uterine fibroids 39 7 102 19Tubal disease – – 3 11Malignancy 15 3 5 1Failed endometrial ablation 5 1 21 4

No. of procedures No. of doctors

≤ 5 23

6–10 7

11–15 8

16–20 9

>20 5

Range 1–52

ResultsQuestionnaires were returned by 52 participating Fellows contributing to adatabase of 546 cases.

Number of procedures performed23 Fellows contributed five cases or less and five contributed more than 20 cases.

Table 3.4 Number of procedures performed by Fellows

The patients and their indications for surgeryThe women were aged between 23 and 83 years, the mean age being 44.5 (SD=8.3).Slightly more than half the women were employed or self-employed, with theremainder occupied in the home. Nearly 80 per cent of the women werepremenopausal. The following tables present information about the indicationsfor surgery, histopathology, intra-operative and post-operative complications,days of post-operative fever, post-operative use of narcotic analgesia andhospital days for patients undergoing LAH.

Table 3.5 Indications for surgery in patients undergoing LAH

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Intra-operative complications No.Failed procedure 7Bladder perforation 7Ureteric injury 0Bowel injury 5Haemorrhage:—Anterior abdominal wall 9—Pelvic/abdominal vessel 13—Retroperitoneal 1—Mesenteric 1—Transfusion 6

Complications No.

Transfusion 13

Post-operative fever 36

Bladder fistula 1

Ureteric fistula 1

Urine retention 7

Thromboembolism:

—Deep vein thombosis 1

—Pulmonary embolus 4

—Re-admission 18

Table 3.6 Histopathology of patients undergoing LAH

No. (%)

BenignAdenomyosis 231 (42.0)Endometriosis 54 (9.7)Fibroma 225 (41.1)PID 5 (0.9)Ovarian cyst 31 (5.7)Other 120 (21.9)Malignant 6 (1.1)

ComplicationsIntra-operative complicationsIn 474 cases (86.8 per cent), no complications were reported. Those reportedare shown in Table 3.7. In some cases, more than one complication occurred.Table 3.7 Intra-operative complications in patients undergoing LAH

Table 3.8 Post-operative complications in patients undergoing LAH

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Days of fever No. of patients (%)

1 32 (5.9)

2 9 (1.7)

3 6 (1.1)

4 2 (0.4)

5 1 (0.2)

7 missing

No. days on narcotic analgesia No. of patients (%)1 296 (54.8)2 142 (26.3)3 42 (8.0)4 11 (2.0)5 2 (0.4)6 2 (0.4)7 1 (0.2)

7 missing

Days of post-operative feverFour hundred and eighty nine patients did not experience post-operative fever(>38°C), while 50 patients were febrile for one to five days.

Table 3.9 Days of post-operative fever in patients undergoing LAH

Post-operative use of narcotic analgesia

Forty-three patients did not require narcotic analgesia.

Table 3.10 Post-operative use of narcotic analgesia in patients undergoing LAH

Table 3.11 Days in hospital for patients undergoing LAH

No. of days No. of patients (%)1 5 (0.9)2 98 (18.0)3 152 (27.9)4 125 (23.0)5 76 (14.0)6 36 (6.6)7 23 (4.4)8 16 (2.9)9 3 (0.6)

10 4 (0.7)11 4 (0.7)

Mean=4.0 days (SD=2.0) 4 missing

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Time in theatreThis ranged between 40 and 390 minutes, the mean being 116 minutes(SD=45 minutes).

Results of patient surveyIn total, 436 patient questionnaires (80 per cent) were returned. Over 40 per centof the women indicated that their primary reason for undergoing LAH wasexcessive bleeding, with abdominal pain, endometriosis, painful periods andfibroids also common reasons.

Expectations and realityIn the majority of cases, the outcome of surgery exceeded women’sexpectations; most symptoms present before the LAH were relieved (Table3.12), and there was a high level of satisfaction with the care received and theoperation itself (Table 3.13).

Table 3.12 Relief of symptoms in patients undergoing LAH

SymptomPresentbefore

hysterectomy

Muchbetter Better Same Worse Much

worse

No. (%) No. (%) No. (%) No. (%) No. (%) No. (%)

Abdominalpain 279 (64) 229 (84) 37 (74) 7 (2) 1

Back pain 182 (42) 102 (55) 57 (31) 21 (11) 3 (2) 1

Painfulintercourse 136 (31) 88 (68) 31 (24) 10 (8) 1 (1)

Low interestin sex 169 (39) 63 (39) 47 (29) 42 (26) 7 (4) 4 (3)

Incontinence 95 (22) 50 (51) 27 (28) 10 (10) 6 (6) 5 (5)

Fatigue 265 (61) 118 (45) 105 (40) 34 (13) 5 (2)

Depression 157 (36) 79 (51) 47 (30) 22 (14) 6 (4) 1

Anxiety 119 (27) 58 (49) 42 (36) 16 (14) 2 (2)

Mood changes 207 (48) 117 (56) 63 (30) 22 (11) 5 (2) 1

Non-specificvaginaldischarge

103 (24) 76 (74) 20 (19) 6 (6) 1 (1)

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Table 3.13 Satisfaction with care received and with operation itself

Verysatisfied

Somewhatsatisfied Not sure Somewhat

dissatisfiedVery

dissatisfied Missing

No. (%) No. (%) No. (%) No. (%) No. (%)

The overall resultsof the operation 396 (92) 26 (6) 4 (1) 3 (1) 1 6

The doctor’sexplanation aboutthe medical con-dition which led tothis treatment

377 (88) 42 (10) 3 (1) 6 (1) 1 7

Informationprovided by thedoctor about thedetails of thisoperation (e.g. whatwould happen, howyou would feel etc)

370 (86) 49 (11) 5 (1) 6 (1) 2 (1) 4

Informationprovided by thedoctor about thelikely outcome ofthe operation

362 (84) 52 (12) 4 (1) 9 (2) 2 (1) 7

The opportunity todiscuss any con-cerns about theoperation

374 (86) 40 (9) 5 (1) 7 (2) 2 (1) 8

Patients’ recommendationsA further question which illustrates the patients’ view of the procedure iswhether they would be prepared to recommend the operation to anotherwoman whose symptoms were similar. The response showed 95.2 per cent ofpatients would recommend the surgery. Again it is evident that most of thewomen endorsed this approach to their care.

DiscussionLAH was introduced in Australia in 1989 and is now performed in allAustralian states in limited numbers. It can be concluded that the LAHprocedure has gained limited acceptance in Australia so far.

Assessment and introduction of LAHFollowing demonstration of the first LAH procedure at an Advanced Endo-scopy Workshop in Melbourne in 1989, gynaecologists with an interest inadvanced endoscopy procedures attended overseas and national workshops tolearn the technique. In many instances the procedure was self taught orlearned by attendance at annual workshops, observation of surgery performed

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by more experienced colleagues, lectures and video demonstrations. Gynaeco-logists are attracted to the procedure because of reported less post-operativepain, shorter hospitalisation and speedier return to normal activity comparedwith abdominal hysterectomy. However, significant complications were reportedfrom overseas and within Australia, prompting the RACOG and AGES tocommence a survey of LAH and subsequently an audit of outcome for thisprocedure. The results of these two studies, which were funded by theCommonwealth Department of Health and Family Services, provided data forthis LAH case study. Commonwealth funds were also provided for a randomisedcontrolled study of LAH versus abdominal hysterectomy currently beingfinalised in Adelaide.

Despite these initiatives, it is important for well constructed clinical trials tobe performed nationally, especially as the surgical technique for LAH is con-stantly changing. In particular, expensive techniques involving disposableinstruments are being modified so that re-usable instruments can be used andcosts reduced.

The possible benefits of laparoscopic subtotal hysterectomy versus laparoscopicassisted hysterectomy need further assessment.

The assessment of LAH in this case study approach is limited by the relativelyfew randomised controlled studies found in the medical literature. The mainbody of literature refers to non-randomised prospective and retrospective series.

Indications are that LAH is associated with shorter hospitalisation, less needof analgesia and a faster recovery period than is abdominal hysterectomy. Themajority of studies reviewed involved the use of disposable instruments and,therefore, were found to be more expensive than abdominal hysterectomy. Thefew studies reviewed which involved re-usable instruments have suggested anequal or lesser cost than abdominal hysterectomy.

Possibly because the majority of gynaecologists contributing to the RACOGaudit were in the learning phase of experience, only 18 per cent of patientswere discharged from hospital by the second post-operative day, 28 per cent onthe third, 23 per cent on the fourth and 14 per cent on the fifth day.

Only a limited number of gynaecologists contributed to the audit (approxim-ately one third of Fellows currently performing LAH) and the conclusionsdrawn from this case study must be viewed accordingly. AHTAC recommendsthat the RACOG continues to promote prospective audits involving all Fellowsperforming LAH and, similarly, other advanced endoscopic surgery, so thatadequate national data can be collected in the shortest possible time. Majorendoscopy centres in capital cities should be funded to carry out randomisedcontrolled studies on procedures such as LAH before these procedures can berecommended for general acceptance in the Australian community.

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Adverse outcomesThe literature review and case study indicate that significant complicationsmay occur due to LAH. These complications may be related to the laparoscopytechnique itself or are more specifically due to pelvic haemorrhage, urogenitaltract or gastrointestinal tract injury.

The meta-analysis of 29 studies with 3 184 cases contributed by skilledlaparoscopists indicated that the two most common complications were febrilemorbidity (4.3 per cent) and need to convert to laparotomy (3.45 per cent).Trochar injuries (2.57 per cent), bowel injury (0.47 per cent) and urinary tractdamage (1.38 per cent) accounted for the other common complications.

A retrospective LAVH audit involving 760 cases in the learning curve experienceyears 1991–94 in South Australia indicated haemorrhagic complications in8 per cent of cases, conversion to laparotomy in 5.3 per cent and urinary tractinjury in 2.4 per cent of cases.

The prospective RACOG audit results were encouraging—this group of gynae-cologists nationwide experienced no complications in 87 per cent of the LAHprocedures. Conversion to laparotomy occurred in seven cases (1.28 per cent),urinary tract injury in eight cases (1.6 per cent) and bowel injury in five cases(0.9 per cent). Pelvic/abdominal wall haemorrhage occurred in 24 cases(4.4 per cent) with 19 patients requiring transfusion intra-operatively or post-operatively (3.5 per cent). A total of 18 patients (3.2 per cent) required re-admission to hospital. It was of some concern that four cases of pulmonaryembolism and one of deep vein thrombosis (0.9 per cent in total) weredocumented. This finding suggests that larger studies are needed to furtherinvestigate a possible relationship between LAH and thromboembolicphenomena. The RACOG prospective audit failed to demonstrate a highercomplication rate than that expected for vaginal and abdominal hysterectomy.

Training and credentialling for advanced endoscopic surgeryThe Australian Gynaecological Endoscopy Society produced Guidelines forEndoscopic Surgery which were accepted by the RACOG in 1993.

A Policy Statement in Advanced Endoscopic Surgery which includes generalconsiderations, guidelines for Fellows and College responsibilities was adoptedby RACOG Council in March 1994.

To facilitate the implementation of the suggested guidelines at a local hospitallevel, the RACOG Policy Statement on Advanced Endoscopic Surgery was sentto all State health commissions and administrations of public and privatehospitals performing gynaecological surgery in Australia.

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Important issues included:

• delineation of hospital privileges;

• membership of Hospital accreditation committees;

• evidence of competence to be submitted to accreditation committees;

• hospital responsibility to provide adequate operating facilities;

• the necessity to carry out quality assurance studies and surgical audits inrelation to new advanced endoscopy procedures; and

• the appointment of preceptors to ensure that Fellows requestingaccreditation have reached a satisfactory level of training.

Health authority correspondence to hospitals indicates that the guidelines arebeing promulgated.

Training facilities for advanced endoscopic surgeryThe AGES has conducted a yearly scientific meeting since its inception in1991. A workshop offering either hands-on experience with inanimate oranimal models has been associated with each scientific meeting. A largenumber of Australian gynaecologists have attended these workshops. MonashUniversity offers an alternate year Advanced Workshop based on animalmodels and Adelaide and Sydney Universities have offered similar workshops.Several endoscopy centres in Melbourne, Sydney, Adelaide and Brisbane areoffering workshops on advanced operative techniques including overseasspeakers on a regular basis.

The RACOG/AGES has adopted a responsible attitude to ensure that adequatetraining is provided to Fellows wanting to learn new endoscopic techniques.However, because of the limited number of experienced teachers, opportunitiesto learn on a one-to-one supervised basis remain limited. The question ofmedicolegal responsibility of preceptor and trainee remains a contentious andunresolved issue limiting training by preceptors in many institutions.

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Conclusions• Although introduced without proper initial assessment, laparoscopic

assisted hysterectomy has become an accepted gynaecologicalprocedure with limited utilisation by gynaecologists in Australia.

• Operative complications during the learning curve of experience havebeen documented in both the literature review and Royal AustralianCollege of Obstetricians and Gynaecologists audit examined in thislaparoscopic assisted hysterectomy case study report. Good qualityassurance practice suggests that a further quality assurance studyshould be encouraged.

• The incidence of complications is not high enough to warrant concernabout the safety of laparoscopic assisted hysterectomy in Australia andthe overall complication rate is not significantly different fromaccepted figures for abdominal and vaginal hysterectomy.

• Patients’ response to this new gynaecological procedure has beenoverwhelmingly positive.

• The Royal Australian College of Obstetricians and Gynaecologists/Australian Gynaecological Endoscopy Society has successfullyintroduced guidelines for training, credentialling and accreditation forperformance of advanced gynaecological endoscopic surgery inAustralia.

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4 OverviewDespite the limitations of case study methodology and the inadequacy of avail-able evidence about both LIHR and LAH, the case studies and literature reviewspresented in this report provide much information upon which to assesscurrent practice and recommend future directions in laparoscopic surgery.

Risks and benefits of LIHR and LAHBoth the literature review and the case studies highlight the possibility ofsignificant, serious new complications during or following LIHR. These includemajor vascular injury, visceral perforation, nerve damage and bowel obstruc-tion. The yet to be demonstrated benefits are less analgesic use, shorterhospital stay and earlier return to full activity. LIHR in the hands ofexperienced surgeons appears to offer similar short-term outcomes to openrepair, but if LIHR is to become a widely accepted procedure the risk of theabove new complications must be less than the risk of adverse outcomesfollowing open repair. At present, open repair is accepted as a low risk, lowmorbidity procedure. The early results of the randomised trials support thecontention that LIHR offers few advantages over the conventional approach.

Recurrence rates following LIHR are uncertain and no long-term outcomestudies are available. While some published studies claim very low earlyrecurrence rates (less than 1 per cent), this may also be influenced by follow-upmethodology, i.e. the operating surgeon may be less likely to detect herniarecurrence than an unbiased observer. At present, accurate recurrence dataare not available for LIHR. Similarly, while recurrence following open repairperformed at the Lichtenstein and Shouldice clinics is less than 1 per cent,recurrence rates may not be as low in other centres. Recurrence rates of 5 to10 per cent have been reported after open repair. Further research with wellconducted trials is essential to clarify which procedure is more likely to achievelong-term success.

The indications are that LAH is associated with shorter hospitalisation, lessneed of analgesia and a faster recovery period than is abdominal hysterectomy.It should be noted that this benefit has not been demonstrated unequivocallybecause, as with LIHR, the data simply are not available. The literaturereview and case study of LAH indicate that significant complications mayoccur which may be related to the laparoscopy technique itself or are morespecifically due to pelvic haemorrhage, urogenital tract and gastrointestinaltract injury. However, in contrast to LIHR, there is no real evidence of differentcomplications.

Data collectionThe issue most consistently raised by these case studies is the inadequacy ofthe evidence upon which to compare outcomes and make recommendationsabout laparoscopic surgery. As can be seen from the discussion of risks and

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benefits, at present there are insufficient outcome data available to make aninformed judgement on the place of LIHR, given the current state of itsapplication in Australia. The situation with LAH is different in that there is nosuggestion of any new complications associated with the procedure. However,the key expected benefit of decreased necessity for abdominal hysterectomyhas still not been demonstrated unequivocally.

The case study approach for procedure assessment has limitations, and theconclusions drawn from the data must be viewed accordingly. The nature of theLIHR case study method required the retrospective collection of morbidity andoutcome data, which in many instances were not available. Hospital staff oftenprovided broad information based on memory and in some instances specula-tion. This incomplete and speculative information compromised the authors’ability to construct reliable study conclusions.

In contrast, the LAH data were collected prospectively and are correspondinglymore complete and reliable. However, the LAH study involved gynaecologistswho had previously taken part in a pilot audit, who were already using thetechnique and who were confident in the management of the audit by theircollege. The possibility exists that these gynaecologists represent the ‘enthusiasts’and that their results differ in some way from the norm.

Quality of the evidenceConsideration of the effectiveness of any procedure must be interpreted interms of the evidence upon which it is based. The most valid and reliableevidence comes from randomised controlled trials, and well constructed trialsare critical for the unbiased assessment of new procedures. However, trials ofsurgical procedures have specific problems. There are many variables whichrelate to the patient and the operator, as well as to the technique, and patientrecruitment. There is always a learning curve for new procedures and thismust be satisfactorily negotiated by surgeons before patients can, or should, beentered into trials. Many procedures will bypass this phase if their apparentbenefits or side effects are such that surgeons are unwilling to place patientsin such a trial. These assessments may not be accurate as they are often basedon anecdotal opinion or pressures from patients and the media. If it is clearwhich treatment the patient received there may be no way to objectively assessdifferent results, and this reduces the strength of the evidence from the trial.In addition, trial data are often not available due to the delays incurred inseeking funding, entering patients, allowing time for adequate follow-up andpublication delays.

Because of these difficulties, it may not always be appropriate to use ran-domised controlled trials to evaluate a procedure. If there is an over-ridingreason why a trial should not be conducted, a rationale should be given. Otherevidence should be available for assessment, such as data from prospectiveaudit. Some surgeons remain sceptical of audit data, as comparisons with oldertechniques must depend on retrospective evidence. This introduces many

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potentially confounding variables which can bias the conclusions. LIHRillustrates this problem, as the advantages initially proposed by uncontrolledseries have not been confirmed by the early results of published randomisedtrials. The initial trial results for LAH, on the other hand, appear to confirmthe positive findings of earlier studies. It should be emphasised that theseprocedures, like laparoscopic cholecystectomy, are not lifesaving procedureswith immediately evident benefits, but merely seek to improve outcomes interms of early comfort and return to activity. Audit provides a mechanism fordiscounting ineffective treatments more rapidly, and its usefulness is enhancedby the central pooling of outcome data for new procedures. Centralisedcollection identifies problems such as new and different complications or pooroutcomes more rapidly, allowing corrective action to be taken, and surgeons tobe alerted to adverse outcomes.

To properly assess the introduction of new technologies, the quality of theinformation base must be improved. Doing this requires resources which manyhospitals are unable to provide. Using audit and prospective randomised trialsas two complementary approaches of data collection will improve this informa-tion base. In Chapter 5, a protocol for assessing new surgical procedures usingthis approach is outlined.

Prospective auditProspective audit is performed already by some individual surgeons, but willbe biased if all surgeons are not included in the audit process, as negative orpoor results are often not reported. A central, possibly anonymous, reportingmechanism, facilitated and conducted by an ‘independent’ body such as theRACS or the RACOG is more likely to gain the cooperation of surgeons whichis essential for its success. This would, however, require the funding of staffand equipment to function adequately. In addition, the process must occurquickly during the development of new procedures, rather than in reaction toconcerns after their widespread application.

Randomised controlled trialsThe second approach to improving the quality of data for the assessment processis to encourage the conduct of large and rigorously constructed randomisedtrials. Traditionally, surgical trials have been poorly supported by majorresearch funding bodies such as the NHMRC. This is due to a limited overallNHMRC research budget and competition from many other high qualityfunding proposals. However, if randomised trials are not adequately supported,the quality of available trial data will remain limited and in many instancestrials will not be conducted. There is then a real risk of procedures enteringroutine practice with very little evidence to support their safety and efficacy.Every laparoscopic procedure has been applied widely, following the limitedpresentation of uncontrolled case series data. In no instance has a procedurebeen adequately assessed before its routine clinical use.

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If traditional funding bodies are unable to resource trials, assessment could beencouraged by specifically allocating funding for trials to a research foundation.The Colleges’ research advisory committees would then be in a position tofacilitate multicentre Australian trials at an early stage, before new pro-cedures enter routine practice.

Early and specifically focused funding of centralised audit and multicentretrials, could greatly improve the quality of information available for the assess-ment of new procedures and enable more appropriate clinical decisions to bemade. The danger in not adopting this sort of approach is that potentially moreexpensive, less effective or even dangerous procedures may enter routineclinical practice. In the longer term, this will increase the financial burden ofhealth care in this country.

Case selectionVery few patients are unable to undergo open inguinal hernia repair. Patientswith a high anaesthetic risk are able to undergo the procedure under localanaesthesia, with minimal risk. However LIHR requires general anaesthesiaand medically unfit patients will be unsuitable for this approach. LIHR hasbeen used for recurrent and bilateral hernia, with some surgeons advocatingthe laparoscopic approach in these situations. Previous lower abdominalsurgery may make the transabdominal laparoscopic approach difficult,although the extraperitoneal approach overcomes the difficulties associatedwith potential adhesions from previous surgery.

The indications for surgery and age range in the LAH audit suggest that thepatients who undergo LAH are similar to those who undergo abdominal orvaginal hysterectomy. The generally accepted rationale for use of LAH is that‘a patient unsuitable for vaginal hysterectomy…can avoid abdominalhysterectomy by the use of laparoscopic assistance’.

Training and credentialling for safe MASNone of the hospitals surveyed in the LIHR case study had formal protocols toascertain the need for additional training when undertaking a new procedure.The survey suggested that the number of laparoscopic procedures a surgeonshould perform per year to maintain laparoscopic skills could vary from five to100. The literature review suggests that a long learning curve is associatedwith the different laparoscopic techniques, although the exact length remainspoorly defined. It is likely that minimum experience levels are surgeon specificrather than procedure specific. It is difficult to generalise training recommenda-tions as variables such as the complexity of procedures performed and individualaptitude differ considerably. This aspect was not analysed in the LAH auditbut it could be assumed that the same situation exists for LAH. Anyrecommendation for minimum numbers must be balanced by the frequency ofperformance of each procedure, as some complex procedures such asadrenalectomy are performed rarely.

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Surgical staffFormal training of specialist surgeons and surgical trainees in new proceduresis needed to minimise patient morbidity and mortality. The existence of alearning curve for laparoscopic techniques is well documented and the potentialfor complications greatest during a surgeon’s initial experience. WithinAustralia and other western countries, training for MAS has been poorlycontrolled and audited, and there is evidence of surgeons attempting theseprocedures without any specialised training in laparoscopic surgery. Whilesuch training may not have been available during the initial development ofnew techniques, training centres did become established quite rapidly.

There may also have been under-reporting of complications and deathsfollowing laparoscopic surgery. In New York State between August 1990 andMarch 1992, 158 adverse incidents involving laparoscopic cholecystectomywere reported to the State’s department of health, as required by legislation.A recent article in the Australian Doctor alluded to more than 40 laparoscopy-associated compensation claims presently under investigation by Melbournelaw firms (Aust Dr 1995). These predominantly concern gall bladder and gynae-cological surgery and most involve the puncturing or cutting of inappropriateorgans. Of greatest concern is the small number of reported deaths followingboth laparoscopic cholecystectomy and laparoscopic assisted hysterectomy.Such problems may be more likely in the hands of poorly trained andinexperienced surgeons.

Unfortunately there are no widely agreed specific guidelines for the trainingand credentialling of LIHR, although ‘common sense’ guidelines have beenpromulgated by learned colleges and other bodies. In the USA, variousnational organisations, such as the Society of American GastrointestinalEndoscopic Surgeons (SAGES), have delineated general credentialling criteriadespite the fact that there is no uniform state or federal legal requirement. Inthe present litigious atmosphere surrounding surgery, many hospitals in theUSA have defined their own requirements for laparoscopic credentialling. Ageneral consensus for minimum requirements seems to be:

• a course that includes didactic, inanimate, and live operating experience;

• a preceptorship as an assistant surgeon of no fewer than five cases; and

• a preceptorship of no fewer than five cases as the operating surgeon underthe guidance of an experienced laparoscopic surgeon.

Many institutions have also requested that surgeons applying for laparoscopycredentials submit tapes of their work. The issue of mandating specificnumbers of cases in laparoscopic credentialling requirements is controversial.The number of procedures required for safe training varies between individualsurgeons according to their aptitude and previous experience, as well as to thenature of the specific procedure.

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The RACOG and the AGES adopted guidelines for training and accreditationin laparoscopy in 1993. A Policy Statement in Advanced Endoscopic Surgerywhich includes general considerations, guidelines for Fellows and Collegeresponsibilities, was adopted by RACOG Council in March 1994. To facilitatethe implementation of the suggested guidelines at a local hospital level, theRACOG Policy Statement was sent to all State and Territory healthauthorities and administrations of public and private hospitals performinggynaecological surgery in Australia.

The RACOG/AGES has taken the initiative in actively and prospectivelyauditing procedures among its members. It is also attempting to ensure thatadequate training is provided to Fellows wanting to learn new endoscopictechniques. However, because of the limited number of experienced teachers,an opportunity to learn on a one-to-one supervised basis remains limited. Thequestion of medicolegal responsibility of preceptor and trainee remains acontentious and probably unresolved issue limiting training by preceptors inmany institutions. It is envisaged that the Colleges would be the mostappropriate bodies to review this matter and make recommendations to theirmembers about how satisfactory training and preceptorship can be achieved.

In 1993, the Royal Australasian College of Surgeons published a policy state-ment New Technology and Surgical Practice, which gives clear recommenda-tions for the acquisition of laparoscopic expertise. However, the publication ofguidelines for training does not ensure their adoption. The Royal AustralasianCollege of Surgeons does not certify surgeons to be competent to performspecific procedures, but supports the delineation of clinical responsibilities bylocal hospital credentialling committees. In March 1991, the RACS adopted apolicy which includes the following:

Delineation of clinical responsibilities should be determined by a credentiallingcommittee set up by the governing body of the hospital. Credentialling committeesshould consist predominantly of medical practitioners and should include arepresentative of the College, who is not a member of hospital staff.

The RACS recommends that surgical privileges should be individual specific,and privileging committees should detail criteria on which this is based. Theseresponsibilities should be reviewed for all surgeons at five-yearly intervals upto the age of 65 years and yearly thereafter. The surgical responsibilities ofadvanced trainees are the responsibility of the head of the training unit.

It is imperative that credentialling committees regularly review credentiallingcriteria appropriate to new surgical procedures. Local credentialling committeesare not protected as statutory bodies in any Australian State or New Zealandand this may influence decision making due to the potential problem ofrestraint of trade created by an adverse committee decision. It is apparentfrom the case study that the current system of credentialling in Australia isflawed. Only one of the 15 hospitals surveyed for the LIHR case study had aworking credentialling committee.

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The RACS also recommends that surgeons performing laparoscopic surgeryshould audit the indications and outcomes of procedures personally performed,and should participate in hospital/region/College-based audits on aggregateddata. A structure for the collection and analysis of such aggregated data is notpresently in place and would require additional funding. However, the RACS isbest placed to adequately monitor the performance of laparoscopic surgery.Consequently, a partnership between the Commonwealth and the College ismost likely to achieve the cooperation of practising surgeons.

Surgeons compete for their work and laparoscopic experience is actively soughtafter. Initially, this was achieved by attendance at short courses. While suchcourses may aid the training process, the technical problems of laparoscopicsurgery may be considerable. In colorectal laparoscopic surgery and laparo-scopic antireflux surgery, an advanced degree of technical expertise isnecessary, as well as experience in patient selection. Inadequate experienceafter formal course training alone has been shown to be associated with athree-fold increase in complication rates during the learning curve. The RACSencourages the development of special centres suitable for training in newtechnology and related procedures. Such units would be in a realistic positionto coordinate successful randomised controlled trials and provide answers tothe important questions still unanswered about the future role of varioustechniques.

Hands-on training courses in laparoscopic surgery for small groups of surgeonsare presently available at only two centres in Australia. These are The RoyalAdelaide Centre for Endoscopic Surgery at the Royal Adelaide Hospital, SouthAustralia, and the University Department of Surgery at the Royal BrisbaneHospital, Queensland. The former holds Basic Laparoscopic Skills andAdvanced Laparoscopic Skills courses for surgeons, ranging from two to fourdays duration. The courses typically include hands-on training using simulatorswhich incorporate abattoir sourced viscera, laboratory sessions using anaes-thetised animals and operating theatre participation for selected procedures.The structure of the training course in Brisbane is similar. The MonashDepartment for Endosurgery at the Alfred Hospital in Melbourne, has discon-tinued its courses due to a drop in demand. Specific workshops are stillconducted for certain procedures, e.g. laparoscopic gastric banding, althoughthese are restricted to invited surgeons only.

The case study suggests that requirements are currently met in a variety ofways, including workshop attendance, informal animal laboratories, on the jobtraining, and self tuition. This reflects the ad hoc way in which many newprocedures are introduced.

Non-surgical staffThe training of operating room nursing staff is usually conducted within thecontinuing education programs of individual hospitals. Major teachinghospitals are often well placed to delegate individual staff with the

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responsibility to maintain education programs. Smaller hospitals may nothave this resource, and nurses may be confronted with new procedures andinstrumentation with which they are unfamiliar. Individual instrument com-pany sales staff provide training for the use of their own equipment. Howeverthere is a general lack of information and external training for theatre staffwho play a critical role in the safe performance of laparoscopic procedures.Short courses of three days are offered every two months by the Royal AdelaideCentre for Endoscopic Surgery for theatre staff and these have been wellreceived by staff who are predominantly from private and country hospitals. Asuniversities develop postgraduate operating room nursing staff trainingprograms, the availability of update courses for laparoscopy and other newtechnologies should improve.

Cost and caseload implicationsOnly a few reports have addressed the cost benefit implications of LIHR orLAH. The financial cost to the hospital is caseload dependent and influencedby variables such as types of instruments used and technique employed.Caseload must be at a certain level before procedures become cost-effective inrelation to the capital investment in high technology equipment and specificinstrumentation. A sufficient caseload is also essential to achieve and maintainexpertise. Both of these factors are influenced by each surgeon’s and eachhospital’s rate of laparoscopy use for other procedures. The increased operatingtime needed to perform laparoscopic surgery and the use of disposable instru-ments may have a significant impact on the costs incurred in the operatingroom. Although costs decrease with increasing experience, laparoscopic herniarepair appears to consistently generate greater hospital costs than do conven-tional open surgical equivalents. This information is collaborated by anAustralian study (Hirsch 1993) which failed to demonstrate cost effectiveness tothe health services for LIHR. It is possible that costs may be offset by an earlierreturn to work, which may result in other savings to the general community,but this is unconfirmed in Australia. However, it should be noted that hospitaland community convalescence times vary widely between countries, makingAustralian outcome studies essential for determination of cost effectiveness ofany medical procedure. The issue of cost for LIHR is controversial, and difficultto quantify with advocates of the procedure using the argument of reducedcommunity cost to justify their application of LIHR. On the other hand, earlyrandomised trial evidence does not support this claim.

For LAH, cost implications arise mainly from the use of disposable equipmentfor laparoscopic surgery, which decreases operating time but increases costssignificantly. Equipment approved by private medical funds for performance oflaparoscopic gynaecological procedures has resulted from AMA recommenda-tions on laparoscopic equipment. There is no doubt, however, that publichospital budgets do not usually facilitate the use of disposable instruments ona regular basis.

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Institutional requirements

Theatre facilitiesAdequate equipment and personnel must be provided for laparoscopic surgery.This includes the provision of both visualisation and mechanical equipment tosupport a surgeon’s endeavours to provide safe, high quality surgery. Supportstaff are essential for the safe conduct of laparoscopic surgery. Exactrequirements vary between institutions and are dependent on caseload andtype of procedure. This issue is applicable to all areas of laparoscopic surgery.

EquipmentThe issue of whether disposable or re-usable items should be routinely used isnot fully resolved. The capital cost of equipment and instruments is high, butwith the non-disposable instruments currently available this initial cost isoffset by the multiple procedures for which the equipment can be used.Although the use of disposables undoubtedly increases the cost of the surgicalprocedure, factors such as reduced labour for sterilisation and equipmentmaintenance as well as the diminished risk of bowel and vascular injuriesmust be taken into consideration. The issue of re-use of disposable instrumentsis important as there are cost savings involved which may lead hospitals to re-use single use items. This issue is the subject of a separate NHMRC report.

Sterilisation protocols are a significant issue, raising much concern amongtheatre nursing staff. Glutaraldehyde in particular has become a majoroccupational health and safety issue, with staff exposure resulting in adversehealth outcomes. It is likely that this agent will be used much less in thefuture as alternative sterilisation systems become available. Existing use ofglutaraldehyde is often in breach of existing Australian standards as thisagent fails to sterilise unless used for long periods of time. Consequently,laparoscopes soaked in this agent should be regarded as disinfected only. Thesterility of any laparoscopic instrumentation soaked in glutaraldehyde cannotbe guaranteed.

Because of this and other sterilisation issues, it is very important thathospitals provide adequate numbers of instruments for laparoscopic surgery.This may reduce the difficulties associated with attempts to rapidly resteriliseor disinfect equipment between cases, which may lead to breaches in infectioncontrol standards, due to attempts to ‘keep lists moving’.

Staffing levelsStaffing considerations should include each of the following personnel:

• anaesthesiologist• camera operator• surgeon• instrument technician• first assistant.

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Exact staffing levels will depend on the nature of the laparoscopic procedure,experience of each staff member and the operating throughput of the operatinggroup. Fewer staff may be needed as operative experience increases. Surgicalprocedures are facilitated by skilled laparoscopic assistants. For complexprocedures as well as early in a surgeon’s experience, the assistance of anotherskilled laparoscopic surgeon is advised. This can still be achieved in mostcountry and private hospitals.

Day care and ward facilitiesThe survey was unable to provide specific data which addressed the issue ofminimum hospital facilities for the recovery of patients following laparoscopicsurgery.

General cost implications of minimal access surgeryA UK report commissioned by the Department of Health and the ScottishHome and Health Department (1994) has reviewed the costs of minimal accesssurgery. However, AHTAC believes that this study’s prediction that in tenyears 70 per cent of operative procedures will involve minimal access tech-niques is an overestimate. The report is mainly confined to surgical andorganisational aspects, but broader social and economic issues need to beaddressed.

Minimal access surgery has economic implications for both community healthservices and society. Reductions in length of hospital stay may require asimultaneous increase in community resources. Similarly, hidden costs mayarise from reductions in the threshold for surgical intervention and an increasein population demand. The number of cholecystectomies has risen sharplysince the laparoscopic procedure has become the treatment of choice forsymptomatic gallstones.

The average hospital stay of LAH patients in the audit was 4 days ± 2. In NewSouth Wales for 1993–94, the average bed stay for hysterectomy was 7.25 dayswhile that for LAH was 4.9. This would suggest that there may be a saving inbed stay and hence cost.

While it appears that hospital stays for LIHR may be shorter than for openrepair, no significant difference is apparent, and, as the open procedurebecomes less complicated, length of stay will decrease.

This survey was unable to provide adequate data for the assessment of the costimplications of LIHR or any other laparoscopic procedure. Only the initiationof prospective Australian studies will determine the cost benefit implications ofthis surgery for the Australian community.

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Conclusions• It appears from the case studies that the current credentialling process

in Australia is flawed and should be reviewed.

• Both Royal Australian College of Obstetricians and Gynaecologists/Australian Gynaecological Endoscopy Society and Royal AustralasianCollege of Surgeons endoscopic groups have introduced guidelines fortraining and credentialling. The implementation of these guidelines islimited by the need to establish hospital credentialling committees andby unresolved legal problems related to protection of the members ofsuch committees.

• The question of medicolegal responsibility of preceptor and traineeremains a contentious and unresolved issue limiting training bypreceptors in many institutions. It is envisaged that the Colleges wouldbe the most appropriate bodies to review this matter and to makerecommendations to their members about how satisfactory trainingand preceptorship can be achieved.

• Since laparoscopic procedures were introduced in Australia, there hasbeen inadequate provision of trained staff apart from surgeons, theatrefacilities, procedures and equipment. These resources are essential forall units assessing or performing new procedures.

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5 Protocol for the assessment ofminimal access surgery

BackgroundAs discussed in the overview, there is increasing recognition among healthprofessionals, administrators, consumers and policy makers that there shouldbe a more systematic approach to the assessment of new and emerging surgicalprocedures which is based on evidence derived from well conducted clinicaltrials and economic evaluation. The case studies highlight the fact that therisks and benefits of laparoscopic procedures were not adequately assessedbefore their introduction into clinical practice. The following protocol has beendeveloped to address the issues raised in this study and to facilitate thesystematic assessment of new laparoscopic procedures.

During the consultation process, the attention of AHTAC was drawn to theexistence of a UK sub-committee which assesses clinical procedures in surgeryand categorises them as established or non-established according to certaincriteria. It may be appropriate to consider the establishment of an expert bodyin Australia to continually assess new surgical techniques before they areaccepted and practised in the general community.

Definition of a ‘new procedure’Defining the point at which an experimental procedure becomes an acceptedstandard of care is difficult. The goal of new procedures is to improve thestandard of care available to consumers. For laparoscopic surgery, this goal isto correct the surgical problem at least as well as the equivalent open procedure,with the benefits of decreased pain, surgical scarring and recovery time.

The popular perception of the development of a new procedure is that a newand viable idea moves in a linear progression from concept, to animal studies,to controlled populations and finally, in the case of a surgical procedure, to theoperating theatre of the general hospital. This linear model implies that onecan make a neat distinction between the phases of research, development andadoption.

The introduction of MAS in Australia has shown that the uncertaintyassociated with a new technology is not necessarily resolved before its intro-duction into practice.

Any new procedure, however promising, that has not had its safety and efficacydemonstrated should be seen as experimental. Such procedures should only beundertaken in the context of appropriate clinical trials, ensuring evaluationbefore diffusion into clinical practice. This should not preclude the availabilityof new techniques to patients, but should ensure that data are available forinformed assessment of each procedure.

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Current ‘assessment’ processesThe introduction of new medical procedures into clinical practice in Australiaoccurs in a variety of ways:

• changes or improvements in existing techniques which lead to wider access;• expansion of the indications for existing procedures; and• technical developments, such as the availability of new pieces of equipment.

Some new techniques are initiated in Australia, but because of Australia’srelative size, the vast majority of new procedures and technologies come fromoverseas. Initial assessment of procedures may occur in Australia or overseas.There is enormous variation in the extent to which new developments havebeen trialed or evaluated overseas before being adopted in Australia.

Traditionally in Australia, the major teaching hospitals have been the primarysite for the introduction and development of new technology and procedures.Teaching hospitals, both public and private, are Australia’s centres ofexcellence and there is a natural link between research and teaching. It isenvisaged that many first phase studies will take place in such institutions.

Introduction of new items to the Medicare Benefits ScheduleNew inclusions on the Medicare Benefits Schedule (MBS) related to minimalaccess surgery are usually based on the recommendation of the professionalmedical and surgical Colleges, national endoscopic societies and the AustralianMedical Association. It is the responsibility of Colleges to have assuredthemselves of the efficacy of the treatment before seeking its inclusion on theschedule. While the Department of Health and Family Services may carry outliterature searches, the Colleges’ advice is usually relied upon. Although thereare currently no set criteria for assessing the data on which this advice isbased, guidelines are available on what the profession should supply.

Comparison with arrangements for introduction of new pharmaceuticalsNew pharmaceuticals are much more rigorously assessed than new surgicalprocedures. First, the drug is assessed in terms of its safety and efficiency asclaimed by the manufacturer. The results of these evaluations are assessedthrough the Australian Drug Evaluation Committee under the auspices of theTherapeutic Goods Administration. The second stage involves detailed costbenefit analysis and a comparative analysis with existing drugs before listingon, and therefore subsidisation by, the Pharmaceutical Benefits Scheme (PBS).

There are fundamental differences in the delivery of pharmaceuticals and newprocedures that preclude simple emulation of the pharmaceutical system.First, there are fewer variables in the delivery of a pharmaceutical comparedwith the adoption of a new surgical technique. While instrumentation anddevices could be assessed in a similar way, surgeons are individuals whosetechniques, training needs and preferences for types of procedures will alwaysvary. Pharmaceutical companies consider participation in clinical trials to benormal business practice. In the case of new procedures, there is no analogoussponsor to undertake or fund development and systematic review of the

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evidence. Health practitioners and governments must work together to fulfilthis role and explore options to improve data collection such as linking publicsubsidisation with assessment of new techniques.

Clinical researchFor the last 50 years, clinical research has been seen as important by themedical profession. Traditionally, judgements about clinical relevance havebeen based largely on expert professional opinion expressed by medicalcolleges, societies or associations. Clinical trials have played a major role inproviding evidence to support these opinions, but the sources of the evidenceand its review and dissemination have been given less attention. The casestudies highlighted many of the problems faced in clinical research.

While a high percentage of surgeons surveyed for the LIHR case study hadparticipated in the audit of herniorrhaphy, surgeons relied heavily on informalpeer discussion to discover the benefits and/or disadvantages of laparoscopicherniorrhaphy. Reasons for the reliance on informal mechanisms for thesharing of experience include:

• the publication of research generally lags 12 to 18 months behind thecompletion of studies;

• the results of studies cannot usually be compared in a systematic mannerdue to variations in the new procedures being assessed as well as differentoutcome measures used;

• poor results are usually not published and this has the effect of skewingdata to give a positive slant on the new procedures; and

• many surgeons ‘try out’ or self evaluate a procedure by trial and error andstop after one, two or more cases because of adverse experience. Of surgeonsin the LIHR case study, 30 per cent were in this category.

Therefore, practitioners and policy makers must rely on limited clinical trialevidence regarding minimal access surgery, supplemented by anecdotal andpossibly skewed published information. Because of the lack of evidence, it issimply not known whether laparoscopic procedures are superior, comparable orinferior to open procedures.

Levels of evidenceIn assessing the strength of the evidence in support of a recommendation, anumber of factors need to be considered. These include the source of evidence(e.g. type of research design), amount of evidence (i.e. numbers and size ofstudies) and the consistency of the evidence (e.g. the homogeneity of theresults from different studies). The strongest evidence is that obtained from asystematic review of all relevant randomised controlled trials. Well designedcontrolled trials without randomisation and cohort or case controlled studiesprovide progressively weaker scientific evidence. Opinions based on clinicalexperience, descriptive studies or reports of expert committees are consideredsubordinate to those based on scientific evidence.

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In terms of the protocol for the assessment of new procedures, the hierarchy ofthe level of evidence scale is necessarily reversed. Lower level studies shouldprecede the higher level studies when assessing new procedures. Gross problemswill be detected in earlier studies and may indicate that the procedure shouldbe abandoned. Higher level studies are used to assess the less obvious risksand benefits in greater numbers of patients. The ultimate aim of the evidencebased approach is to make available all sources of information, including poorresults, at the earliest possible stage in the introduction of new surgicaltechniques. The detection of problems will occur earlier if cases are carefullyrecorded and subject to prospective audit.

Issues surrounding the development of a protocolThe following issues need to be considered during assessment of new surgicaltechniques:

• patient information and consent• training• credentialling• data collection• funding arrangements.

Patient information and consentPractitioners should tell patients:

• about the risks of any procedure, especially those risks that are likely toinfluence patient decisions;

• that they are only able to undergo the new procedure through participatingin clinical trial. When a procedure is experimental, there are specific ethicalguidelines that impose a high duty of disclosure of information to patients; and

• about the degree of certainty, the benefits, risks, and efficiency of the procedure.

This verbal information should be reinforced with information sheets or booklets.

Patients selected for inclusion in a clinical trial should be provided with apatient information sheet with a brief description of the new procedure,alternative treatments and usual hospital procedures, in addition to informedconsent. Introduction of the new procedure, the consent form and the patientinformation sheet should be reviewed and approved by the hospital ethicscommittee.

Training and the role of CollegesThe Royal Australasian College of Obstetricians and Gynaecologists, theGynaecological Endoscopy Society and the Royal Australasian College ofSurgeons have policy documents that specify training guidelines andrecommendations. All practitioners undertaking new procedures should betrained according to the requirements of the appropriate College.

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Practitioners involved in the assessment of new procedures may identify theneed for new skills and additional training in conjunction with the new pro-cedure. Practitioners should include a summary of their technical experiencewith the new technique and any training recommendations. This informationshould be sent to the relevant College with the audit data. The College wouldthen be able to act on the training needs identified through the assessmentprocess at the earliest possible stage.

Credentialling for new proceduresAs discussed earlier, a review of the credentialling process in Australia mayrecommend the expansion of credentialling committees in Australian hospitalsor the establishment of credentialling bodies at state or national level. The roleof these committees could be expanded to include initial approval of proposalsto assess new procedures. The credentialling committee or heads of the relevantdisciplines could then decide whether new procedures require separateprivileging. Separate privileging may be necessary for all new procedures.

Data collectionThe assessment of new procedures requires the cooperative input of manypractitioners. Systematic collection of data held in accessible databases wouldenable practitioners and the relevant Colleges to assess the safety of newprocedures.

For the assessment process to be successful, data collection must include themeasurement of appropriate outcome indicators. Selection of outcomes mustrelate to the objectives and known and possible risks of the procedure beingassessed, and concentrate on areas of uncertainty in the procedure. Subjectivepatient measures should be included, by home visit or phone contact, as manyof the proposed advantages of new laparoscopic procedures are related to thereduction of patient discomfort in comparison with the open procedure.

Introducing a new procedure can have a number of ‘flow on’ effects withinwider health services. The potential effects of the new procedure, includingcost effectiveness, should be considered and discussed in the early phases ofthe assessment process.

Data collection should be carried out under the protection of quality assurancelegislation, which has confidentiality provisions prohibiting the disclosure ofinformation which identifies individual patients or health care providers, andwhich could become known solely as a result of the declared QA activity.

FundingConsiderable resources are needed to carry out well constructed assessments.For example, funding could be sought to cover administrative expensesincurred by a practitioner who has assessed the available evidence andsubmitted a protocol to the credentialling committee and ethics committee of

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his or her hospital. Funding would also be needed by the expert bodiesinvolved in the collation and assessment of the data generated throughout thevarious phases of assessment.

There are two sources of funding for assessment—funding through researchgrant schemes, and public funding through Medicare. A system wherebypayment for procedures was dependent on contributing data to an audit ortrial would ensure maximum participation.

ProtocolThis protocol does not advocate a rigid sequence of assessment, as the keyconcept in the evidence based approach is the assessment of evidence at alllevels of research.

New procedures at the earliest phase of assessment should not be undertakenby practitioners learning laparoscopic techniques, that is, those in the earlystage of their ‘learning curve’. This will help to reduce the confoundingvariable of inexperience with laparoscopy from inherent risks in the newprocedure. The introduction of a procedure at later phases should be facilitatedby appropriate training and supervision and concurrent mandatory reportingof results.

The first phase of an assessment occurs after the initial discovery of theprocedure or its introduction into the Australian health system. Practitionersinterested in assessing the new procedure in the Australian context coulddesign a study protocol for a single series to be undertaken at their hospital.They should initially seek approval from their own credentialling and ethicscommittees. After obtaining approval, patients could be selected for a singleseries study with care taken to ensure that all patients are fully informed andconsent to the procedure. Through the practitioner’s interest and involvementin the initial assessment, the relevant hospital would become a designatedcentre. After completion of the series, the data would be compiled and an auditreport incorporated in a central database accessible to all interestedpractitioners. Within a relatively short time, the Colleges, other practitioners,funding bodies and policy makers would have access to several studiesassessing the new procedure.

It would be appropriate at this stage for an expert body to makerecommendations regarding the next phase in the assessment process.Problems and uncertainties in the new procedure would then need to beexamined in more detail. This could be achieved through multicentre audits,randomised controlled trials, or both.

Data collection measures should be standardised as far as possible to permitcomparison of results. An expert body, for example the NHMRC Clinical TrialsCentre, could develop the multicentre audit or randomised controlled trialprotocol on the basis of first phase results. Training and credentialling

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recommendations made by the relevant Colleges based on their assessment ofthe results could be implemented by practitioners participating in the laterphases of assessment.

Only when the safety and efficacy of the new procedure has been demonstratedshould funding arrangements to undertake procedures outside the clinical trialprocess be made.

First phase or single centre development / testing of newprocedure• Only practitioners with relevant training and experience according to their

College guidelines to undertake new laparoscopic procedures.

• Practitioners develop a protocol for consideration by an expert body whichincludes:

—a summary of the available evidence on efficacy and safety (from results ofanimal studies or studies outside Australia); and

—the methodology which outlines outcome measures.

• Patient information and consent processes are developed and the protocolsubmitted to the appropriate ethics evaluation body for approval.

• Study undertaken according to the protocol.

• The results of the study or studies are reviewed in conjunction with therelevant College.

• A recommendation is made about continuing to assess or discontinuing theprocedure.

Multicentre audit• A multicentre audit will provide greater numbers to evaluate the procedure.

• A research protocol is developed by an expert body. Data collection measuresshould be standardised as far as possible.

• The revised protocol is based on available information including the firstphase study and should be submitted for ethics committee approval.

• Recommendations based on the experiences of initial study to be taken intoaccount.

• Practitioners to adhere to revised protocol, measuring the same outcomes toensure comparability of studies.

• Reimbursement for the procedures will be dependent on undertaking newprocedures according to the protocol and supplying data.

• Patients are provided with adequate information and have given theirinformed consent to the procedure and the involvement in the trial.

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• The results of the multicentre audit are made available/published.

• The relevant body makes recommendations based on the conclusions of themulticentre audit. The procedure may be discontinued, recommended assuitable for widespread diffusion or, alternatively, further studies includingrandomised controlled trials may be considered appropriate.

Randomised controlled trialA randomised controlled trial (RCT) is considered to be the gold standard ofproof of the safety and efficacy of a new procedure compared with current bestpractice.

• The RCT is designed to clarify areas of uncertainty highlighted in theearlier phases. RCTs are to be used where the results of earlier phases donot preclude the continuation of the procedure or where the audit datasuggest advantages for the procedure. Where audit data clearly demonstratesignificant advantages for the procedure, it may be considered unethical toconduct an RCT. In cases where an RCT is considered inappropriate, arationale should be given.

• An expert body develops an RCT protocol on the basis of the results from theprevious studies.

• The revised protocol is submitted for ethics committee approval.

• Recommendations based on the experience of the multicentre audit to betaken into account.

• Reimbursement for the procedures will be dependent on undertaking newprocedures according to the protocol and supplying data.

• Patients are provided with adequate information and have given theirinformed consent to the procedure and involvement in the trial.

• The results of the RCT are reviewed by the relevant College. The resultsand the recommendations of the College regarding the appropriate use ofthe procedure are made widely available.

Confirmation of efficacy/safety profile• The consideration of the evidence at all levels of assessment is undertaken

by an expert body, in conjunction with the relevant College.

• A recommendation is made regarding the safety and efficiency of the newprocedure.

• Funding is available outside the trial process.

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Literature review—LIHRThis review describes the different laparoscopic techniques used, reporting ofsmall series of LIHR, and the results of the four published randomisedcontrolled trials comparing the laparoscopic technique with conventionalrepairs. A number of other investigators are presently undertaking randomisedcontrolled clinical trials, the results of which are not yet published. Because ofthe variable reporting of results and very limited follow-up, it is difficult toevaluate properly the procedure from the published literature. In particular,the lack of any long-term follow-up results precludes any true assessment ofrecurrence rates.

Historical development of herniorrhaphyWhile an extensive review of conventional methods of inguinal hernia repair isbeyond the scope of this document, a brief introduction to the different methodsof managing hernial defects will place the development of laparoscopic herniarepair in perspective.

Traditional methods of inguinal hernia repairThe traditional operation employs the principles of high ligation of the sac andreinforcement of the posterior inguinal floor as originally described by Bassini(1887). In an attempt to further reduce recurrence rates and complications,many modifications of Bassini’s repair have been described, notably by McVay,Halsted, and the Shouldice Clinic (Halsted 1893; McVay 1948; Shearburn & Myers 1969).These techniques share the principles of isolation and excision of the hernialsac with reconstruction and reinforcement of the posterior wall of the inguinalcanal.

In 1988, Rutledge published an excellent description of the McVay technique(Cooper’s ligament repair) together with results, collected over a 25 yearperiod, of procedures carried out on 942 patients (Rutledge 1988). He observed arecurrence rate of 1.9 per cent for primary repairs after an average follow-up ofnine years. The Shouldice hernioplasty derives its name from the surgeon andhospital of the same name in Toronto, Canada and had evolved to its presentform by 1950. Glassow reported on 12 548 repairs performed at the ShouldiceClinic between 1954 and 1974, and cited a recurrence rate of only 1.1 per centfor primary repairs (Glassow 1986). The same publication included a summary ofseven other series all using the same technique with at least a 10 year follow-up, and reported a mean recurrence rate of 1.5 per cent from 11 809 patients.A large collected review of inguinal hernias repaired by the Bassini methodand its modifications reported recurrence rates of 1 to 7 per cent for indirecthernias, 4 to 10 per cent for direct hernias and 5 to 35 per cent for recurrenthernias (Condon & Nyhus 1989).

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Lichtenstein and colleagues from the Cedars-Sinai Medical Centre in LosAngeles contend that all of the above repairs share the common disadvantageof tension on the suture line (Lichtenstein et al. 1989). They believe that this is theeventual cause of post-operative disruption and the prime cause of herniarecurrence. They have popularised the concept of a tension free open anterioringuinal hernia repair (Lichtenstein et al. 1989; Shulman et al. 1992a; Amid et al. 1993).Prosthetic mesh is used in their standard repair and is sutured to the inguinalligament and internal oblique muscle. Using this approach, the usualapproximation of aponeurotic tissue under tension is avoided. Furthermore,their technique is usually performed under local anaesthesia. They havepublished impressive results including low recurrence rates, few complicationsand early return to regular activity. The use of polypropylene mesh for thistechnique has been shown to be safe and effective for hernia repair (Capozzi &

Cherry 1988). Lichtenstein reported a recurrence rate of 0.7 per cent in 6 321cases, with a mean follow-up period of eight years (Lichtenstein 1987). Lichtensteinet al. reported 1 000 consecutive cases followed for one to five years, without asingle recurrence or prosthetic infection (Lichtenstein et al. 1989). In a recent reviewof 3 019 primary inguinal hernia repairs using prosthetic mesh, the overallrecurrence rate was 0.2 per cent (Shulman et al. 1992b).

Despite the fact that these are all accepted techniques of open anterioringuinal hernia repair, significant complications have been reported, post-operative pain and disability are well documented and recurrence rates up to10 per cent, outside of specialist centres, can be expected (Wantz 1984). Thecreation of tension, common to many repairs, is felt to be the cause of many ofthese problems.

The open preperitoneal approach to hernia repair was originally described byCheatle in 1920. Modifications of this technique using mesh have beenreported by Nyhus et al. (1988), Rignault (1986), Stoppa (1989) and others. Thisapproach has gained widespread use, particularly for recurrent herniasbecause it circumvents scar tissue from previous surgery, and for femoral andcomplicated hernias (e.g. sliding and incarcerated inguinal hernias) because ofthe greater visibility of the region it affords in comparison to the anteriorapproach. Excellent results, with recurrence rates as low as 1.4 per cent, havebeen reported (Nyhus et al. 1988; Stoppa 1989).

Excellent results with recurrence rates below 1 per cent have been reportedfrom specialist centres with open techniques, with and without a prosthesis,often on a day surgery basis. However, in England and Wales, 10 per cent ofthe inguinal hernias repaired annually are recurrences and a study of eightSwedish hospitals showed that 17 per cent of the hernia operations were forrecurrence (Nilsson et al. 1993), suggesting a much higher rate outside specialistcentres than reported in the literature. The average recurrence rate isprobably about 10 per cent after primary hernia repair and more than20 per cent after repair of recurrent hernias (Rutkow & Robbins 1993; RACS 1993).

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It must be acknowledged that conventional open herniorrhaphy methods arewell established and proven to be effective with low morbidity and mortality.Most can be performed under local anaesthetic with or without sedation andthe patients go home the same day (Lichtenstein & Shulman 1986). Return to workwill vary with the amount of dissection required, the nature of the patient’sjob, the extent of disability coverage and other factors. It may take four to sixweeks before full activity can be comfortably resumed after traditional repairs.The economic impact of millions of days of disability is enormous.

Since 1990, laparoscopic techniques for hernia repair have been introduced. Itwas hoped that laparoscopic repair would combine the advantages of minimallyinvasive surgery (i.e. diminished post-operative pain and early return tonormal activities or work) with an effective repair as evidenced by a lowrecurrence rate. However, some techniques have already been abandoned bytheir originators due to unacceptably high complication or recurrence ratesand the initial enthusiasm is beginning to fade due to reports of serious nerveinjuries (Kraus 1993; Eubanks et al. 1993), post-operative bowel obstruction and highrecurrence rates in some centres.

Laparoscopic methods of inguinal hernia repairThe first human laparoscopic herniorrhaphy was performed by Ger in 1982 byintra-abdominal stapling of the neck of the sac (Ger 1982). However, there waslittle interest in this procedure until the introduction of laparoscopic cholecyst-ectomy. Bogojavlensky presented laparoscopic herniorrhaphy to the AmericanAssociation of Gynaecological Laparoscopists in 1989 (cited in Cornell & Kerlakian

1994). By 1991, laparoscopic herniorrhaphy was thought to be the ‘nextrevolution in minimal invasive surgery’ and enthusiasts predicted that abouthalf all hernia operations would be done laparoscopically by 1995. However,others predicted that the laparoscopic hernia repair would be harder to ‘sell’because of the variety of techniques employed, in contrast to laparoscopiccholecystectomy where there is a single approach. A variety of techniques forlaparoscopic herniorrhaphy have been introduced with varying degrees ofsuccess, although rapid improvement of techniques has advanced the prospectthat laparoscopic approaches will become established alternatives toconventional herniorrhaphy.

Methods of laparoscopic inguinal hernia repairUnlike laparoscopic cholecystectomy where the majority of surgeons use asimilar technique, in laparoscopic hernia repair the defect is approached fromthe posterior aspect, whether intraperitoneally or retroperitoneally. AlthoughLIHR is soundly based in theory, its practical application has proved difficult.As yet there is no consensus on which is the best procedure for laparoscopichernia repair. However, three principal methods form the basis of most currentlaparoscopic hernia repairs.

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• The simplest and fastest to perform is the intraperitoneal onlay meshtechnique (IPOM) but this is also the most controversial procedure. Afterlaparoscopic evaluation of the hernia defect, a large piece of synthetic meshis placed and fixed directly onto the peritoneum covering the direct, indirectand femoral hernia spaces. Many feel that this method should be consideredinvestigational, since long-term results and the potential for problemsrelated to the presence of exposed mesh within the peritoneal cavity are yetto be evaluated.

• The most popular current approach is the transabdominal preperitonealprosthetic repair (TAPP) which is a modification of the preperitoneal openhernia repair popularised by Stoppa. The technique involves laparoscopicaccess to the peritoneal cavity, incision of the peritoneum transversely abovethe hernia defect to access the preperitoneal plane, and subsequent creationof a preperitoneal space and disposition of the hernial sac. A synthetic meshis then placed over the hernial defect in the preperitoneal plane and securedby either sutures or staples. The peritoneal flap is then re-approximatedover the mesh to create a barrier between the mesh and the bowel (Nguyen et

al. 1994).

• The third technique, referred to in this review as the total extraperitonealapproach (TEP), was first described by Ferzli et al. in 1992 and popularisedby McKernan. It avoids entrance into the abdominal cavity by using thespace between the peritoneum and the transversalis fascia to access theinguinal region (Nguyen et al. 1994). A small incision is made below the umbilic-us, and the preperitoneal space is created by tunnelling, using either bluntinstruments, aquadissection or, more recently, a specially developed balloondissection device. The indirect hernial sac is opened, ligated and excised. Alarge piece of polypropylene mesh is placed over the defect and fixed withstaples. Most authors consider this approach to be the most difficult of thethree techniques to learn but it combines the advantages of the openpreperitoneal technique with those of minimal access surgery.

For more detailed accounts of each technique see Hanafy (1993).

Advantages and disadvantagesProponents of laparoscopic herniorrhaphy argue that the procedure has con-siderable advantages over open hernia repair. The potential major advantagesof laparoscopic repair of a groin hernia are secondary to the creation of smallpuncture wounds instead of a seven to ten centimetre inguinal incision and theneed for minimal dissection. The small puncture sites are said to give animproved cosmetic result, potentially less post-operative pain, faster recoverytime and earlier return to work (Fitzgibbons et al. 1995). The inguinal canal is notopened, reducing the risk of injury to the structures within the spermatic cord,including the ilioinguinal and genitofemoral nerves, and ischaemic orchitis.Inguinal wound complications, which can predispose to hernia recurrence,might be eliminated. The use of a laparoscope also allows for the performanceof simultaneous diagnostic or therapeutic laparoscopy (Dion & Morin 1992), easier

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repair of recurrent hernia, and the ability to diagnose and treat bilateralhernias during the same operative procedure. An unsuspected contralateralhernia is apparent in 16 per cent of patients at laparoscopy, and coincidentrepair may not increase morbidity (Sailors et al. 1993). Other technical advantagesare said to include the ability to achieve the highest possible ligation of theperitoneal sac, and the fact that the stapled preperitoneal hernia repair isfurther supported by the increased intra-abdominal pressure holding the meshto the fascia, thus reducing the risk of mesh migration.

A major disadvantage of laparoscopic hernia repair is that general anaesthesia,with its associated complications, is usually obligatory. However, in countriessuch as Australia, this has minimal impact, since most groin hernias repairedconventionally use general anaesthesia. The patient is also exposed to theinherent risks of laparoscopic techniques such as gas embolism, vascularinjury or organ damage (Fitzgibbons et al. 1994). Extensive experience with gynae-cological laparoscopy indicates that major complications due to laparoscopymay be expected in 1.5 to 2 per cent of patients, with a mortality rate of 0.005to 0.24 per cent (Hirsch & Hailey 1995). These figures imply that the universaladoption of laparoscopic hernia repair in Australia could result in up to five orsix additional deaths per year due to laparoscopy alone. Other potential risksinclude prosthesis-associated infection, prosthetic-associated adhesions,intestinal obstruction, the long-term possibility of adhesions to the site wherethe peritoneum has been breached, erosion of prosthetic material into adjacentorgans and the risk of long-term recurrence.

In laparoscopic biliary surgery, gastric and colon surgery, the anatomy as seenthrough the laparoscope differs little from that seen in the open traditionalprocedures. In contrast, LIHR involves an entirely different approach to thegroin, which is unfamiliar to most surgeons. Although some open repairsinvolve a preperitoneal approach, most surgeons are only familiar with theanterior approach and are not easily able to identify the important landmarksfrom inside the abdomen. Various ligamentous structures, such as the trans-versus abdominus arch, Cooper’s ligament and the iliopubic tract need to beproperly identified in order to adequately secure the prosthetic mesh. Withoutproper knowledge of their location, the vas deferens, external iliac, testicularand inferior epigastric vessels, as well as the femoral and lateral cutaneousnerve of the thigh can be easily injured. The potential for catastrophic injury tomajor vascular structures, has led the area between the vas deferens and thetesticular vessels to be named the ‘triangle of doom’—between these structures,covered by peritoneum and transversalis fascia, lie the external iliac vessels.

Opponents of LIHR also point to the greater expense associated withlaparoscopic surgery because of specialised equipment, the use of prostheticmaterials and increased operating time as compared with the conventionalrepair (Fitzgibbons et al. 1994). However it has been argued that the additionalcosts of the procedure are offset by the advantages of quicker recovery andreturn to work, thus reducing individual and societal costs.

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Complications of laparoscopic surgeryComplications of the operation are related both to the surgical procedure ingeneral and more specifically to the laparoscopic technique. A number ofcomplications related to laparoscopic hernia repair have been reported(MacFayden et al. 1993). Some of them are well known from open surgery, butcomplications directly related to the laparoscopic procedure previously notexperienced with an open repair have been reported, including adhesion of thebowel to the mesh patch, causing intestinal obstruction (Hendrickse & Evans 1993)and herniation through the peritoneal closure causing small bowel obstruction.

The mortality rate as a result of laparoscopy has been reported to range from0.03 to 0.49 per cent (Kane & Krejs 1984). Fatal carbon dioxide embolism com-plicating attempted laparoscopic cholecystectomy has been reported (Lantz &

Smith 1994). Laparoscopic cholecystectomy is associated with significanthypercoagulability and dilatation of the veins of the leg. Despite being a‘minimally invasive procedure’ there remains a definite risk of developing post-operative thromboembolism that could extend beyond hospital discharge.

Neuralgia and nerve entrapmentPersistent pain (neuralgia) and a burning sensation (dysesthesia) in the groinafter laparoscopic inguinal hernia repair is a common, usually transient,complication. These symptoms, produced by the entrapment of the genitalbranch of the genitofemoral nerve, the ilioinguinal nerve, or the iliohypogastricnerve, occur in an estimated 1 to 2 per cent of conventional herniorrhaphies.

Initially it was predicted that laparoscopic inguinal hernia repair would reducethe number of nerve entrapments because the ilioinguinal and iliohypogastricnerves are in a plane superficial to the preperitoneal dissection. However, asthe technique has evolved the use of larger meshes has demanded moredissection and fixation of the prosthesis with stapling devices. This introducespotential for injury to all branches of the lumbar plexus, notably the lateralcutaneous nerve of the thigh and the femoral branch of the genitofemoralnerve. Injury to all these nerves, with the exception of the obturator nerve, hasbeen reported (Keating & Morgan 1993; Eubanks et al. 1993; Kraus 1993). Generally, theentrapments are self limiting but chronic disability requiring surgical inter-vention has occurred.

Anatomic studies have been undertaken, many using cadavers, to delineatemore clearly the anatomy of these nerves as they are relevant to laparoscopicpreperitoneal inguinal hernia dissection. Safer dissection and optimal stapleplacement, avoiding the anatomic area described as the ‘trapezoid of disaster’by Seid, should ultimately lead to a decrease in injury to these nerves.Avoidance of indirect compression effects due to retractors, stirrups or throughexcessive force when stapling, should further minimalise the risk of nerveentrapment (Seid & Amos 1994). In a series of 145 laparoscopic herniorrhaphypatients, three patients (1.4 per cent) developed nerve entrapments. Allresolved spontaneously in six to eight weeks after being treated with localinjections (Seid & Amos 1994).

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HerniationHerniation after laparoscopy is rare. Trocar hernias have been reportedfollowing laparoscopic hernia repair.

Small bowel obstructionSmall bowel herniation through a lateral port site and small bowel trappedbeneath a flap of peritoneum (Milkins et al. 1993; Sailors et al. 1993) have all beendescribed. Adhesion to mesh is more likely following the TAPP intraperitonealonlay techniques.

Major vascular injuryMajor vascular injury directly related to insertion of the pneumoperitoneumneedle or trocar in laparoscopic procedures are rare but potentially fatal. How-ever, the true incidence of major vascular injury during laparoscopy is unknownand probably underreported. From the 24 cases reported in the literature,there were three deaths. Most patients were woman of childbearing age under-going pelvic laparoscopy. None of these involved an inguinal hernia repair(Nordestgaard et al. 1995). The vascular injuries were caused by the pneumoperi-toneum needle in twelve cases, by the trocar in seven, and during sharp dis-section in three—the cause was not mentioned in two cases. One case wassubsequent to an apparently uneventful laparoscopic inguinal hernia repair.Transection of the inferior epigastric artery led to the formation of a largehaematoma in the left anterior abdominal wall and profound post-operativehypotension. This resulted in an ischaemic cerebral accident requiring a pro-longed stay in the rehabilitation unit to regain independence. Immediaterecognition with conversion to an open procedure and appropriate vascularsurgery is required to minimise morbidity and mortality.

Other reported complications include colovesical fistula secondary to meshinfection (Gray et al. 1994), pharyngeal emphysema with airway obstruction (Chien

& Soifer 1995), small bowel obstruction (Spier et al. 1993), small bowel obstruction dueto an incarcerated Richter’s hernia through the trocar site and bladder injury.

Placement of the mesh via an intra-abdominal approach, creates the risk ofintraperitoneal adhesions and of post-operative bowel obstruction due to smallbowel loops adhering to the mesh site. For the transperitoneal approach tolaparoscopic hernia repair to be an acceptable procedure, the risk of significantadhesions has to be shown to be negligible. A recent experimental study wascarried out on 21 pigs to ascertain whether the transperitoneal approachincited significant adhesions at sites where the peritoneum had been breached(Eller et al. 1994). The pigs served as their own control with a laparoscopic herniarepair being performed on the left and a sham procedure on the right. Laparo-scopy examination six weeks post-operatively showed no discernible intra-peritoneal adhesions at the trocar insertion sites. Although adhesions werepresent in the area of the hernia repair, these were limited to contiguousstructures which had been used in the closure of the peritoneum. There wereno bowel-to-bowel adhesions or adhesions involving small bowel and theauthors concluded that transperitoneal laparoscopic herniorrhaphy does notincite significant adhesions.

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Cost considerationsGiven the increasing cost pressures on most health systems, the economicimpact of laparoscopic surgery is an important consideration in its accepta-bility in surgical practice. There is much conjecture as to the potential hugesavings of laparoscopic procedures in general. Laparoscopic cholecystectomyappears to have greatly reduced the hospital length of stay for cholecystectomy.However, commentators have argued that the additional costs incurred byinvestigations and specialised equipment combined with hidden costs arisingfrom reductions in the threshold for surgical intervention and an increase inpopulation demand (Orlando et al. 1993), have not resulted in overall savings.

There is a well recognised need to examine the costs of laparoscopic surgeryfrom different perspectives (Rutkow 1992). The costs of the procedure includethose of directly related hospital and facility services, and those incurredthrough loss of productivity related to disability or time off work. Whenevaluating the impact of LIHR on government health and social securitybudgets, the savings in sick pay as well as differences in hospital costs need tobe taken into account.

Rutkow (1992) states that because patients are returning to normal activitieswithin 48 to 72 hours of a conventional open technique, and that laparoscopicrepair increases facility costs, there is no justification for repair usinglaparoscopic techniques.

Studies by Deloitte Touche Tohmatsu International in 1993 and 1994 reportedon the cost impact of laparoscopic surgery in the United States and threeEuropean countries respectively. Laparoscopic inguinal herniorrhaphy was oneof two laparoscopic procedures examined in detail and compared to thetraditional open procedure. The studies involved nine USA hospitals and sixEuropean hospitals respectively. The hospitals varied considerably in size andrepresented a broad range of provider settings. The studies revealed widevariations in clinical practices and costs between European countries, andbetween Europe and the USA and highlighted considerable potential for costreduction in both laparoscopic and open cases if ‘best practices’ (defined as themost efficient staffing levels, operating times, lengths of hospital stay andother treatment characteristics currently practised at study hospitals) areadopted. Despite widely divergent purchasing and reprocessing approachestaken by the hospitals included in the study, laparoscopic instrumentsaccounted for a relatively small proportion of total case costs. The authors feltthat there was more scope for cost reduction from improving operating timesand lengths of stay to ‘best practice’ levels than from reducing instrumentcosts. Laparoscopic inguinal hernia repair increased hospital costs in mosthospitals studied. However, the difference may narrow in the future ashospitals gain more experience with LIHR. When short-term disability costsare considered, the differences between the costs of open and laparoscopichernia repair narrow considerably. The study revealed that the total andvariable costs for laparoscopic herniorrhaphy in the USA were higher than

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those for the open approach and never likely to be less expensive due to thefact that open herniorrhaphy can be performed as a day procedure. While thestudy speculated on cost savings on a broader perspective this was notexamined.

Not surprisingly, due to the fact that the literature is generally written interms of surgical technique, assessment of the literature does not address costissues clearly. Cost implications can be inferred from the length of stay, andreturn to normal activities. Outcome variables, such as disability or pain, arevery nebulous and often subjective (Wexner 1993). In many ways the flow-on costsof surgery cannot be measured accurately between studies. Return to normalactivities is often reported rather than return to work. Paid work itself is abiased measure. The literature focuses on major life threatening complications.However, minor complications also have cost implications as they impedepatient return to work and comfort levels.

Few authors have performed cost analysis and no statistically significantadvantage for laparoscopic inguinal repair is yet apparent from these studies.Randomised studies which may determine the durability of the operation,procedural costs and the overall savings are now in progress. Many feel thatcomparison should be with the mesh repair without tension done under localanaesthetic.

Australian contextIn his editorial on laparoscopic hernia repair, Hugh (1993) reported that, at the‘Hernia 2000’ symposium held in Sydney in March 1993, over 200 surgeons(mostly enthusiastic laparoscopists) were asked whether as patients theywould prefer to be randomly allocated to an open or laparoscopic arm of ahernia trial. Forty-five per cent indicated that they would hope to be allocatedto an open repair. Concern was raised at the high incidence of neurologicalproblems presented at the symposium and the number of mesh relatedintestinal obstructions encountered following LIHR. Many surgeons indicatedthey would adopt a ‘wait and see’ policy towards LIHR. Hugh expressed theneed for randomised prospective trials of open versus laparoscopic methods.

One notable difference between American and Australian surgical treatment ofherniorrhaphy is the practice of day surgery outpatient procedures. In Australia,day surgery herniorrhaphy is not routine. Only Maddern et al. (1994) haveassessed the procedure in terms of day surgery.

Assessment of the procedureThe advantages of laparoscopic cholecystectomy over conventional gallbladdersurgery were obvious early in the evolution of this procedure and it is nowaccepted as standard for symptomatic gallstones. However there remainsconsiderable concern that laparoscopic inguinal hernia repair may entersurgical practice without proper evaluation (Macintyre 1992; Rutkow 1992). The RoyalCollege of Surgeons in England has recommended that appropriate studies toassess the new technique be conducted.

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Late recurrence after herniorrhaphy delays evaluation of techniques forseveral years. Given the low recurrence rates with open herniorrhaphy, theassessment of laparoscopic herniorrhaphy must include other outcome measureswhich demonstrate an advantage over open procedures. These measuresinclude the length of hospital stay and time off work (Paget 1994), pain levelassessments and cost. The reporting of minor complications is important toestablish patient acceptability and comfort with the procedure (Tetik et al. 1994).Many of the outcome measures used to assess laparoscopic herniorrhaphy arenebulous, with potential for bias in reporting (Wexner 1993). These difficulties canbe overcome to some extent through randomised prospective trials where thesame outcome measures are used on both laparoscopic and open procedures.

Much of the published literature is from the US and largely made up ofobservational reports and small, uncontrolled, single series, making meaning-ful evaluation of results difficult. Several series reporting a low recurrence ratehave been flawed in length of follow-up and/or the means of assessment. Whilethe majority of recurrences occur within five years of a procedure, approximately20 per cent recur between 15 and 25 years after the repair. Individual examina-tion of each patient by an independent medical practitioner at regular intervalsremains the only adequate means of assessment of a series of hernia repairs.‘Return to work’ remains an important outcome measure in terms of patientsatisfaction and societal costs but is difficult to measure as it may vary with apatient’s motivation and disability coverage as much as with surgicalmorbidity (Wexner 1993).

Case selectionAlthough selection techniques may heavily bias patient results and return towork patterns, much of the literature does not outline the method or criteriaused for patient selection. Some authors stated that they selected consecutivecases (Felix & Michas 1993; Kavic 1993; Geis et al. 1993) while Wheeler (1993) stated thatcareful initial selection of patients was important, and chose thin people withsmall hernias who were enthusiastic about the laparoscopic approach. In moststudies, patients were excluded if they were considered unsuitable for generalanaesthesia or laparoscopic repair. Previous abdominal surgery was not anabsolute exclusion and included inguinal hernia repair, appendectomy,laparotomy for various conditions, umbilical hernia repair and vasectomy.

ComplicationsThe studies are not consistent in listing complications as major or minor, andthere is probably an element of under-reporting. The higher complication ratesof some surgeons may be the result of diligent reporting practices.

Major complications include any symptom that has become severe enough tonecessitate overnight stay i.e. severe nausea and vomiting, urinary retention,any complication requiring repeat surgery and any condition with lastingsymptoms that result in delay in return to work or normal activities. Thefollowing are always considered major complications: cut vessels; bowel and

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bladder injury; adhesions; trocar hernias; scrotal haematoma not resolvingwithin two weeks; severe neuralgia lasting more than two weeks; pubicosteitis; and hypercarbia.

Minor complications include: port site infection; haematoma; seroma; bruising;neuralgia lasting two weeks or less; and constipation. Where the authors donot define a time frame for transient seroma or neuralgia these have beenassessed as minor.

Evidence obtained from non-randomised single group studiesMany small individual studies on the outcome of laparoscopic hernia repairhave been reported, largely in the American literature. The evidence obtainedfrom these small single group studies in relation to the four major laparoscopicapproaches used is detailed below.

Plug and patchThe plug and patch procedure provides an interesting example of an earlyapproach that excited some interest, but following further investigation provedto be plagued by high recurrence rates, and was then abandoned. Commentatorsrecommend avoidance of this technique (Dion 1993; Arregui et al. 1993).

Schultz et al. (1989) and Corbitt (1991) described the plug and patch techniquefor LIHR, and the latter included high ligation of the hernia sac. Theseinvolved placing a polypropylene mesh plug into the inguinal canal but notbeyond the external ring. The patch was then placed over the hernia defect.Recurrence rates after two years of follow-up were excessively high (greaterthan 25 per cent) and both authors progressed to a transabdominal preperi-toneal approach. The technique consisted of placing a roll of mesh into thehernia and a mesh patch over the hernia defect (Corbitt 1991).

This technique was plagued by high recurrence rates of 15 and 18 per cent(Arregui et al. 1993), and up to 22 per cent (Tetik et al. 1994). The plug was oftennoticeable well after surgery and occasionally slipped out of place. Sailors et al.(1993) had to remove two rolls from the inguinal canal at 20 and 28 weeks postsurgery while 33 per cent of patients had palpable Marlex plugs. Proponents ofthe approach moved on to other procedures, such as the transabdominalpreperitoneal (Voeller), preperitoneal (Schultz and Corbitt) and mushroomplug (Hawasli).

Transabdominal preperitoneal prosthetic repair (TAPP)This is the most documented procedure in the literature and is reportedlyeasier to learn than the total extraperitoneal approach (Corbitt 1991, Ferzli et al.

1992; McKernan & Laws 1993; Philips et al. 1993). Potential drawbacks of the procedureare that extensive dissection is required to create the preperitoneal space andthis can cause damage to the vas deferens or nerves. There is also thepossibility of haematoma formation. A small but inherent risk of complicationsassociated with the transabdominal approach due to injury of a viscus oradhesion formation also exists.

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Major intra-operative complications associated with this technique includebleeding from the inferior epigastric artery (Felix & Michas 1993), bladderperforation (Wheeler 1993), and bowel injury (Felix et al. 1994a). Major post-operativecomplications have included small bowel obstruction (Felix et al. 1994a), testicularpain, neuralgia, urinary retention requiring TURP (Kavic 1993), scrotal haema-toma, epididymitis (Hawasli 1992), chronic groin pain, and port site hernia (Geis et

al. 1993; Milkins et al. 1993). Felix et al. (1994b) state that complications reduce asmore experience is gained.

Milkins et al. (1993) repaired laparoscopically 409 hernias using a transabdominalpreperitoneal mesh repair. Of these 409 hernias, 50 were bilateral and 41recurrent. In all, 56 complications were noted in 54 patients (15 per cent)involving 53 repairs (12.9 per cent). Most of these were minor, and includedseromas (23), haematoma of the cord (one), cubital fossa haematoma at an i.v.insertion site (one), testicular pain (nine) (2.2 per cent) and swelling (one), portsite inflammation (three), pubic tubercle osteitis (five), and meralgia paraesth-etica (six). Pubic tubercle osteitis and meralgia paraesthetica were listed asminor complications, with two of the patients experiencing the formerrequiring local steroid injections and the rest resolving spontaneously (no timelimit was given). Major complications were: the development of urinaryretention in five patients (1.4 per cent) with two requiring prostatectomy, andtwo small bowel obstructions—one secondary to a Richter’s hernia at a lateralport site, neither requiring bowel resection. One patient developed an infectedmesh which was removed four months after the original operation.

Many surgeons report discharging patients on the day of their operation(Hawasli 1992; Felix & Michas 1993; Geis et al. 1993; Wheeler 1993; Felix et al. 1994a). Kieterakuset al. (1994) report that 90 to 100 per cent of transabdominal approaches aredone on an outpatient basis. Milkins reported 39 day case procedures. Of theinpatients, 299 (93.4 per cent) stayed overnight. The longest lengths of staywere reported by Paget (1994; 2.5 days) and Milkins et al. (1993; six days).

Only short-term follow-up rates are presently available. Surgeons have reportedrecurrence rates ranging from nil in six to 12 months (Wheeler 1993), nil in one to21 months (Dion 1993), three in up to 13 months (median seven; 0.75 per cent)(Milkins et al. 1993), Newman et al. one (0.98 per cent)(1993).

Surgeons have reported return to work in different ways. The shortest timeframe reported was three days (Kavic 1993). However, this was at the lower levelof a range of three to 28 days. Several studies reported a mean of seven days,(Felix et al. 93; 94a; 94b). The longest average return to work reported was a meanof 13.4 days (Paget 1994).

Pain was mentioned and discussed in most studies with the general consensusbeing that pain is less in the laparoscopic approach, although this is rarelymeasured. Paget measured pain through a survey questionnaire. His resultsendorse the other studies’ general perceptions that 79 per cent of patientsexperience only low levels of pain.

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Total extraperitoneal mesh approach (TEP)Due to concerns about potential early and late complications associated withentering the abdominal cavity, many surgeons have adopted a totally extra-peritoneal approach (TEP). The recent development of a simple balloon deviceis claimed to facilitate rapid and bloodless dissection of the extraperitonealspace (Kieturakis et al. 1994) with a subsequent reduction in operating time.Kieturakis et al. (1994) reported a series of 150 hernia repairs using a balloondissection facilitated laparoscopic extraperitoneal technique. All were done asoutpatient procedures and approximately 30 per cent were performed success-fully under regional anaesthesia. Venous stasis, cardiopulmonary haemodynamicchanges and hypercarbia are claimed to be avoided in the extraperitonealapproach (Beebe et al. 1993), although this statement has not been corroborated inother publications. By placing the mesh extraperitoneally, there is probablylittle long-term risk of adhesional small bowel obstruction. The technique allowsa clear view of the posterior inguinal anatomy and the hernial defect, and it issuggested as an ideal approach for recurrent hernias which are often difficultto repair by an open procedure (Cable et al. 1994).

Most studies report only minor complications with rates ranging from 2.6 to17.6 per cent. There has been one reported case of orchitis lasting four weeksbut without subsequent atrophy (McKernan 1993). Major complications have beenrare, occurring in three of the six series reviewed. These included bleeding dueto severance of the inferior epigastric vessel (McKernan 1993), and two cases ofpersistent neuropathy relieved by subsequent removal of staples (Kieturakis et al.

1994; Begin 1993).

In one series, five patients required conversion; two patients to an openprocedure and three to a laparoscopic transabdominal preperitoneal approach.All conversions were secondary to disruption of the peritoneum (Ferzli et al. 1992).Kieturakis also reported five conversions, all to an open procedure and all dueto technical difficulties. Three of these were due to loss of the extraperitonealspace secondary to a breach in the peritoneum, one was caused by failure oflaparoscopic equipment. In one patient, surgeons elected to do an open approachdue to the presence of a large irreducible indirect sac.

Reported recurrence rates with the TEP technique are low (0 to 2 per cent)with four studies reporting no recurrences. However the long-term follow-upperiod for all studies is short with a maximum average follow-up of only 12months (range six to 22 months). The method of follow-up is also flawed andoften through mail or phone correspondence only (Kieturakis et al. 1994).

Post-operative pain, although discussed in all series, has not been consistentlymeasured. Begin et al. (1993) evaluated the intensity of the post-operative painon a scale from nought to ten. The mean, for 125 patients undergoing the TEPprocedure was 2.5 (range 0.5 to 6). Seventy-five per cent of patients did notrequire analgesics following discharge. Patients were also asked to rate theresults of the operation; 39 patients considered the results to be good and 110considered them to be excellent (a total of 96 per cent good or excellent

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results). Kieturakis et al. (1994) reported that 52 per cent of patients reportedminimal or no pain in the immediate post-operative period, with 96 per centreporting minimal discomfort after one week. Cable et al. (1994) report theprocedure to have been very well tolerated by all patients. Several studiesreport that patients who had contralateral hernias repaired previously via aconventional, open method were far more satisfied overall with thelaparoscopic repair.

Intraperitoneal onlay mesh (IPOM)Toy and Smoot were one of the first groups of surgeons to perform theintraperitoneal onlay mesh technique initially on a group of ten patients (Toy &

Smoot 1991). This procedure involved high ligation and transection of indirecthernia sacs, direct sacs were left in situ. An endopatch spreader (Nanticoke,Cabot Medical) facilitated the introduction of an expanded polytetrafluorethylene (ePTFE) soft tissue patch which was placed over the herniadefect and secured by staples. There were no complications, minimal post-operative pain and most patients were able to return to full activity by post-operative day two. In a follow-up article, the authors reported the clinicalresults of a larger series of 83 hernia repairs, with all the procedures done asoutpatients (Toy & Smoot 1992). They also described a number of modifications totheir technique. The sole major complication, injury to the bladder, requiredconversion to an open procedure. The two reported recurrences were ascribedto the learning curve of the new technique.

The onlay technique is easy to learn and more quickly performed than theTAPP procedure because preperitoneal dissection is not carried out. However,small preperitoneal hernias may be missed. The major concern with the IPOMtechnique is that the long-term effects of placing a prosthetic material directlyin contact with the abdominal organs are unknown and thus the risk of adhesionsand the potential for erosion into the bowel greatly limit this technique.

Attwood et al. (1994) examined the laparoscopic placement of a polypropylenemesh in a porcine model (n=15) comparing intraperitoneal (IPOM) versusextraperitoneal insertion (TAPP). Both methods of laparoscopic mesh place-ment were associated with a small incidence of adhesion formation (P=0.19,Fisher’s exact test). The adhesions comprised fibrous peritoneal bands to loopsof small intestine. Durstein-Decker et al. (1994) also studied the different ratesof adhesions caused by these methods using experimental animal studies (pigs).The results of their study showed a significant incidence of adhesions. A higherincidence of neuralgia has also been noted with IPOM (Fitzgibbons et al. 1995).

Multicentre reviews of complications and recurrence rates following LIHRThree multicentre reviews, undertaken in the USA and Europe, have beenpublished showing the complications and recurrence rates associated with thevarious laparoscopic techniques (Tables A1.1, A1.2, A1.3). Fitzgibbons et al.(1995) prospectively analysed the results of three laparoscopic procedures—transabdominal preperitoneal approach (TAPP), intraperitoneal onlay mesh(IPOM) and total extraperitoneal mesh repair(TEP)—performed by 21

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principal investigators at their discretion. Earlier studies by Tetik et al. (1994)and MacFadyen et al. (1993) analysed, in addition to the above three procedures,the plug and patch technique, high ligation of the indirect hernia sac withclosure of the internal ring, and the transperitoneal iliopubic tract repair. Thelatter procedure involved transperitoneal suture approximation of the trans-versalis fascia to the iliopubic tract or Cooper’s ligament. MacFayden et al.reported a conversion rate of 6.6 per cent to an open procedure and both a highcomplication rate (19.8 per cent) and a high recurrence rate (6.6 per cent) andthis technique has since been abandoned.

The study by Tetik et al., based on a questionnaire, included investigators fromboth the United States and Europe. There was no mortality. The overallcomplication rate was given as 13.6 per cent, of which 1.2 per cent were intra-operative. Intra-operative complications directly related to the laparoscopictechnique were low; none with the plug and patch technique, 1 per cent withring closure, 0.9 per cent with both IPOM and TAPP and 1.9 per cent withTEP. These included one colon injury, a needle lost in the abdominal wall, ableeding port site and open conversions. The overall rate of conversion to anopen repair was 0.8 per cent. Conversions were found to be largely associatedwith the degree of surgical experience and occasional equipment failure. Threeintra-operative complications were related to the actual hernia repair. Theseincluded injuries to the spermatic artery, epigastric artery and to the bladder,the latter requiring conversion to an open procedure (IPOM). Tetik et al. statedthat many of the intra-operative complications could have been avoided withgreater technical expertise and better equipment.

Post-operative complications were largely local, with seromas or haematomasinvolving the inguinal canal or trocar site and subcutaneous emphysemapredominating. Other local complications included hydrocele, wound infection,inguinal pain and scrotal haematoma. Local complications were seen mostcommonly following TEP (12.3 per cent), IPOM (5.6 per cent), and TAPP (3.8 per cent). No local complications were noted following ring closure or theplug and patch technique. Neuralgic complications most commonly involvedthe lateral (femoral) cutaneous nerve of the thigh, the genitofemoral nerve andthe intermediate cutaneous branch of the femoral nerve. They were lowestfollowing TEP (0.66 per cent) or TAPP (1.2 per cent), highest following IPOM(4.7 per cent). Two of the neuralgic complications required repeat laparoscopyand staple removal. The rest resolved spontaneously with time. Testicularcomplications were largely confined to the TAPP (1.99 per cent) and TEP(2.4 per cent) repairs and included testicular pain, epididymitis and orchitis.There were no cases of testicular atrophy. The high rate of haematomasencountered in the TAPP and TEP groups were unexpected by the authors.The three small bowel obstructions were associated with adhesion formationand all followed the plug and patch technique and required re-operation. Six ofthe ten mesh complications, such as palpable mesh and migration of the mesh,were seen after the plug and patch technique and three after TAPP. The onerecorded case of an infected mesh occurred with the IPOM technique.

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Although the overall rate of recurrence was 2.2 per cent, with an averagefollow-up of 13 months, the rate varied markedly between different techniques.The TEP and TAPP procedures showed very low rates of recurrence with 0.4and 0.7 per cent respectively. The IPOM technique showed a recurrence rate of2.2 per cent and the plug and patch an unacceptably high rate of 22 per cent.Reasons given for the overall recurrence rate included: mesh size too small,mesh poorly fixed or poorly positioned, and the defect too large (ring closure).

Fitzgibbons et al. did not separate complications out for separate procedures.The rate of complications relating to laparoscopic procedures was 5.4 per cent.This included only one case of bowel perforation and one bladder perforation.There were two cases of bleeding requiring a transfusion and five trocar sitehernias. The rate of complications relating to the hernioplasty was 17.1 per cent.Transient groin or leg pain was experienced by 8.6 per cent of patients with3.6 per cent experiencing lasting groin or leg pain. Neuralgia problems wereexperienced by 12 per cent of IPOM patients. Fitzgibbons examined surgeonexperience against rates of recurrence. It is clearly shown that recurrencerates improved as experience was gained. The incidence of neuralgia alsodecreased with surgeon experience.

MacFadyen’s study is characterised by very short follow-up for the meshtechniques; mean eight months for the plug and patch, five months for TAPP,seven months for TEP. The complication rate was 7.3 per cent for IPOM,9.3 per cent for TAPP and 7.7 per cent for TEP. The TAPP and TEP techniqueshad very low recurrence rates, but the follow-up period was short.

Table A1.1 Multicentre review—MacFadyen et al. (1993)

Sampleselection Procedure

Hernianumber Conversion

Complicationrate (%)

Recurrencerate ( %)

Meanfollow-up(months)

Retrospectivemulticentre

High ligation ofsac and ringclosure

89 0 44 2.2 24

Plug and patcha 87 0 13.5 6.8 8

Transperitonealilio-pubicsuture repair

30 2 19.8 6.6 <6

TAPP 359 0 9.3 0.84 5

IPOM 186 0 7.3 3.2 <5

TEP 90 0 7.7 0.07

a) Procedure confined to indirect hernias;Note: Complications have been divided into three groups by authors; laparoscopic, patient and

hernia. Complication rates stated are for all procedures.

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Table A1.2 Multicentre review—Tetik et al. (1994)

Sampleselection

Procedure Hernianumber

Intra-operativelaparoscopic

complication rate (%)

Complicationrate (%)

Recurrencerate ( %)

Multicentre TAPP 553 0.9 (5) 11.0 0.7

retrospective TEP 457 1.9 (9) 12.2 0.4

IPOM 320 0.9 (3) 13.4 2.2

Plug & patch 82 0.0 (0) n.a. 22.0

Ring closure 102 1.0 (1) n.a. 3.0

Table A1.3 Multicentre review—Fitzgibbons et al. (1995)

Sampleselection

Procedure Hernianumber

Recurrence rate( %)

Complication rates (%)

Laparoscopic Patient Hernia

Multicentreprospective TAPP 562 5.0 41 (5.4) 50 (6.7) 160 (17.1)

Minimumfollow-up15 months

IPOM 217 5.1

TEP 87 0.0

Prospective randomised trialsTo date, only four prospective randomised trials comparing an open standardherniorrhaphy repair with the laparoscopic procedure have been published.The technique of open inguinal hernia repair differed in certain series andincluded: Bassini and McVay (Vogt et al. 1995), tension free darn (Stoker et al. 1994;

Maddern et al. 1994) and tension free mesh (Payne et al. 1994). Three studies examinedthe transabdominal preperitoneal laparoscopic approach (Maddern et al.,Stoker et al., Payne et al.). One study examined a modified onlay technique(Vogt et al.) (see Table A1.4). Similar outcome measures were studied including:post-operative pain, activity levels and clinical outcome. Only some studiestried to ascertain cost. In addition, Maddern et al. sought to assess criticallythe place of day surgery in LIHR.

A prospective randomised trial has been in progress at the Royal BrisbaneHospital since February 1992. It is designed to compare a modified Shouldicerepair with laparoscopic repair, standardised as a large patch of Marlex placedin the extraperitoneal plane anchored by titanium clips. The preliminaryresults of 169 patients randomised into the trial have been presented at the1995 Annual Scientific Meeting of the Royal Australasian College of Surgeons(Nathanson & Adib 1995). No intra-operative conversions were required. Althoughno operative complications occurred, one patient in the open group died duringinduction of anaesthesia. Patients were all discharged the morning followingthe procedure with similar visual analogue scale assessment of pain at three

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hours. However, this assessment at 24 hours and 48 hours was significantlylower in the laparoscopic group with an earlier return to normal activities andwork. By six weeks, the visual analogue scale of local pain was similar. Nopatient has developed bowel obstruction. One hernia recurrence has occurredin the laparoscopic and one in the open group. Nathanson concluded thatlaparoscopic inguinal hernia repair using a large mesh can achieve a soundrepair with equivalent medium-term results to open surgery and will havemost to offer in older patients with bilateral hernia and patients with multiplerecurrences requiring an alternative approach. There are some modest benefitsin reducing post-operative pain in those with unilateral hernia.

Characteristics Vogt et al. (1995) Maddern et al.(1994) (a)

Stoker et al.(1994)

Payne et al.(1994)

Method of sampleselection

prospectiverandomised

prospectiverandomised

prospectiverandomised

prospectiverandomised

Sample sizelaparoscopicopen

3031

4244

7575

4852

Procedurelaparoscopicopen

'onlay' meshBassini McVay

TAPPtension free darn

TAPPtension free darn

TAPPtension free

Mean operative time (minutes)laparoscopicopen

63.280.9

30.530.5

50*(b)unilateral35.0*

68.056.0

Mean hospital stay (hours)laparoscopicopen

n.a.n.a.

3.752.43

10.0*10.0*

4.84.4

Mean return to work (days)laparoscopicopen

7.518.5

17.530.0

14.0*28.0*

9.017.0

Conversion to openrepair 2.0 n.a. 0 (c) 2.0

Complication rates (%)Minorlaparoscopicopen

13.312.9

33.045.0

8.0 (d)21.0

8.018.0

Majorlaparoscopicopen

3.33.2

7.142.27

(d)(d)

4.00

Recurrence ratelaparoscopicopen

3.36.4

4.70

00

0–

Mean follow-up(months) 8.0 8.1 7.0 10.0

Type of anaesthesialaparoscopicopen

GAmix

GALA

GA (e)GA

GAGA

Table A1.4 Summary of randomised trials

Results given as means unless indicated by * when they are given as medians.a) Maddern et al. used medians rather than means for reporting results; b) operative timedecreased with increasing experience to a median of 30 minutes for the last 20 cases; c) oneopen procedure for recurrent hernia converted to laparoscopic repair due to presence ofpreviously implanted mesh; d) complications not categorised as minor or major, only overallcomplication rate stated; e) all procedures performed under day-case anaesthesia.

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Patient selectionPayne et al. restricted their study to symptomatic adult inguinal hernia,excluding paediatric and femoral hernia. Incarcerated hernias were alsoexcluded because of the additional risks and extensive dissection that may berequired. Patients ranged in age from 20 to 70 years and were all consideredsuitable for general anaesthesia and the induction of a pneumoperitoneum. Ofthe initial 123 patients, 100 fulfilled the above selection criteria and wererandomly assigned to either laparoscopic or open repair. No patient withdrewfrom the study after randomisation. In the study by Stoker et al., afterlaparoscopic hernia repair was performed in 35 patients as a feasibility studyand to optimise the technique, 150 patients were randomised to havelaparoscopic or open repair. Patients ranged in age from 18 to 85 years.Similar selection criteria to those employed by Payne et al. were used.Additional causes for exclusions were pregnancy, systemic or local infection orpsychiatric conditions precluding consent. Vogt et al. only excluded patientsunable to give informed consent or unable to understand the protocol. Threepatients dropped out of the open group insisting on a laparoscopic repairoutside the protocol. Maddern et al. only excluded patients if there werecontraindications to general anaesthesia or general surgery.

TechniquePayne et al. used the TAPP approach. Indirect sacs were detached and left inplace to avoid the possibility of ischaemic orchitis associated with complete sacdissection. A SurgiPro mesh (9 x 15 cm) was stapled in place with theEndohernia instrument to cover potential sites of femoral, direct and indirectherniation. Special attention was paid to secure the mesh to Cooper’s ligament(4.0 mm staples) and to avoid the placement of lateral staples below theiliopubic tract. Stoker et al. employed a similar technique using polypropylene(Prolene) mesh (12 x 8 cm). Vogt et al. applied a traditional repair according toeach surgeon’s preference and operative findings, the Bassini and McVayrepairs being most popular. Maddern et al. used the TAPP approach with aProlene mesh that was individually sized for each patient.

Operative timePayne et al. found no statistically significant difference in the mean operativetimes between the laparoscopic and open repair for unilateral, bilateralhernias or recurrent hernias. Stoker et al. reported that the laparoscopicoperation took longer, with more variability in the operative time, than theopen procedure. Operating time did, however, improve as experience wasgained with the new technique. In contrast, Maddern et al. found that, ifbilateral hernia repairs were excluded, the median operative time did notdiffer significantly between the open and laparoscopic repairs.

Length of hospital stayPayne et al. found no statistically significant difference in the mean time todischarge following primary repair of unilateral hernias between the laparo-scopic and open repair. Discharge times following bilateral and recurrenthernias were similar. The need for general anaesthesia did not significantly

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prolong the stay of patients having laparoscopic repair. In contrast, Maddern etal. found that, in patients who were day cases and did not require admission,the median post-operative discharge time was significantly shorter for theopen group (p < 0.05). Vogt et al. state that most patients were dischargedwithin 24 hours of operation.

Post-operative painStoker et al. used three criteria to measure post-operative pain —inpatient useof post-operative analgesia, outpatient use of analgesia, and a visual analoguescale. The other studies similarly measured pain through review of records andasking patients how much analgesia they were taking at various stages offollow-up (Vogt et al., Maddern et al., Stoker et al.), and visual analogue scale(Maddern et al.). Overall the studies indicate that laparoscopic hernia repair isthe less painful operation. However, not all the studies showed this clearly.Generally the results revealed trends rather than significant differences.Payne et al. did not assess pain between the two procedures. Maddern et al.found that the laparoscopic group required less analgesia overall. Stoker et al.found that laparoscopic patients had less pain.

Return to normal activity and work‘Return to work’ is difficult to measure as it may vary with a patient’smotivation and disability coverage as much as with surgical morbidity (Wexner

1993). Payne et al. showed that those patients undergoing laparoscopic repair ofa unilateral hernia returned to work faster than patients undergoing openrepair. Multiple regression analysis controlling for the intensity of the jobfound this difference to be significant (p <0.001) with most significance forthose with jobs that required intense physical activity. There were too fewpatients in the bilateral and recurrent groups to achieve statisticalsignificance. To monitor recovery, Payne et al. also used a panel of exerciseswhich assessed those muscles whose functions are most affected by inguinalhernia repair. Straight leg raising provided the most objective measure ofrecovery. Overall the studies indicate that patients undergoing laparoscopicrepair return to work faster than patients undergoing open repair. Stoker etal., Payne et al., Brooks (1994) and Vogt et al. reported that the laparoscopicgroup returned to work faster than did the open herniorrhaphy group.Maddern et al. found no difference using median, though a trend towardsearlier return to work for the laparoscopic hernia group was noted.

Complications and conversion rateComplications are reported differently throughout the literature makingcomparison difficult. No clear conclusion can be drawn as to which proceduregenerates fewer complications. Payne et al. report a lower rate of complicationsin the laparoscopic group—12 per cent, compared to 18 per cent in the opengroup. Most of these were minor and transient. Urinary retention occurredfollowing one laparoscopic and three open repairs, two of the latter having

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been done under spinal anaesthesia. Other major complications includedincarceration of omentum between the clips used to close the peritoneum overthe mesh and haemorrhage from an aberrant obturator artery necessitatingconversion to an open procedure. There were no incidences of nerveentrapments.

Vogt et al. reported similar complication rates for both procedures. Maddern etal. reported high complication rates in both procedures, but this includes alarge component of minor complications, with bruising and swelling predomin-ating. Three major complications occurred in the laparoscopic group comparedto one in the open group. The former included a porthole haemorrhage andsmall bowel obstruction both requiring re-operation by laparotomy. The smallbowel obstruction resulted from adherence of bowel to the prosthetic mesh.This was caused by a disrupted lateral peritoneal closure post-operatively.Maddern et al. also report four cases of neuropraxia in the laparoscopic group,one attributable to the medial cutaneous nerve of the thigh and three to thelateral cutaneous nerve of the thigh, all resolving within six weeks. Two casesof neuropraxia were reported in the open group. Stoker et al. and Payne et al.report a lower rate of complications in the laparoscopic group.

Both Vogt et al. and Payne et al. reported two conversions from open to laparo-scopic repairs. Open repair for a recurrent hernia to a laparoscopic proceduredue to the presence of previously implanted steel mesh.

Recurrence rate and follow-upPayne et al. had a 98 per cent compliance rate with follow-up ranging fromseven to 18 months (median, 10 months). No recurrence has been noted.Annual review of patients, with examination by two surgeons, will beundertaken for a minimum of five years. A follow-up rate of 95 per cent ispredicted. However, two early (less than 30 days) recurrences occurred withinthe laparoscopic group of Maddern et al.

CostVogt et al. did not discuss costs in relation to their study. Maddern et al. notedthe additional equipment required (mean 1.1 staples for every hernia repaired,three trocars per patient, disposable surgical clip applier to control emergencybleeding) and the need for general anaesthetic. Maddern et al. state that thepresence of a higher incidence of major complications in the laparoscopic groupalso serves to further the economic disparity between the two groups. Stoker etal. note that laparoscopic repair is more expensive, stating that any costadvantage to the community is only due to less days off work post-operatively.

Maddern et al. concluded that their results indicated that LIHR is comparableto the conventional open repair with respect to operative time, post-operativepain and activity levels as well as the number of days required to return towork. This is in contrast to other randomised controlled trials which reportreduced post-operative pain and a more rapid return to work with herniasrepaired laparoscopically. In the Maddern et al. series a trend to earlier workwas noted.

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Literature review—LAHThis literature review is based on a Medline search using the terms laparo-scopy and hysterectomy. In addition, relevant journals not listed on theMedline database (e.g. Journal of the American Association of GynaecologicLaparoscopists and Gynaecological Endoscopy) were searched manually.

The role of hysterectomy in gynaecological practiceThe two most common indications for hysterectomy are dysfunctional uterinebleeding and uterine fibroids, which result in disorders of menstruationcausing excessive menstrual loss or menorrhagia affecting up to 20 per cent ofotherwise healthy women. At a rate of 20 to 30 per 1 000, these women willseek the help of primary care physicians and when referred to a gynaecologistwill represent up to 12 per cent of all gynaecological consultations (Bradlow 1992).The health care costs of abnormal menstruation and associated anaemia, whenrelated to loss of productivity in the work force and home and utilisation ofmedical services are considerable even before expenditure for investigatingand treating this disorder is considered. Medication prescribed for womensuffering from menorrhagia for 1993 in England and Wales resulted in 821 700prescriptions at a cost of £7 176 596. In the same year, 128 000 diagnosticprocedures and 73 000 hysterectomies were performed for the management ofmenorrhagia (Nuffield Institute for Health 1995).

Despite reviews, articles and editorials over the last 20 years which haveexamined the indications, appropriateness, complications and cost effective-ness of hysterectomy, there is still a need for assessing how this procedureaffects the quality of women’s health care. A second primary goal of health careprovision is the need for containing health care costs, particularly in relationto surgical procedures involving expensive new technology. Since its intro-duction, laparoscopic assisted hysterectomy has added to the debate on currentutilisation and cost effectiveness of hysterectomy.

IncidenceIn Western societies, hysterectomy is usually the second most common majoroperation performed after caesarean section. The prevalence of hysterectomyvaries widely in different parts of the world and also within regions with asmuch as a six-fold variance for different countries. The highest rates per 1 000have been recorded in the United States (5.56), Canada (4.70) and Australia(3.97). New Zealand (2.50), U.K. (1.45), Sweden (1.32) and the Netherlands(0.38) have reported much lower rates (Hirsch 1993, Van Keep et al. 1983).

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The incidence of hysterectomy has fallen from a peak in 1975 in the UnitedStates and since 1985 in Canada (Lalonde 1994). There has also been a decline inhysterectomies performed on privately insured patients in Australia in thedecade between 1976 and 1986 (Wood et al. 1992). Despite these trends, thelifetime risk of having a hysterectomy is 22 per cent in Europe and almost50 per cent in the United States (Bunker 1976). Australian studies have indicatedthat 16.9 per cent of all women and 34.2 per cent of women in the over 50 agegroup had undergone this procedure (Schofield et al. 1991).

Factors influencing the prevalence of hysterectomyFactors unrelated to primary indications for hysterectomy which have beenfound to increase hysterectomy rates include parity and menstrual disturbance,repeated fetal loss and intra-uterine contraceptive device ( IUCD) related sideeffects. Less important contributors are social class and availability of resourcesand personnel. Public information campaigns, effective surveillance and qualityassurance studies have been demonstrated to reduce hysterectomy rates.

SterilisationThe relationship between sterilisation and subsequent menstrual abnormalityand need to perform hysterectomy has been a much discussed but, until thelast decade, poorly studied subject. Disruption to ovarian blood supply, andthus to ovarian function, has not been substantiated by luteal phase andendometrial maturation studies (Donnez et al. 1981).

Two year follow-up of a multicentre study involving 2 500 women having electro-cautery and Falope ring sterilisation revealed no increase in the prevalence ofabnormal menstrual function except for dysmenorrhoea associated with theelectrocautery group (DeStefano et al. 1983). Fifteen percent of women who hadexperienced menstrual problems pre-operatively reported an improvementfollowing sterilisation. Stantow and Bracher (1992) found that the incidence ofhysterectomy was lower in women who had been sterilised than in thoseundergoing the procedure due to other factors such as IUCD usage.

Alternative surgical approachesAlternative approaches to the management of leiomyomas and gonadotrophinreleasing hormone agonists, hysteroscopic resection of submucosal myomasand myomectomy are more commonly considered for younger women wantingto preserve fertility. An interesting new approach to defunctioning uterinefibroids has been the radiologic embolisation of uterine arteries to achieve adecrease in uterine and fibroid blood flow (Ravina et al. 1995). More conservativesurgery has also been advocated for treatment of adenomyosis. Doppler flowvaginal ultrasound diagnosis and laparoscopic electrocautery of adenomyosisfoci have been advocated by Wood et al. (1993).

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Endometrial destructive proceduresHowever, the majority of women investigated for menorrhagia with currentlyavailable investigative procedures have no demonstrable organic pathologyand are classified as having dysfunctional uterine bleeding. Members of thisgroup in particular are thought to be the most eligible for transcervical endo-metrial ablation or resection. These procedures are associated with a shorterhospitalisation and convalescence however the need to carry out furthersurgery, either repeat ablation or resection or hysterectomy has been reportedin up to 23 per cent of patients particularly in the longest follow-up studies(Dwyer et al. 1993; Pinion et al. 1994). An Australian study on the outcome of 1 853privately insured patients having endometrial ablation in 1992, reported thatin a 20 to 26 month follow-up period, 10 per cent had hysterectomy, 6 per centhad repeat endometrial ablation and 5 per cent had other gynaecologicalprocedures (Molloy & Taylor 1994). The incidence of endometrial ablation procedureson privately insured patients in Australia reached a peak in 1992 to 1993 withan overall decline in incidence of 46 per cent over the next two years (Molloy &

Crosdale 1996). Data from the same group of patients indicated an almost three-fold increase in the number of laparoscopic assisted vaginal hysterectomiesfrom 1993 to 1995.

Indications for hysterectomyHysterectomy provides an effective solution for the management of menor-rhagia for women who have not responded to medical management. Perceivedor experienced side effects of medical therapy, poor response and unwillingnessto consider prolonged therapy are the main reasons women choose a surgicalremedy. The presence of other pelvic symptoms, particularly pain, genitalprolapse and urinary incontinence, also predispose towards surgery.

Uterine leiomyomas account for 30 per cent, dysfunctional uterine bleeding for20 per cent, endometriosis and adenomyosis for 20 per cent and endometrialhyperplasia for 6 per cent of hysterectomies (Carlson et al. 1993).

History of hysterectomyThe first recorded hysterectomy was performed by Soranus in Greece in thethird century AD. This was a vaginal procedure for an inverted, gangrenousuterus. The patient succumbed (Bachmann 1990). It is surprising to find reports ofa more successful vaginal operation by a Venetian, Giacomo Verengario da Carpi,in the sixteenth century (Hasson 1993). However it was not until the nineteenthcentury that hysterectomy became an operation the patient was likely to survive.

In the early 1800s, hysterectomy was performed exclusively by the vaginalroute. The first recorded abdominal hysterectomy was performed inManchester, England by Heath in 1843. It was a subtotal hysterectomy and, aswith the first vaginal operation, the patient did not survive. It was not until1850 that Burnham in Massachusetts, USA recorded a survival after anabdominal hysterectomy.

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With improved techniques, instruments, anaesthesia and antisepsis, themortality rates for the vaginal operation improved rapidly in the second half ofthe nineteenth century falling to 15 per cent by 1886, 10 per cent by 1890 and2.5 per cent in 1910. The rates for abdominal hysterectomy lagged well behindthese figures and were reportedly still greater than 70 per cent in 1880. It wasnot until the 1930s that mortality rates reached three per cent, a levelachieved 20 years earlier by vaginal hysterectomy (Bachmann 1990).

Before 1940, 95 per cent of abdominal hysterectomies in the United Stateswere subtotal (Hasson 1993). This began to change from the mid 1940s withoutcomes improving with the introduction of penicillin and more widespreaduse of blood transfusions. The incidence of carcinoma in the cervical stump,reported at 1 to 2 per cent at this time, also hastened the decline in popularityof the subtotal operation (Carter et al. 1949; Pratt & Jeffries 1976).

From this time on, numbers of women undergoing hysterectomy increaseddramatically throughout the world and total abdominal hysterectomy becamethe dominant procedure in most centres. There are exceptions to this rulewhere the practice of either vaginal or subtotal hysterectomy continued to bepromoted (Kilkku 1983; Kilkku 1985; Kovac 1986; Pedlow 1995).

In current gynaecological practice, there is reasonable agreement by gynaeco-logists trained in British, European and United States hospitals that thevaginal route provides a safe and cost-effective way of removing the uteruswith least morbidity and mortality. Except for the very accomplished andmotivated vaginal surgeon however, the presence of a large uterine mass(greater than 12 week size), associated endometriosis, pelvic adhesions, theneed to carry out bilateral oophorectomy, vaginal scarring and nulliparity areusually considered contraindications to vaginal surgery and the abdominalroute is then chosen.

The fact remains, however, that the majority of hysterectomies are performedabdominally. In the UK in 1993/94 only 19.2 per cent of hysterectomies wereperformed vaginally (Nuffield Institute for Health 1995). Australian Health InsuranceCommission data indicate that Medicare benefit payments in 1991/92 accountedfor 68.7 per cent abdominal and 28.5 per cent vaginal hysterectomies. Thesame source (Hirsch 1993) revealed a slight increase in vaginal and decrease inabdominal hysterectomies between 1989 and 1992.

The impact of laparoscopic assisted hysterectomySince being introduced by Reich in 1989 (Reich et al. 1989) laparoscopic assistedhysterectomy procedures have been performed by surgeons skilled in endo-scopic surgery. Although the procedure is carried out in increasing numbers ofcases, it is still early to assess whether the introduction of this procedure willreduce the number of abdominal hysterectomies. The impact of laparoscopicsurgery on vaginal hysterectomy was assessed by Querleu et al. (1993). Over aone year period, 149 patients had hysterectomy performed by surgeonsexperienced in vaginal and laparoscopic surgery. Patients suffering malignant

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disease and vaginal prolapse requiring colporraphy and sacrospinous fixationwere excluded from the study. Vaginal hysterectomy was achieved in 114 cases(77 per cent), laparoscopic assisted vaginal hysterectomy (LAVH) in 26 cases(17 per cent) and abdominal hysterectomy was necessary in only nine cases(six per cent). Following retrospective comparison of the first 115 laparoscopicassisted vaginal hysterectomies with vaginal and abdominal hysterectomies atone medical centre, Casey et al. (1994) concluded that LAVH was performed forcases that would have been otherwise selected for abdominal rather than vaginalhysterectomy and that LAVH was expected to replace many abdominal hyster-ectomies in the future. Findings from a retrospective study involving 2 563hysterectomies performed in a large metropolitan non-profit hospital involving 37gynaecologists over a three year period (1991 to 1993) also indicated a reduction inabdominal hysterectomy from 65 to 36 per cent. Results differed from those ofQuerleu’s study in that LAVH was found to have increased from 12 to 45 per centand vaginal hysterectomy varied from 19 to 23 per cent (Johns et al. 1995).

However, the conclusion reached by Richardson et al. (1995) from a prospectiverandomised controlled study to assess whether most women offered abdominalhysterectomy could have the procedure performed vaginally, was that up to75 per cent of their patients could be treated by vaginal surgery. Theysuggested that previous pelvic surgery, mild endometriosis, history of pelvicsepsis or uterine fibroids need not be contraindications to vaginal surgery. Theseries of 349 cases presented by Browne and Frazer (1991) and that of 617 casespresented by Kovac (1995) attest to the fact that dedicated vaginal surgeons canperform hysterectomy in 70 to 89 per cent of patients.

Currently, LAH has not gained widespread acceptance. The Medicare databaseindicates that in Australia in the years 1994 to 1995, 8 per cent of hysterectomieswere performed laparoscopically. Of over 1 000 gynaecologists in Australia,only 162 had attempted the operation and of these 105 had performed fewerthan three operations (Molloy & Crosdale 1996).

In his original description of LAH, Reich described the operation as a ‘chanceto avoid abdominal hysterectomy and its chief disadvantage, the prolongedrecovery period, while retaining the surgical advantages of the abdominalapproach, such as thorough visualisation and easy access to vascular pedicles’.

Assessment of the role of LAH has been made difficult for several reasons.

• Before the introduction of LAH, no firm agreement had been reached amonggynaecologists as to the relative indications for vaginal and abdominalhysterectomy. If the role of LAH is to replace the abdominal hysterectomy,the overall incidence of abdominal procedures will influence the numberperformed laparoscopically.

• There has also been a lack of agreement as to what constitutes a laparo-scopic assisted hysterectomy. Views range from diagnostic laparoscopy beingperformed in conjunction with vaginal hysterectomy to a total laparoscopicoperation which includes closure of the vaginal vault by laparoscopic suturing(Johns & Diamond 1994; Nezhat et al. 1995; Reich et al. 1993; Munro & Parker 1993; see Table A2.1).

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• The role for expensive but time efficient disposable equipment remainscontroversial (Nezhat et al. 1994).

• Comparisons between vaginal hysterectomy and LAH have further confusedthe issue. Claims that LAH is superior in relation to post-operative pain,return to normal activity and surgical complications have been attributed tothe use of stapling devices rather than that of traditional ligatures withconsequent greater tissue necrosis. Improved haemostasis achieved withpelvic lavage and diathermy at the completion of the laparoscopic procedurehave also been claimed to improve results (Baggish 1992; Donnez & Nisolle 1993; Drife

1994; McCartney & Johnson 1995). Lesser morbidity and quicker recovery have alsobeen noted (Hunter & McCartney 1993; Jones 1993; Rosemann 1994).

• The introduction of laparoscopic subtotal hysterectomy, which entails removalof the body of the uterus by morcellation and retention of the cervix, avoidsentry via the vagina and dissection below the level of the ascending branchof the uterine artery, thus lessening the chance of uterine artery haemor-rhage and urinary tract damage. As a consequence of the re-introduction ofthis operation the debate on the appropriateness of retaining the cervix athysterectomy has resurfaced.

The comparisons to be made are not just between the vaginal, abdominal andlaparoscopic route for hysterectomy but also between the various types oflaparoscopy assisted hysterectomy.

Types of laparoscopic assisted hysterectomyThe main variation between the different surgical approaches is the degree towhich the operation is performed vaginally. Reich’s original descriptioninvolved performing the hysterectomy laparoscopically to the extent of openingthe anterior and posterior fornix of the vagina. The vaginal portion of theoperation only involved cutting the uterosacral ligaments and closing thevagina. Since then, Reich and others have described techniques for performingthe whole operation laparoscopically (Hourcarbie & Bruhat 1993; Chapron et al. 1994; Garry

1994c; Pelosi & Pelosi 1994).

Although consensus has not been reached on a classification system for LAH, anumber of proposed classifications (listed in Table A2.1) reflect the commonlyused terminology (Reich et al. 1993; Munro & Parker 1993; Nezhat et al. 1994). This providesa confusing, overlapping array of terms and operations under the banner oflaparoscopic hysterectomy. The same terms can be used to describe differentoperations as illustrated by the different meanings given to laparoscopicallyassisted vaginal hysterectomy in the classifications previously mentioned.Reich et al. used it to describe a vaginal hysterectomy combined withlaparoscopic adhesiolysis, excision of endometriosis or oophorectomy whereasNezhat et al. described it as a hysterectomy performed using up to three laparo-scopic steps generally not including dividing the uterine arteries (Baggish 1992).

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Table A2.1 Classifications for laparoscopic hysterectomy

Classification 1Stage Laparoscopic component of hysterectomy

0 Laparoscopy done but no laparoscpic procedure before vaginal hysterectomy

1 Procedure includes laparoscopic adhesiolysis and/or excision of endometriosis

2 Either or both adnexae freed laparoscopically

3 Bladder dissected from the uterus laparoscopically

4 Uterine artery transected laparoscopically

5 Anterior and/or posterior colpotomy or entire uterus freed laparoscopically

Source: Johns & Diamond (1994)

Classification 2Type of hysterectomy Description

Total laparoscopic hysterectomy(TLH) All steps performed laparoscopically

Subtotal laparoscopic hysterectomy(SLH) All steps performed laparoscopically

Vaginally assisted laparoscopic hysterectomy(VALH) Four or more steps perfomed laparo-scopically, procedure completed vaginally

Laparoscopically assisted vaginal hysterectomy(LAVH) Less than four steps performed laparo-scopically, procedure completed vaginally

Source: Nezhat et al. (1995)

Classification 3Diagnostic laparoscopy with vaginal hysterectomy

Vaginal hysterectomy with laparoscopic vault suspension (LVS)

Laparoscopically assisted vaginal hysterectomy (LAVH—can be with morcellation and/or LVS)

Laparoscopic hysterectomy (LH—can be with morcellation and/or LVS)

Total laparoscopic hysterectomy (TLH—can be with morcellation and/or LVS)

Laparoscopic supracervical hysterectomy (LSH)

Laparoscopic hysterectomy with lymphadenectomy

Laparoscopic hysterectomy with lymphadenectomy and omentectomy

Laparoscopic radical hysterectomy with lymphadenectomy

Source: Reich et al. (1993)

Classification 4Type I Laparoscopically directed preparation for vaginal hysterectomy

Type II Type I + uterine artery and vein occlusion, unilateral or bilateral

Type III Type II + portion of cardinal - uterosacral ligament complex; unilateral or bilateral

Type IV Type II + total cardinal - uterosacral ligament complex; unilateral or bilateral

Each type is further divided into 4–5 subtypes depending on the other laparoscopic steps performed

Source: Munro & Parker (1993)

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The most common focus in attempting to classify laparoscopic hysterectomy iswhether the uterine artery is divided laparoscopically or vaginally. If theuterine artery is divided vaginally, the procedure is generally described aslaparoscopically assisted vaginal hysterectomy. The laparoscopic part of theoperation will consist of division of the broad ligament and adnexae andprobably division of the uterovesical peritoneum and reflection of the bladder.If the uterine artery is divided laparoscopically, the operation is commonlytermed a laparoscopic hysterectomy. In this case, the laparoscopic steps mayalso include division of the uterosacral-cardinal ligament complex, opening theanterior and/or posterior vaginal fornix to allow complete removal of theuterus. Where the vaginal vault has been closed laparoscopically the term totallaparoscopic hysterectomy is generally used.

Other terms such as laparovaginal hysterectomy and vaginally assistedlaparoscopic hysterectomy have been proposed but not generally accepted asthey overlap and attempt to replace the above descriptions (Donnez & Nisolle 1993;

Drife 1994; McCartney & Johnson 1995, Hourcarbie & Bruhat 1993).

The term laparoscopic subtotal hysterectomy covers the other main group ofoperations. It involves leaving the cervix and excising the body of the uterusafter dividing the ascending uterine artery. The uterus is removed either viaculdotomy, enlargement of the umbilical incision and morcellation or via thelaparoscopic ports. The operation may also involve ablation or excision of theendocervical canal to remove any remaining endothelium and thetransformation zone of the cervix.

Table A2.2 presents the findings from the various series of laparoscopichysterectomy found in the literature. The number of procedures, technique,operative time, bed days, return to normal activity, complications, conversionto laparotomy and use of disposable versus non-disposable equipment havebeen annotated.

Morbidity and mortality of hysterectomy proceduresHysterectomy procedures are associated with mortality and significantmorbidity. Reviews of various studies indicate that mortality rates for hyster-ectomy vary from 0.4 to 2 per 1 000 women with lower mortality rates reportedfor vaginal (one per 1 000) than for abdominal hysterectomy (two per 1 000)(Nuffield Institute for Health 1995). Deaths are commonly associated with cardiac orpulmonary arrest and pulmonary emboli (Martin & Benson 1987; Osborne et al. 1991).

Vaginal and abdominal hysterectomyDicker et al. (1982) reported a series of complications for vaginal and abdominalhysterectomies. This prospective multicentre observational study compared568 women undergoing vaginal hysterectomy with 1 283 women undergoingabdominal hysterectomy. The authors found the rate of complication per 100hysterectomies to be 30.7 for vaginal versus 52.7 for abdominal hysterectomyand the number of women having one or more complications to be 24.5 per centfor the vaginal operation compared to 42.8 per cent for the abdominal. These

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uth

or

Date

Nu

mb

erT

echn

iqu

eO

perative

time (m

in)

Bed

stay(d

ays)N

orm

al activity(d

ays)C

om

plicatio

ns

(no

. [%])

Co

nversio

ns

Eq

uip

men

t

Minelli

19917

LH/LA

VH

90–1804

–nil

nilnon disp.

Maher

Feb 1992

17LH

1603.1

161 (5.9)

nilnon disp.

LiuA

pr 199272

LH120

1.18–

2 (2.8)nil

non disp.

LiuJun 1992

215LH

1141.21

–10 (4.2)*

1m

ixed

Hourcabie

1993103

TLH

<60–>

1205.29

–6 (5.8)

1staples

Phipps

1993114

LH/LA

VH

742.0

215 (4.2)*

nilstaples

Saye

1993171

Doderlein

59<

23 hrs16

nil4

staples

Reich

1993123

TLH

/LAV

H180

2–

17 (13.8)**1

staples

Canis

199333

LH149

4.814

8 (24)9

non disp.

Schw

artzJun 1993

45LS

H/LA

VH

––

–(95)***

nil–

Daniell

Jul 199368

LH137

2.69–

4 (5.8)6

mixed

LeeA

ug 199382

LH152

2.6–

6 (8.3)2

staples

Davis

Aug 1993

46LH

1911.2

–>

36 (>78)

6m

ixed

JonesO

ct 1993100

LH123

–22

26 (26)1

–

Hunter

Oct 1993

54LH

1464

217 (13)

1staple/clips

Nezhat

1994361

TLH

/LAV

H138

1.9–

40 (11.1)1

non disp.

Liu1994

518LH

1201.4

–30 (5.76)

–m

ixed

Kadar

199424

LH192

3.3–

nilnil

–

Wood

1994141

LH>

120<

3–

22 (15)–

mixed

Makinen

199411

LH207

2.614

2 (18.2)nil

staples

Chapron

199431

TLH

1714

–3 (9.6)

1staples

JohnsJun 1994

119LH

/LAV

H79

2.5–

5 (4.2)nil

staples

Calandra

1995153

LAV

H–

––

16 (10.5)6

non disp.

Jones1995

252LH

––

–37 (14.7)

––

Angle

Feb 1995

108LH

/LAV

H197

2.4–

34 (38.7)16

mixed

Garry

Apr 1995

20D

oderlein93

3–

3 (15)nil

non disp.

Bronitsky

May 1995

62LA

VH

––

–6 (9.7)

2m

ixed

InsullJul 1995

118LA

VH

1203

21not specified

nilstaples

T/L

H—

total/laparoscopic hysterectom

y; LA

VH

—laparoscopic assisted vagin

al hysterectom

y;L

SH

—laparoscopic su

btota l hysterectom

y; * all complication

s major; ** 11(8.9%

) of 17 complication

s major; *** 56%

=equipm

ent failu

re

Table A2.2 Published series of laparoscopic hysterectomies

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complications were compiled from categories defined at the beginning of thetrial. In addition there were a number of complications that were not definedunder these categories including urinary retention, atelectasis, ileus and otherswhich added a further 16.3 and 13.5 to the respective complication rates. Thisstudy has been used as the basis for comparison for most of the publishedseries of laparoscopic hysterectomy complications.

A number of points should be made about this benchmark study. Dicker ’sseries of complications contain a high proportion of both febrile morbidity andblood transfusions. The use of prophylactic antibiotics, which has been shownto reduce febrile morbidity especially in vaginal surgery, was not routineduring this series (82 per cent in vaginal cases and 32 per cent in abdominal),as it is currently. The American College of Obstetricians and Gynaecologists,after reviewing the literature, supported the use of prophylactic antibiotics asa means of reducing febrile morbidity and infection in abdominal hysterectomies(Kadar & Pelosi 1994). It is also reasonable to assume that, in the pre-AIDS era,blood transfusions were used more readily. There was also a high proportion ofcases that had additional procedures performed. Appendicectomy was performedwith 17.5 per cent of the abdominal operations and 44.5 per cent of the vaginalhysterectomies also underwent a colporraphy. The latter group had three timesthe incidence of urinary retention than did the group that underwent vaginalhysterectomy alone. These factors limit the usefulness of Dicker’s data as asuitable comparison for current studies.

Complications for laparoscopic assisted hysterectomyOne of the major criticisms made by opponents of LAH is that these procedureshave a high intra-operative complication rate. Unfortunately available data ofcomplications of LAH have largely come from small retrospective studiesinvolving either single or small groups of surgeons with a particular interest inlaparoscopic surgery. Estimates of complication rates vary from 4.2 to 38 per cent.The usefulness of comparing these to previous studies is questionable as thereis little uniformity in either the reporting or classification of complications.Retrospective studies are often criticised for underreporting complications asthey are dependant on how rigorous the initial storage and subsequentretrieval of information has been. Complication rates would also be expected tovary according to the learning curve of experience of individual surgeons.Jones (1995) found an overall reduction in complications to 68 per cent in thesecond half of a study involving 252 cases.

Morbidity associated with LAH procedures was recently reviewed by meta-analysis of 29 studies (Garry & Phillips 1995). Surgeons considered by the authorsto be ‘most skilled gynaecological laparoscopists’ contributed 3 184 cases.Febrile morbidity (4.3 per cent) and need to convert to laparotomy (3.45 per cent)were the most common complications. Trochar injuries (2.57 per cent), bowelinjury (0.47 per cent) and urinary tract damage occurred in 1.38 per cent ofcases. Comparison with the study by Dicker et al. (1982) of complications ofvaginal and abdominal hysterectomy indicated a lower febrile morbidity and

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need for transfusion and comparable rates for unintended major surgery, boweland urinary tract trauma and incidence of pulmonary embolus. The overallcomplication rate per 1 000 women for LAH was 15.6 compared to 24.5 forvaginal and 42.8 for abdominal hysterectomy.

While there are obvious limitations in comparing a group of small retro-spective reports with a multicentre prospect trial from 1982 it does providesome substance to the argument that the laparoscopic approach has anacceptable complication rate.

More recent attempts to compare complications in abdominal, vaginal andlaparoscopic hysterectomies are seen in Table A2.2 (Calandra 1995; Jones 1995; Angle

et al. 1995). These consist of small uncontrolled retrospective studies which haveconsistently found no evidence that LAH has an unacceptably high complica-tion rate. Redwine (1995) found very little difference in complication ratesbetween the groups while Harris and Olive (1994) and Boike et al. (1993) foundthe complication rate for laparoscopic hysterectomy intermediate between thevaginal and abdominal procedures (see Table A2.3). Until the results of largeprospective randomised trials are available, the results of these studies willremain the best source of comparison.

Table A2.3 Complication rates for hysterectomy (number/100 cases)

Of greater concern is the suggestion that laparoscopic hysterectomy is morefrequently associated with less common but more significant complications, inparticular bladder or ureteric injury. A number of studies have reportedureteric and bladder complications in numbers greater than expected. Dicker’sstudy indicated a bladder/ureter complication rate of 1.6 per cent for vaginalhysterectomy and 0.5 per cent for abdominal hysterectomy. Recent laparo-scopic series have reported higher than expected rates of up to 4.8 per cent(Baggish 1992). Although the numbers are small, there are some similarities thathave led to increased awareness of potential pitfalls. The ureter has beeninvolved in a number of injuries associated with uterine artery division,particularly when disposable staples are used. This has been attributed to thewidth of the six rows of staples leading to division of the ureter when its closeproximity to the artery has been recognised. Hunter and McCartney (1993)described bilateral ureteric transection by this method. A number of surgical

Abdominal Vaginal Laparoscopic

cases comp. rate cases comp. rate cases comp. rate

Redwine (1995) 88 10.2 67 13.4 109 11.9

Harris & Olive(1994) 25 20.0 25 12.0 25 16.0

Boike et al.(1993) 50 26.0 50 6.0 50 12.0

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strategies have been suggested to overcome this problem. They include routinedissection of the ureters from the lateral pelvic wall before commencing thehysterectomy (Maher et al. 1992), the use of illuminated ureteric stents if theureter cannot be identified (Alvarez-Rodas et al. 1994) or avoidance of the use of thestaples for closure of the uterine artery (Jones 1993; Liu 1992). Conversely, otherauthors have suggested that bipolar diathermy near the ureter is a greaterthreat and recommended the use of a stapling device (Nezhat et al. 1995). Forsome, cystoscopy has become a standard procedure at the conclusion of LAH(Alvarez-Rodas et al. 1994). It is clear that each surgeon must ensure that care istaken to protect the ureters before dividing the uterine arteries anduterosacral-cardinal ligament complex during LAH.

To assess the complication rate of laparoscopic assisted vaginal hysterectomyduring the learning phase, the incidence of major and minor complicationsnoted by gynaecologists in South Australia was analysed from medical recordsof all private and public hospitals in South Australia where the procedure hadbeen performed (O’Shea & Petrucco 1996). The audit of 760 LAVH cases performedduring 1991 to 1994 revealed an overall major complication rate of 110 per1 000 including haemorrhage (30 per 1 000), febrile morbidity (41.5 per 1 000)and bowel injury (6.2 per 1 000). Urinary tract injury occurred in 2.4 per centof cases, ureteric injury in 0.5 per cent, bladder injury in 0.9 per cent and latediagnosis in 1.1 per cent.

The results of this audit support the contention that occlusion of the uterineartery, particularly in the learning phase, is associated with greater morbiditydue to damage to the ureter and bladder or to causing more excessive haemor-rhage than would be expected for abdominal hysterectomy. Attempts to simplifythe laparoscopic procedure include the modifications of laparoscopic Doederlein(LD), laparovaginal and laparoscopic supracervical hysterectomy (LSH). TheLD procedure involves division of the upper pedicles and parametriumlaparoscopically to the level of the uterine arteries. The uterine fundus is thenextracted vaginally by traction via an anterior colpotomy incision. The uterineand cardinal/uterosacral ligament pedicles are then secured vaginally. Thismodification combines an easier approach to the upper pedicles with vaginalsuturing of the lower pedicles, using techniques which are safe and well knownto all gynaecologists (Garry 1994a).

In an effort to reduce prolonged raised intraperitoneal pressure and to com-pensate for loss of pneumoperitoneum when the vagina is opened, Maher et al.(1994) used an abdominal wall elevator and combined laparoscopic and vaginalapplication of a stapling gun to secure all pedicles.

Complications directly related to laparoscopy must also be considered. Theyare not common and therefore not often seen in small series of cases. Theyinclude gas embolus, injury to the major retroperitoneal blood vessels andbowel injury which may go unrecognised. Other laparoscopic complicationsencountered in the literature include Ritcher’s hernia and damage to inferiorepigastric blood vessels.

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Prospective randomised trialsThere are a number of small prospective randomised trials in the literature.They can be placed into two groups. There are two studies comparing totalabdominal hysterectomy and bilateral salpingo-oophorectomy with laparo-scopic assisted vaginal hysterectomy and bilateral salpingo-oophorectomy. Thefindings are listed in Table A2.4 (Raju & Auld 1994; Phipps & Nayak 1993). Two otherstudies comparing laparoscopic hysterectomy with vaginal hysterectomy arepresented in Table A2.5 (Richardson et al 1995; Summitt et al. 1992).

Table A2.4 Randomised controlled trials of abdominal versuslaparoscopic hysterectomy

Table A2.5 Randomised controlled trials of vaginal versuslaparoscopic hysterectomy

Richardson et al. (1995) Summitt et al. (1992)

LH VH LAVH VH

Sample size 22 23 29 27

Operating time (min) 131 77 120.1 64.7

Analgesia (days) 2.9 2.6 not recorded

Hospital stay (days) 3.2 3.3 12 hrs 12 hrs

Return to activity (days) 23.1 22.2 not recorded

Return to work (weeks) 6.4 5.7 not recorded

Complications 36% 30% 1 2

Cost (US$) not recorded 7 905 4 891

Raju & Auld (1994) Phipps & Nayak (1993)

LAVH/BSO TAH/BSO LAVH/BSO TAH/BSO

Sample size 40 40 24 29

Operating time (min) 100 57 65 30

Analgesia 6.6 (days) 13.3 1.5 (doses) 4.5

Hospital stay (days) 3.5 6.0 2.0 6.0

Return to work (days) 21 42 14 42

Complications minimal no difference nil nil

Disposables cost (£) 225 30 500 50

Total cost (£) 1 260 1 750 not stated

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Patient selectionBoth studies comparing abdominal to laparoscopic hysterectomy used patientsrequiring oophorectomies. This has historically been seen as a contraindicationto vaginal surgery. Patients were therefore selected from a group who, in theauthors’ hands, would have normally undergone abdominal surgery. Not allwould agree that oophorectomy is a contraindication to vaginal hysterectomy(Richardson et al.). Of the 6 866 vaginal hysterectomies performed under theAustralian Medicare database in 1994, 5 738 or 10.7 per cent underwentoophorectomy (Molloy & Crosdale 1996). Raju and Auld used computer generatednumbers for randomisation but Phipps and Nayak used odd or even numbersfrom the patient’s hospital record.

Summitt et al. in their comparison of laparoscopic and vaginal hysterectomyselected patients from a group judged by the attending staff at the hospital tobe suitable for vaginal hysterectomy. Three subjective criteria were used inassessment:

• uterus no larger than 16 weeks;• uterine abnormality; and• pubic arch greater than 90 degrees.

They did not use planned oophorectomy or previous pelvic surgery asexclusions. Randomisation was assigned by a computer generated number.

Richardson et al. took the opposite approach. They prospectively reviewed agroup of 98 women who had relative contraindications to vaginal surgery. Ofthis group, 75 underwent laparoscopic hysterectomy. Of these, 22 wereincluded in the study along with the remaining 23 (who were randomised tovaginal hysterectomy) in a prospective randomised trial. Examples of thecontraindications were listed as absence of prolapse, nulliparity, uterineenlargement, previous pelvic surgery, endometriosis and the need foroophorectomy. Exclusions from the study included uterus greater than 16 weeksize, endometrial carcinoma, adnexal masses, known dense pelvic adhesionsand moderate–severe endometriosis. A criticism of the selection method wouldbe that the authors included the softer contraindications about which there isnot universal agreement and used the more absolute contraindications asexclusions. It would be useful to know the percentage of patients excluded onthese criteria. Randomisation occurred by a random numbers table.

TechniquesThere was variety in the laparoscopic approach used in the four trials. Rajuand Auld divided the ovarian pedicle with a stapling technique, reflected thebladder laparoscopically and then completed the procedure vaginally. Phippsand Nayak extended the laparoscopic part of the operation to divide theuterine artery with staples and then completed the operation vaginally.Summitt et al. opened the anterior fornix laparoscopically and in a proportionof the cases divided the cardinal ligaments with the staple gun. Richardson etal. varied the degree by which the operation was performed laparoscopically,converting to a vaginal operation at the earliest opportunity. They generally

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used bipolar dessication and scissors to divide pedicles but on the eightoccasions the uterine pedicle was divided laparoscopically the disposablestapler was used.

Operating timeIn all four studies, a great difference was found between operating times forthe laparoscopic and vaginal or abdominal procedures. The operating time wasapproximately doubled for the laparoscopic procedures. The difference wasstatistically significant in three of the studies and was not commented on byRichardson et al. who found, however, that operating time increased when thegreatest proportion of the operation was completed laparoscopically.Additionally they found that oophorectomy, when performed laparoscopicallyor vaginally, increased the operating time and that vaginal hysterectomy withoophorectomy was quicker than when oophorectomy was performed laparo-scopically. In the available studies a considerable discrepancy in operatingtime exists. However, as the studies rarely indicate how operating time wasmeasured, it is difficult to compare or assess this parameter.

AnalgesiaBoth trials involving abdominal hysterectomy demonstrated a significantlyincreased analgesia requirement in the laparotomy group measured as eitherdays requiring analgesia or doses of morphine used. Summitt et al. recordeddoses of analgesia required rather than the number of days for which it wasrequired. This study showed a statistically significant increase in the amountof oral analgesia required post-operatively in the laparoscopic group but thiswas not considered clinically significant. Richardson et al. found no significantdifference in analgesia requirements between vaginal and laparoscopic surgerygroups.

Hospital stayNot unexpectedly, the patients undergoing abdominal operations requiredstatistically significantly more time in hospital. In view of current policiesthroughout the world for early discharge from hospital, it is rather surprisingto find that the abdominal hysterectomy cases remained in hospital for sixdays. There was no difference in bed days between the vaginal and laparo-scopic operations. In the Summitt et al. study, 53 of the 55 patients in whomthe operation was completed successfully were discharged within 12 hours.They also had home nursing and close medical supervision after discharge.Although this style of management is unusual in current Australiangynaecological practice the need for early discharge for cost containment mayencourage its introduction in this country.

Return to work/normal activitiesStatistically significant differences were found in the time taken to return towork in favour of laparoscopic hysterectomy in both studies comparing thisprocedure to abdominal hysterectomy. No differences were found in theseparameters between vaginal hysterectomy and LAVH in Richardson’s study.Summitt et al. did not comment on return to work.

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ComplicationsWith the small numbers involved in these trials, a meaningful comparison ofcomplications is difficult. Essentially none of the trials found a major differ-ence between their two arms in terms of complications. The lack of uniformityin the reporting of complications may explain partly the differences betweenstudies. While Richardson et al. reported complications of 36 per cent and 30per cent (these were reduced to 18 per cent and 13 per cent if equipmentfailure and unexplained pyrexia are excluded) respectively for laparoscopic andvaginal hysterectomy, Phipps and Nayak had no complications at all and Rajuand Auld had minimal complications with no difference between the groups.

Conversion to laparotomyConversion to abdominal hysterectomy occurred twice in each study except forin that by Phipps and Nayak where it did not occur at all. Raju and Auld’s twoconversions were related to haemorrhage secondary to a trochar injury to aninferior epigastric artery in one case and to haemorrhage from a uterine vesselin the other. Summitt’s two laparotomy conversions both occurred withlaparoscopic cases, one due to an inadvertent cystotomy and the other to atrochar injury to an inferior epigastric artery. Richardson et al. had onelaparoscopic case converted to laparotomy due to haemorrhage and acystotomy. Another bladder injury was repaired vaginally. A laparoscopy wasperformed in a further case to control persistent minor bleeding from anovarian pedicle.

CostsThe increased cost of LAVH was demonstrated in all four studies. Phipps andNayak showed a ten-fold increase in costs for LAVH when using disposableequipment in comparison to abdominal hysterectomy. Although they did notmention it, to the basic costs should be added costs related to increased theatreutilisation and other ancillary costs. It was considered that the increasedoperating costs were offset by the direct savings made by reducing bed days.Similarly, Raju and Auld found that when disposables were used costs weremuch higher in the laparoscopic cases but total costs were lower (£1 260 versus£1 750). The potential indirect savings for the community related to the morerapid return to work and normal activities were not costed. In the studycomparing LAVH and vaginal hysterectomy, the increased operating costscould not be offset by either a saving in bed days or return to work and normalactivity as these were expected to be similar.

Prospective/retrospective non-randomised studiesThere are a number of small non-randomised prospective or retrospectivestudies comparing various types of LAH. The comparisons tended to concen-trate on operative times, bed days and costs. In general the findings aresimilar to those found in the four randomised prospective trials. The smallnumbers and possibility of selection bias make it more difficult to draw anyfirm conclusions.

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There are two prospective non-randomised studies comparing laparoscopicwith abdominal hysterectomy (Table A2.6)(Elia et al. 1995; Sadik et al. 1995). Elia et al.compared laparoscopic assisted vaginal hysterectomy (uterine arteries dividedvaginally) with abdominal hysterectomy for patients who had been assessed asbeing unsuitable for vaginal hysterectomy. The time of operation was selectedby the patients themselves. Sadik et al. compared the findings of 50 consecutivepatients who had laparoscopic hysterectomy and bilateral salpingo-oophorec-tomy with 37 women undergoing abdominal hysterectomy performed by othersurgeons from the same hospital waiting list and over the same period of time.

Table A2.6 Nonrandomised prospective trials

Elia et al. (1995) Sadik et al. (1995)

LAVH TAH LH TAH

Sample size 19 18 50 37

Selection of groups patient preference non random

Operating time (min) 156 126 96 76

Pain (days/doses) 1.1 8.5 1.0 3.5

Bed stay (days) 3.0 4.0 3.7 4.5

Return to work (weeks) 1.9 5.0 not recorded

Cost not estimated not estimated

The conclusions were similar with both studies finding that the laparoscopicprocedure took a statistically significantly longer time to perform but thatpatients required less analgesia and were discharged and returned to workmore quickly. Again the differences in operating times between studies wasapparent with Sadik’s laparoscopic hysterectomies taking 60 minutes less toperform despite having a greater laparoscopic component.

The results of retrospective studies comparing the three forms of hysterectomyfor bed stay and cost is illustrated in Table A2.7. All the studies showed laparo-scopic hysterectomy to have the shortest bed stay though this was notappreciably different to vaginal hysterectomy. In a New Zealand study, East(1994) found laparoscopic hysterectomy to be a very time consuming procedure.He measured total theatre time and found it to be more than three timeslonger than that required for vaginal and two times longer than that requiredfor abdominal hysterectomy (167 versus 48 versus 73 minutes). He estimatedthat 20 to 25 minutes of this difference was due to the extra set-up timeinvolved with laparoscopic surgery.

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The South Australian retrospective audit (using statistics derived from hospitalmedical record departments without any surgeon’s input) demonstrated for the760 LAH performed from 1991 to 1994 a mean operating time of 129 minutes(25 to 360) and average hospital stay of 4.9 days (2 to 16).

These retrospective studies consistently demonstrate that laparoscopichysterectomy is the most expensive hysterectomy, the cost mainly associatedwith increased theatre costs and the use of disposable equipment. Nezhat et al.(1994) compared 30 hysterectomies from each group in a retrospective review intheir own hospital. The cases were selected randomly by a computer selectionmethod. They found the cost of laparoscopically assisted vaginal hysterectomywith the linear stapler to be significantly greater than that for either vaginalor abdominal hysterectomy. There was no difference in cost between vaginaland abdominal hysterectomy. They also compared a group of 23 laparoscopichysterectomies performed over the same period of time using the carbondioxide laser and bipolar diathermy instead of a disposable staple gun. Thecosts in the latter group were comparable to those for the vaginal andabdominal operations.

Redwine (1995) retrospectively studied all patients undergoing hysterectomy ata community based rural hospital over a 30 month period. He made a com-plicated comparison between all vaginal and abdominal operations againstlaparoscopic hysterectomy according to which surgeon performed the operation(each using a different technique). Such a comparison is prone to many biases.His conclusion was that the use of a video monitor and disposable equipmentwas associated with greater costs and that vaginal hysterectomy was thequickest and least expensive. He also indicated that, in his opinion, some ofthe abdominal procedures could have been performed vaginally. Laparoscopic

Table A2.7 Retrospective studies—bed stay/costs (days/$)

Abdominal Vaginal Laparoscopic

Angle et al.(1995) US$ 4.0 4 550 3 529 2.5 8 137

Harris & Olive(1994) US$ 4.03 7 031 2.65 5 343 2.32 11 931

East (1994) NZ$ 4.30 2 255 3.30 1 650 2.78 4 467

Nezhat et al.(1994) US$ 3.3 4 926 3.0 4 868 2.3 7 161

Rosemann(1994) R 6 039 6 244 10 850

Jones & Lapsley(1994) AUS$ 5.9 4 024 not measured 2.1 4 325

Boike et al.(1993) US$ 4.5 10 551 3.8 7 884 2.5 12 469

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was found to be cheaper than abdominal only when non-disposable instrumentswere used. De Jong (1995) similarly found laparoscopic hysterectomy only alittle more expensive when using non-disposable instruments (7 557 versus6 771 Rand).

In examining costs, there are consistent differences between the retrospectivestudies and the two British randomised controlled studies comparing abdominaland laparoscopic hysterectomy in which stapling devices were also used. Partof the explanation may lie with the bigger difference in bed days between thegroups in the randomised controlled studies and the relatively reduced theatrecosts compared to the American studies. There were consistently large savingsmade when performing vaginal hysterectomy. While these are largely realsavings they may have been influenced in these retrospective studies by a biastowards the more simple vaginal operation. In East’s study (1994), the meanweight of uteri removed at vaginal operations was 87 grams compared to 236to 383 grams for laparoscopic and abdominal respectively.

Again it should be mentioned that no account had been taken of potentialcommunity savings associated with the earlier return to work in the laparo-scopic group. All these retrospective studies used the disposable staple guns.

A small Australian study by Jones and Lapsley (1994) similarly foundlaparoscopic hysterectomy to be more expensive than abdominal hysterectomybut associated with a shorter bed utilisation. Disposable staple guns were usedand, if the cost of these were removed from the itemised costings, the overallcosts favoured the laparoscopic operation. It must also be recognised thatutilising electrocautery or endoscopic suturing of the pedicles rather than adisposable stapling gun will lengthen theatre time and thus increase theoverall costs.

Subtotal versus laparoscopic assisted vaginal hysterectomyA recent editorial (Garry 1994b) and a commentary (Drife 1994) have refocusedattention on conservation of the cervix at hysterectomy. The issue of cervicalconservation at hysterectomy for benign bleeding disorders is particularlyrelevant as the cervix is usually found to be normal. For women with adocumented history of negative cervical cytology, the incidence of subsequentcervical cancer has been documented to be less than 0.3 per cent (Drife 1994).Cervical cancer can be further prevented by electrocoagulation or resection ofthe transformation zone to cervical canal in the remaining cervical stump.Other reasons for removing the cervix include the occurrence of cervical stumpprolapse, vaginal discharge, bleeding and dyspareunia. Potential advantagesfor cervical conservation are included in Table A2.8.

The laparoscopic approach to subtotal hysterectomy was first described bySemm (1993) and subsequently by Donnez and Nisolle (1993), Lyons (1993),Hasson (1993) and Ewen and Sutton (1994). The reason given for using thelaparoscopic subtotal approach is related to the perception that the operationis made easier, safer and quicker to perform. The above authors have notedoperating times varying from 60 to 188 minutes which seem comparable to mean

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operating times reported for laparoscopic assisted vaginal hysterectomy(64 minutes) (Phipps & Nayak 1993) and Doederlein hysterectomy (59 minutes)(Saye

et al. 1993).

In the past, removal of the uterus by morcellation or via a posterior colpotomyprolonged the subtotal operation. The ability to morcellate large quantities oftissue laparoscopically has been significantly improved with the introductionof electronic morcellators.

Sutton (1995), in studying an initial experience of 58 patients having laparo-scopic subtotal hysterectomy with removal of the transformation zone, foundthat the mean hospital stay was 2.8 days with return to full activity by 20 days.The mean operating time of 75 minutes compares favourably with abdominalhysterectomy. Apart from two cases of secondary haemorrhage, there were nomajor complications in this series. The same author’s case controlled study of50 patients having abdominal hysterectomy showed two uteteric and onebladder injury, an overall much higher morbidity rate and a six week timeinterval before return to full activity. However, the issue of length of convale-scence and ability to return to work are significantly influenced by the attitudeof the surgeon concerned and patient’s expectations of a prolonged convalescencewhich historically has been associated with laparotomy procedures.

There have been a number of studies comparing laparoscopic subtotal hysterectomywith laparoscopic assisted vaginal hysterectomy with the aim of demonstratinga reduced morbidity and faster recovery. Their findings are summarised inTable A2.8. Lyons (1993) compared 50 patients from each group, although theselection process was not discussed. He found a statistically significant differ-ence favouring the subtotal approach for operative time, blood loss, hospitalstay and return to work and normal activities. Likewise Schwartz (1993) andRichardson et al. (1995) noted improvements in hospital stays and return tonormal activities and work.

Schwartz (1993) retrospectively compared a group of subtotal operations with232 laparoscopic hysterectomies pooled from the literature and Richardson(1995) retrospectively reviewed two groups where patients were selectedaccording to their own preference. Both authors found increased operativetimes for the subtotal cases. Schwartz (1993) averaged almost four hours percase with the longest being more than seven hours. He gave no explanation asto why his operative times were so long. All authors used morcellation andremoval via the laparoscopic ports as the method of specimen retrieval.

Details of costings between the groups were not fully discussed. Lyons (1993)produced comparisons of costs between the two operations and abdominalhysterectomy with subtotal being cheapest and abdominal the most expensive($10 000 versus $12 000 versus $17 000 approximately). In contrast, Schwartz(1993) found laparoscopic subtotal to be more expensive than abdominalhysterectomy. Neither author gave details of how these estimates were reachedor where the abdominal hysterectomies which had not been previouslymentioned had come from.

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The studies were too small to make any meaningful comparison of complicationrates. There were no serious complications, with minor complicationsconsisting of febrile illness, inflammed trocar sites and nausea and vomiting.There were two cases of ongoing cyclical bleeding—a rate of 10 per cent whichis consistent with other reports in the literature. The other studies do notmention this problem. Lyons (1993) routinely ablated the endocervical canalwith laser or rollerball diathermy while the other two gave no treatment.

Overall the authors concluded laparoscopic subtotal hysterectomy to be a lessmorbid procedure when considering the improved operative stays and returnto normal activities. As further evidence, Schwartz (1993) found coitus wasresumed on average 10.2 days post-operatively, two patients resumed work onday two and three were driving by the same time. One patient was backjogging daily by day five. Richardson (1995) described decreased coitalfrequency and libido in the laparoscopic assisted vaginal hysterectomy groupas well as increased problems with vaginal discharge, back pain and bowel andbladder symptoms.

Table A2.8 Subtotal hysterectomy versus LAVH

Lyons (1993) Schwartz (1993) Richardson (1995)

LAVH LSH LAVH LSH LAVH LSH

Sample size 50 50 232 20 21 20

Patient selection not discussed literature retro-rv retro. pt. preference

Operating time(min) 145 118 185 229 117 127

Hospital stay 37 hrs 18 hrs 59 hrs 14 hrs 1.9 days 1.4 days

Return to work(days) 22.0 7.0 17.5 5.6 17.5 5.6

Return toactivity 14 3 not recorded not recorded

Complications 5 1 – nil 2 6

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Appendix 3

Appendix 3

Terms of reference, committee membership andcontributing authors

Terms of referenceThe Terms of Reference state that the Australian Health Technology AdvisoryCommittee Working Party on Minimal Access Surgery should:

1 Use laparoscopically assisted hysterectomy and herniorrhaphy as the initialcase-study procedures to:

• review the scientific literature and undertake systematic reviews on theselected case-study procedures to determine their benefits and risks.

2 Use the case-study procedures to consider in detail the following issuessurrounding minimal access surgery in Australia:

• appropriate case selection criteria;

• training requirements for surgical and non-surgical staff;

• devices and instrumentation;

• safety considerations;

• institutional requirements, including theatre facilities, equipment andback-up, staffing levels, day care and ward facilities;

• caseload requirements;

• procedures for monitoring and follow-up of patients during and aftersurgery;

• data collection;

• possibility of having cost effectiveness considered as part of theintroduction of minimal access surgery procedures.

3 Make recommendations to promote the appropriate application of minimalaccess surgery in Australia.

4 Use the case-study approach to develop a protocol for the assessment ofminimal access surgical procedures.

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Committee membership

Australian Health Technology Advisory CommitteeDr Brendon Kearney ChairDr Andrew Holmes Representative of the New Zealand Ministry of

HealthDr Terri Jackson Expertise in health economicsDr Craig Martin Nominee of the Australian Health Ministers’

Advisory CouncilMs Kathy Meleady Nominee of the Australian Health Ministers’

Advisory CouncilDr Timothy Nash Expertise in medical technology industryMs Penny Rogers Nominee of the Commonwealth Department of

Health and Family ServicesAssoc Prof John Simes Experience in researchDr David Waggett Expertise in biomedical engineeringAssoc Prof Evan Willis Nominee of Consumers’ Health ForumMs Geraldine Donohoe Secretary

Membership of the Working PartyDr Timothy Nash Chair, AHTAC member; expertise in the medical

technology industryProf David Fletcher Nominee of Committee of Presidents of Medical

CollegesMs Jill Hardwick Expertise in health economicsMr Leslie K Nathanson Nominee of Royal Australasian College of SurgeonsDr Oswald M Petrucco Nominee of Royal Australian College of Obstetricians

and GynaecologistsMs Penny Rogers AHTAC member; nominee of Commonwealth

Department of Health and Family ServicesDr John Waller Nominee of Royal Australian College of Medical

AdministratorsAssoc Prof Evan Willis AHTAC member; nominee of Consumers’ Health

Forum

Coopted memberDr Maggi Ryan Acting Director, Royal Australian College of

Obstetricians and Gynaecologists

Project supportMs Wendy Shephard AHTAC secretariat

Consultant writing and editingElizabeth Hall and Associates

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Authors of reports and literature reviews(in conjunction with the Minimal Access Surgery Working Party)LIHR case study report and literature reviewDr Carolyn Baigrie Project Officer, The Royal Adelaide Centre for

Endoscopic SurgeryDr David Watson Director, The Royal Adelaide Centre for Endoscopic

SurgeryAssoc Prof Peter Devitt University Department of Surgery, Royal Adelaide

HospitalProf Glyn Jamieson The Royal Adelaide Centre for Endoscopic Surgery

and the University Department of Surgery, RoyalAdelaide Hospital, South Australia

LAH audit report and literature reviewDr Oswald Petrucco Senior Lecturer, Department of Obstetrics and

Gynaecology, Royal Adelaide HospitalDirector of Gynaecology, Women’s and Children’sHospital, Adelaide

Dr David O’Callaghan Endosurgery Fellow, Mercy Hospital for WomenDr Maggi Ryan Acting Director, The Royal Australian College of

Obstetricians and Gynaecologists

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Appendix 4

List of consultation submissions

1 Dr Michael Jelly, South Australian Health Commission

2 Dr Bryant Stokes, Health Department of Western Australia

3 Dr CW Brook, Department of Human Services, Victoria

4 Dr MR (Taffy) Jones, Royal Australian College of Medical Administrators

5 Dr GJ Dobb, Australian and New Zealand Intensive Care Society

6 Ms Anne-Marie Scully, Australian Nursing Federation

7 Dr Dennis Smith, Australian Council on Healthcare Standards

8 Dr Hugh Torode, North Shore Medical Centre, Sydney

9 Prof NA Saunders, Flinders University of South Australia

10 Ms Elizabeth Percival, Royal College of Nursing, Australia

11 Dr CW Brook, member, NHMRC

12 Dr David Filby, South Australian Health Commission

13 Assoc Prof Peter J Maher, Australian Gynaecological Endoscopy Society

14 Dr Diana Lange, Queensland Health

15 Mr Robert O’Shea, Australian Gynaecological Endoscopy Society

16 Mr Colin McRae, Royal Australasian College of Surgeons

17 Mr Michael Reid, NSW Health Department

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Appendix 5

Appendix 5

Acronyms and abbreviationsAGES Australian Gynaecological Endoscopy Society

AHTAC Australian Health Technology Advisory Committee

AMA Australian Medical Association

CSSD Central Sterile and Supply Department

LAH laparoscopic assisted hysterectomy

LAVH laparoscopic assisted vaginal hysterectomy

LIHR laparoscopic inguinal hernia repair

MAS minimal access surgery

MBS Medicare Benefits Schedule

NHMRC National Health and Medical Research Council

QA quality assurance

PBS Pharmaceutical Benefits Scheme

RACOG Royal Australian College of Obstetricians and Gynaecologists

RACS Royal Australasian College of Surgeons

RCT randomised controlled trial

SAGES Society of American Gastrointestinal Endoscopic Surgeons

TAPP transabdominal preperitoneal prosthetic repair

TEP totally extraperitoneal

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RESCINDED

Minimal access surgery

124

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RESCINDED