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    Laparoscopic cholecystectomy in 1994

    Results of a prospective survey conducted by SFCERO* on 4,624 cases

    D. Collet

    Service de Chirurgie Generale et Digestive, Maison du Haut-Leveque, Avenue de Magellan, 33604 Pessac Cedex, France

    Received: 25 January 1996/Accepted: 10 April 1996

    Abstract.Background: In 1996, laparoscopic cholecystectomy is thegold standard for symptomatic cholelithiasis. The results ofhis operation as published so far include data on the learn-ng curve of the method. The aim of this study is to evaluatehe results of laparoscopic cholecystectomy when per-

    formed by a large number of surgeons during the year 1994,not taking into account the beginning years in which theechnique was being used.

    Methods: This study has been carried out prospectively and

    anonymously among members of SFCERO. All the patientswho underwent a cholecystectomy started laparoscopicallyduring 1994 have been included.Results: Some 4,624 cholecystectomies were performed by150 surgeons. There were 3,310 females (42.5 19.8 yearsold) and 1,314 males (56.3 1.61 years old). The conver-

    ion rate was 6.9%: 320 operations had to be converted intoaparotomy (group II) while 4,261 were performed entirely

    by laparoscopy (group I). Morbidity was 5% (N 230)4.7% in group I (N 203) and 8.4% in group II (N 27).Mortality was 0.2% (N 9)namely four intraabdominalcomplications (three cases of peritonitis and one biliary re-

    operation), two cardiac failures, and one brain infarction.The causes of death were not specified in two patients.Conclusions: These results show that morbidity and mor-ality have not changed dramatically since the beginnings ofhis technique, whereas the frequency of common bile ductCBD) injuries has decreased. However, the conversion rate

    has increased slightly. These results make it possible tocalculate the risk of conversion and postoperative compli-cation according to the age of the patient and the biliary

    ymptoms.

    Key words: Gallstones Cholecystectomy Surgery Laparoscopy Laparoscopic cholecystectomy

    After widelyand sometimes wiselycriticized begin-nings, after heated debates and the often-uncontrolled pub-licity through the media, laparoscopic cholecystectomy wasofficially recognized in 1994 as the treatment of choice for

    symptomatic gallbladder lithiasis [16]. Although its mor-bidity and mortality rates are similar to those of open cho-lecystectomy, it has the advantage of suppressing the draw-backs linked to open abdominal surgery: All previous stud-ies have pointed to a significantly shorter hospital stay,lesser postoperative pain, and earlier return to work [1, 2, 4,8, 1215, 17, 24, 2729, 31, 33, 3639].

    Yet, the only results published on this procedure so farhave come either from highly trained operating teams orfrom multicenter studies that took into account the learningcurve of the method. This possible bias may have given riseto a number of sometimes-exaggerated controversies or

    even rumors. This is why it seemed necessary, now that thistechnique has reached the stage of maturity, to evaluate itsresults among a large community of surgeons, thus provid-ing a sort of snapshot of it for the year 1994. This is theobjective of this study.

    Material and methods

    This survey has been carried out prospectively and anonymously. At thebeginning of the survey, the participating surgeons committed themselvesto supplying information about all the patients who would undergo lapa-roscopic cholecystectomy between January 1 and December 31, 1994. Aletter of reminder was sent out to them halfway through the year to boost

    their personal involvement.The form used to collect the data included the patients identity, the

    biliary symptoms, the technique used, the circumstances of the conversionif any, and finally, the postoperative course over 1 month. One separatepersonal form was completed for each of the patients and was sent anony-mously to the person in charge of the survey. Therefore, this is a prospec-

    SFCERO: Societe Francaise de Chirurgie Endoscopique et RadiologieOperatoire, dissolved in December 1994 to form the SFCEL (Societe Fran-

    aise de Chirurgie Endoscopique et Laparoscopique) in association withhe FDCL

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    ive consecutive series in which the methodology used does not allow oneo know the participants previous experience in laparoscopic surgery norhe number of patients who underwent a classical cholecystectomy duringhe same period of time.

    The data were collected into a Microsoft Access database. Incompleteor missing answers were not taken into account for the calculation ofpercentages. Therefore, the corresponding figures are mentioned in paren-heses.

    The degree of obesity was evaluated by the Body Mass Index (BMI):Weight (kg)/Size (m2). The normal values range from 20 to 30 kg/m2. Theobesity is classified as moderate from 30 to 35 kg/m2, and morbid beyond

    5 kg/m2.A statistical analysis was carried out on Statistica for linear and mul-

    iple regressions and on EGRET for logistical regressions. A value of p 0.0001 at each time point tested,ndicating that there is a statistically significant difference inime required to perform the task with hand control and withobot control at each time interval. Examination of the curve

    also reveals that after 6 min of practice in each condition thecurve levels off with very little improvement in time toperform the task. This indicates that the ability to control theaparoscope by robot or hand is learned at a nearly equalate for the two conditions and that both conditions areearned in approximately 6 min.

    Discussion

    The use of robotics includes stereotactic frames and retrac-ors in neurosurgery, femur preparation for total hip replace-

    ment in orthopedic surgery [5, 6], transurethral resection ofthe prostate in urologic surgery [9], and stapedotomy inotolaryngology. The advantages of robotics over humans inthe performance of surgery include greater three-dimensional spatial accuracy, more reliable and more re-peatable outcomes, and greater precision [2]. The AESOProbot is another advancement in the development of instru-ments available for the performance of laparoscopic proce-

    dures. It is cost effective because it decreases by one thenumber of personnel required to perform many laparoscopicprocedures. The learning curve, as demonstrated by thisstudy, is approximately 6 min, and use of the robot islearned as quickly as control of the laparoscope with manualcontrol. While manual control appears faster than robot con-trol in this study, this has not been found in clinical trialswhere experienced attending surgeons evaluated the deviceand found AESOP-assisted laparoscopic operations to befaster with an assistant holding the endoscope. This waspartially due to delays in image acquisition and partially dueto multiple lens smearings more frequent with a humanscope holder [3]. Most operative procedures require a con-sistent view of a small field. Changes in the operative fieldare usually small, and therefore, the difference in the time tochange position with the robot and with hand control be-comes negligible. The advantages of the AESOP robot arethat it provides a more consistent view, decreases the num-ber of personnel required to perform an operation, and mostimportantly, returns control of the operative field to theoperating surgeon.

    We plan to follow this study with further controlledrandomized trials using the robot. We intend to compare thetime required to perform more functional tasks such as in-tracorporeal suturing in a pelvic trainer and the time re-quired to perform procedures in the operating room.

    References

    1. Begin E, Gagner M, Hurteau F, de Santis S, Pomp A (1995) A roboticcamera for laparoscopic surgery: conception and experimental results.Surg Laparosc Endosc 5: 611

    2. Buckingham RA, Buckingham RO (1995) Robots in operating the-atres. Br Med J 311: 14791482

    3. Editorial (1994) Robotic arm returns direct scope control to surgeon.Minim Invasive Surg Nurs 8: 8788

    4. Gagner M, Begin E, Hurteau R, Pomp A (1994) Robotic interactivelaparoscopic cholecystectomy. Lancet 343: 596597

    5. Mittelstadt B, Paul HA, Taylor RH, Kazanzides P, Zahars J, William-son B, Petit R, Cain P, Kloth D, Rose L, Masits B (1993) Developmentof a surgical robot for cementless total hip replacement. Robotica 11:553560

    6. Paul HA, Bargar WL, Mittlestadt B, Musits B, Taylor RH, KazanzidesP, Zuhars J, Williamson B, Hanson W (1992) Development of a sur-gical robot for cementless total hip arthroplasty. Clin Orthop 285:5766

    7. Sackier JM, Wang Y (1994) Robotically assisted laparoscopic sur-geryfrom concept to development. Surg Endosc 8: 6366

    8. Satava RM, Simon IB (1993) Teleoperation, telerobotics, and tele-

    presence in surgery. Endosc Surg Allied Technol 1: 1511539. Timoney AG, Ng WS, Davies BL, Hibberd RD, Wickham JEA (1991)

    Use of robots in surgery: development of a frame for prostatectomy. JEndourol 5: 165168

    10. Unger SW, Unger HM, Bass RT (1994) AESOP robotic arm. SurgEndosc 8: 1131

    Fig. 1. Learning curve of acquisition of skills allowing control of theaparoscope using robotic and manual control over a 10-min practice time.

    Data is plotted as the mean plus or minus the standard deviation of themean.

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    Staple penetration and staple histological response for attaching anepimysial electrode onto the abdominal surface of the diaphragm using

    a laparoscopic approach

    B. D. Schmit,1 T. A. Stellato,2 J. T. Mortimer1

    Applied Neural Control Laboratory, Case Western Reserve University, C.B. Bolton Bldg. 3rd Floor, Cleveland, OH 44106-4912, USADepartment of Surgery, University Hospitals of Cleveland, 11100 Euclid Avenue, Cleveland, OH 44106, USA

    Received: 2 April 1996/Accepted: 12 June 1996

    AbstractBackground: Laparoscopic stapling was found to be a vi-able option for attaching epimysial electrodes onto the ab-dominal surface of the diaphragm. Stapling was preferableo suturing due to its simplicity and speed.

    Methods: Of the two staplers tested in this study, the Ethi-con Endopath was preferred over the Autosuture Endo Her-nia because the staples did not penetrate the diaphragmwhen an electrode tab thickness greater than 0.75 mm was

    used.Results: The thickness of the electrode tab was an importantfactor in determining staple penetration but large variationn penetration depth indicated that other factors may also

    play a role. An electrode tab thickness of 1.01.25 mm wasuggested to minimize the risk of diaphragm perforation.

    Conclusions: The histological reaction to staples implantedup to 14 months was unremarkable, reflecting the safety ofaparoscopic staples for permanently anchoring electrodes

    on the diaphragm.

    Key words: Epimysial approach Staple penetration

    Staple histological response.

    The objective of this study was to determine whether aaparoscopic stapler could be used to permanently attach an

    epimysial electrode onto the abdominal surface of the dia-phragm without risk of perforating the diaphragm. Epimy-

    ial electrodes attached to the diaphragm using staples maybe used for electrical activation of the diaphragm (dia-phragm pacing) to provide ventilation for patients who havediaphragm paralysis, yet intact phrenic motor units. This

    approach to diaphragm pacing poses little or no risk for

    phrenic nerve damage and is amenable to laparoscopic-assisted implant.

    Laparoscopic implant of electrodes on the abdominalsurface of the diaphragm reduces the risk of nerve damageassociated with phrenic nerve cuff electrodes [1618, 22].Cuff electrodes require placement directly on the phrenicnerves using a cervical or thoracic approach [8, 9, 26]. As aresult, the phrenic nerves are subject to surgical manipula-tion and mechanical trauma associated with the electrode[10]. In order to alleviate this risk, we developed a laparo-scopic procedure for implanting intramuscular electrodes inthe diaphragm [22]. This permits diaphragm pacing withoutphysical contact with the phrenic nerves and benefits fromthe advantages of laparoscopic surgery including acceler-ated recovery, rapid convalescence, reduced wound infec-tion, and facilitated surgery in the obese [3]. Intramuscularelectrodes are effective for producing ventilation in dogs[17], but Peterson et al. found that 12 of 30 implanted elec-trodes perforated the diaphragm and three of these extendedmore than 1 cm into the thorax [17]. The risks associatedwith transdiaphragmatic electrode placement include pneu-

    mothorax and placement of the stimulating tip in the heartor lungs.

    In this study, we tested epimysial electrodes, which can-not perforate the diaphragm, as an alternative to intramus-cular electrodes. This electrode type offers the additionaladvantage of an implant location that can be studied lapa-roscopically after attachment to the diaphragm. Two lapa-roscopic staplers, the Endopath (Ethicon Inc., Somerville,NJ) and the Endo Hernia (Autosuture Co., Norwalk, CT),were tested as an alternative to suturing epimysial elec-trodes in order to simplify the implant procedure. We hy-pothesized that when stapling an epimysial electrode onto

    the abdominal surface of the diaphragm, the staple penetra-tion would be determined primarily by the thickness of thestapled elementthe electrode tabs in this study. In a short-term study, we studied the risk of perforation of the dia-phragm and the short-term tissue response of the staples

    Correspondence to: Sensory Motor Performance Program, Rehabilitationnstitute of Chicago, 345 E. Superior Street, Room 1406, Chicago, IL

    60611, USA

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    from both of the tested staplers. The long-term tissue re-ponse and the staple penetration of the Endopath were alsoested. In both tests, we used staple penetration as an indi-

    cation of the risk of diaphragm perforation. The effect ofelectrode thickness on staple penetration was characterized

    and then implemented in the design of an epimysial elec-rode with a minimum danger of diaphragm perforation.

    Methods

    The Endopath and the Endo Hernia are disposable, multifire staplers de-igned for use in laparoscopic hernia repair [11, 15, 23]. The Endopath has rotating handle and contains 20 staples. The Endo Hernia has a rotating

    handle, an articulating head, and holds ten staples. The staples dischargedby each stapler are shown in four stages of closure in Fig. 1.

    One-week study

    A 1-week study was conducted to assess the risk of diaphragm perforationnd determine the effect of electrode tab thickness on staple penetration forach stapler. The histological response of the muscle to the staples was alsoharacterized after the 1-week implant.

    The stapler/staples were tested by attaching a simulated electrode tabSET) onto the diaphragm muscle under laparoscopy. The SET, shown in

    Fig. 2, was made of Silastic (MDX 4-4210 Dow Corning Corp.) with aDacron reinforcement. These implants were custom made with four dif-erent thicknesses0.50 mm, 0.75 mm, 1.00 mm, and 1.25 mma length

    of 19.1 mm, and a width of 12.7 mm. One polypropylene mesh (SurgiproSPM-35, U.S. Surgical Corporation) was also tested in one of the threemplants. Each SET was cleaned using a six-step cleaning process consist-ng of 5 min in a sonicator with the solvents Freon TMS, Safezone, Liqui-

    nox in distilled water, distilled water, 95% ethanol, and ultrapure water.Each implant was placed in a clean vial in ultrapure water and sterilizedusing gamma radiation.

    Eight SETs were implanted using aseptic technique in each of threedogs, weights 33, 27, and 38 kg. The dogs were preanesthetized withSurital (15 mg/kg), intubated, and shaved for surgery. Halothane anesthetic

    (12%) was used for the remainder of the implant procedure. The dogswere treated with 500 mg intravenous oxacillin at the beginning and end ofsurgery and cephalexin (500 mg, p.o. b.i.d.) for 3 days following surgery.Temperature was maintained using a heating pad and the dog was admin-istered 500 ml 0.9% sodium chloride intravenously over the course of theimplant procedure.

    Four SETs were stapled to the abdominal surface of each hemidia-phragm using a laparoscopic procedure. A 10-mm incision was made 13cm caudal to the umbilicus, and a Veress needle was inserted to establisha carbon dioxide pneumoperitoneum. A 10-mm trocar was inserted and a10-mm, 0 laparoscope was introduced. A 10/11-mm trocar and a 12-mm

    trocar were inserted 68 cm lateral and 35 cm rostral to the initial cannulaon opposite sides. Each SET was introduced through the 12-mm cannulaand a stapler through the 10/11-mm cannula. The SETs introduced on theright side were implanted on the right hemidiaphragm and vice versa,allowing a stapler approach from the contralateral cannula. The contralat-eral approach aided the stapling procedure by improving the stapler angle.

    Fig. 1. The Endopath (left) and Endo Hernia (right) staples. The staples arehown in open stage through two closing stages and in the final implantedonfiguration. The arcs traversed by the staple tips are demonstrated in thechematic below the photograph. Note that the point of maximum penetra-ion may be greater than the penetration at either the starting or final

    position of the staple. Also note tissue would be gathered through the area

    demarcated by the arc of the staple tines and compressed into the area offinal enclosure.

    Fig. 2. The silicone rubber test SET used for the short-term test of thestaples. Thickness was 0.50, 0.75, 1.0, or 1.25 mm.

    Fig. 3. The electrodes used for the long-term staple test. Type 1 electrodes(right) had a tab thickness of 0.88 mm; type 2 (middle), 0.60 mm; and type3 (left), 0.75 mm. The staples were placed through the tabs on either sideof the center disk. Two to three staples were implanted per electrode.

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    Following surgery, the dogs were X-rayed for pneumothorax. The ani-mals were housed for 6, 6, and 7 days. At the time of explant, two of thedogs were anesthetized with sodium pentobarbital (30 mg/kg) and an aortic

    whole body) perfusion was done (2 l 1% paraformaldehyde in 25 mMacodylate buffer with 0.9 mM MgCl

    2 6H

    2O followed by 4 l 3.5% glu-

    araldehyde in 25 mM cacodylate buffer with 0.9 mM MgCl2

    6H2

    O). Uponissue explant, the diaphragm was placed in 10% formalin. The third ani-

    mal was killed with an overdose of sodium pentobarbital and the dia-phragm muscle was excised and placed in 10% formalin.

    Tissue samples were cut from the diaphragm and staples were removed.Each tissue sample was sectioned along the longitudinal tract of the staple.Samples were dehydrated and embedded in paraffin. Slices 710 m thick

    were stained with Hematoxylin and Eosin. Staple penetration was mea-ured from images of the tissue section with a staple placed over the

    hypothetical staple tract (see Figs. 4 and 6). Images were then digitized andnalyzed using JAVA video analysis software (version 1.4, Jandel Scien-ific). Staple penetration, muscle thickness, reactive layer thickness, andross-sectional areas of obvious staple location were measured.

    Long-term study

    The Endopath was studied in a long-term study using the stapler to attachepimysial electrodes onto the abdominal surface of the diaphragm. Theability of the staples to hold a long-term implant in place was assessed andthe histological response to the staples was determined. Staple penetrationwas measured for the long-term study and the effects of electrode tabthickness on staple penetration were documented.

    Three electrode designs (Fig. 3) were tested in a total of 11 dogs. Eachdog was implanted with two to four electrodes that remained implanted fora minimum of 3 months. Each electrode type had a lead wire terminating

    in a disk, 6.4 mm in diameter. Electrode type 1 incorporated a stimulatingsurface located in a well formed by a Dacron-reinforced Silastic (MDX4-4210) housing. Electrode types 2 and 3 incorporated a protruding hemi-spherical stimulating surface. Stapling tabs (12.7-mm diameter) were lo-cated on opposite sides of the center disk. Electrode type 2 did not haveDacron reinforcement while Dacron reinforcement was added to the ab-

    Fig. 4. Tissue sample from 1-week study. A perforated diaphragm from anEndo Hernia stapler through a 1.25-mm SET. A view of the sectional viewof the diaphragm is shown in A. The abdominal surface of the diaphragmis shown on the top. Note tissue gathering by the staple upon closure. Astaple is superimposed on the same tissue section, shown in B. The stapletines were located partly on the thoracic side of the diaphragm. Largermagnification of the tissue response is shown in C. There were no viablemuscle fibers in the immediate vicinity of the staple. An inflammatoryresponse extended from the abdominal surface through to the thorax in-cluding fibrin, active macrophages, and fibroblasts. The histology wasconsistent with a normal inflammatory response.

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    dominal side of type 3 electrodes. The stapling tab thicknesses were 0.88mm (type 1), 0.60 mm (type 2), and 0.75 mm (type 3). Each electrode was

    leaned using a six-step cleaning process as described in the short-termtudy. Each electrode was sterilized by autoclave (type 1) or ethylene oxide

    gas (type 2 and type 3). A 2-week degassing period was allowed forthylene-oxide-sterilized electrodes.

    The electrodes were implanted under laparoscopy as described in thehort-term study. One to two electrodes were implanted on each hemidia-

    phragm. Two to three Endopath staples were used to fix each electrode

    onto the muscle. Lead wires to the electrodes exited the peritoneum at thexiphoid and traversed subcutaneously to an exit point on the back of the

    nimal, midway along the scapula. The anesthesia, antibiotic regimen, andupportive care were identical to the 1-week test.

    Routine biweekly stimulation tests of supine anesthetized dogs wereonducted for the duration of the study. These tests consisted of cyclictimulation (2.55-s cycle time, 1.01.5-s inspiration time) of each elec-rode for periods of less than 1 h (type 1 and type 3) or for 15 h (type 2).

    Stimulation levels ranged from subthreshold to full recruitment with stimu-ation frequencies of 840 Hz. Type 1 electrodes were also stimulated upo 22 h/day between the biweekly tests with a 5-s cycle time, 1.5-s inspi-ation time using 20-Hz, current-controlled, charge-balanced, biphasic

    pulses with a 20-mA amplitude, 100-s pulsewidth, and 100-s delaybetween phases. Stimulation was applied simultaneously to one electrodeon each hemidiaphragm, using the electrodes providing the greatest re-

    ruitment.Prior to explant, the electrodes were again viewed under laparoscopy to

    valuate gross tissue reaction. Type 1 and type 3 electrodes were explanted months after implant and type 2 electrodes were explanted 714 monthsfter implant. Each dog was anesthetized with sodium pentobarbital (30

    mg/kg) and placed in the supine position. After the laparoscopy, the dogwas euthanized with an overdose of sodium pentobarbital and the dia-

    phragm was excised. The muscle was fixed in 10% formalin for a mini-mum of 7 days.

    Tissue samples were sectioned along the staple tract and the staple wasremoved. Muscle sections were dehydrated, embedded in paraffin, andsliced (710 m thick) for light microscopy. One set was stained withHematoxylin and Eosin and another with Massons Trichrome. Slides werestudied under light microscopy and images were digitized and analyzedwith JAVA image analysis software. Staple penetration, muscle thickness,reactive layer thickness, and areas of obvious staple location were mea-sured.

    Results

    One-week study

    SETs attached to the diaphragm using the Endo Hernia sta-pler resulted in perforation of the diaphragm in nine of the11 samples including the thickest (1.25 mm) SET. Thepostimplant X-rays indicated that each dog in the 1-weekstudy incurred a pneumothorax. A muscle section of a dia-

    phragm that was perforated is shown in Fig. 4. The tissuereaction to the Endo Hernia staple was characterized by noviable muscle within the staple opening and an active for-eign body response. The data are summarized in Table 1.

    The staple penetration data and corresponding SETthickness for the Endopath staples are shown in Table 2.None of the 11 Endopath staples perforated the diaphragm.When staple depth was plotted vs SET thickness, the plot inFig. 5 was found. A significant trend was not present whentesting the linear regression slope against zero. No signifi-cant staple depth difference was found even comparing thepenetration using thinnest SET (0.50 mm) to the thickest

    SET (1.00 mm) using a Wilcoxon rank sum test. SETs ofthickness 1.25 mm were not used because they could not bestapled to the diaphragm using the Endopath stapler.

    A typical 1-week tissue response to the Endopath stapleis shown in Fig. 6. The response was characterized by re-generating muscle cells and acute inflammatory cells such

    Table 1. Staple penetration data for the Endo Herniaa

    Dog SET thickness (mm) Complete penetration?

    75 0.35 Yes75 0.50 Yes75 0.75 Yes75 1.00 Yes

    645 0.75 Yes645 1.00 Yes645 1.25 No646 0.75 No646 1.00 Yes646 1.25 Yes646 1.25 Yes

    Penetration distance was not measured, but the table indicates whetheromplete penetration of the diaphragm was detected on the histologicalections. Complete penetration was defined as an active tissue responsehat extended from the peritoneum to the pleura. Nine of 11 samplesompletely penetrated the diaphragm. Interestingly, one of the nonpen-trating samples occurred with a 0.75-mm simulated electrode tab (SET),

    which was not the thickest sample size

    Table 2. Staple penetration and SET thickness of the 1-week staple test forhe Endopath

    Dog Mesh thickness (mm)Staple penetration (mm)/muscle thickness (mm)

    75 0.50 2.25/2.4875 0.50 1.40/2.2575 0.75 1.28/4.5875 1.00 1.06/2.90

    645 0.50 1.38/3.53645 0.50 0.86/2.70645 0.75 1.82/2.44646 0.50 1.75/2.56

    646 0.75 1.33/3.02646 0.75 1.33/2.90646 1.00 1.45/2.29

    Fig. 5. Staple penetration vs SET thickness for the 1-week study. Therewas no apparent relation between staple penetration and SET thickness.

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    as polymorphonuclear leukocytes and macrophages. Addi-ionally, fibroblasts were present and active. The most re-

    markable feature of the tissue response was viable muscle inhe enclosed portion of the staple. There was no indication

    of damage to many of these fibers. Tissue damage wasocated primarily inferior to the location of the staple wherehe staple apparently passed through the muscle during thetapling process.

    Long-term study

    The staple penetration data for the long-term study arehown in Table 3. For calculation of the mean staple pen-

    etration, each datum was weighted by the staple area found

    Table 3. Staple penetration for the long-term staple testa

    Electrodetype

    Meanpenetration(mm)

    STDerror

    STDdev n

    Tabthickness

    1 1.40 0.07 0.33 37 0.882 2.62 0.31 1.19 20 0.603 1.66 0.08 0.25 21 0.75

    a The electrode types are described in the text. Electrode types 1 and 3 wereimplanted for 3 months and electrode type 2 was implanted for 714months. The n value indicates the number of staples tested for each elec-trode type. Staple penetration was calculated from histological slides of thestaple tracts. The penetration for each sample was measured as the maxi-mum penetration measured using a hypothetical staple location. The meanpenetration was found using an arithmetic mean with a weight factor. Theweight factor was determined by the area of staple tract present in thehistological section

    Fig. 6. Tissue reaction to the Endopath staple at 6 days postimplant. Themuscle section, extending from abdomen to the thorax, is shown in A. Incontrast to the muscle section of the Endo Hernia staple shown in Fig. 4A,viable muscle fibers passed through the staple opening. The staple, super-imposed on the histological section in B, did not completely penetrate thediaphragm. Higher magnification of the tissue response is shown in C. Thenature of the tissue response was similar to the Endo Hernia but waslimited to regions near the staple, particularly beneath the staple tines. Thislocation was associated with the region of muscle that the staple passedthrough during closure.

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    n the histological cross section. The mean staple penetra-ion was 1.40 mm for electrode type 1 (thickness 0.88

    mm), 2.62 mm for electrode type 2 (thickness 0.57), and1.66 mm for electrode type 3 (thickness 0.75 mm). The

    tandard deviation was 0.33 mm (24%) for type 1 elec-rodes, 1.19 mm (45%) for type 2 electrodes, and 0.25 mm15%) for type 3 electrodes. The large standard deviation forhe type 2 electrodes was partly attributed to the complete

    penetration of the diaphragm of five staples. When compar-ng only the electrodes implanted for 3 months, electrodeype 3 was found to penetrate to a significantly greater depthhan electrode type 1 (p < 0.02, Students t test). A com-

    parison of these data is shown in Fig. 7. The mean musclehickness was 4.02 mm with standard deviation of 1.13 mm.

    The relation between staple penetration and tab thick-ness for the long-term electrode test is shown in Fig. 8. Ainear regression line with slope 4.25 (mm penetration)/mm tab thickness) was fit to the data. An effect test indi-

    cated that the tab thickness had a significant effect on staplepenetration (p < 0.0001).

    A typical long-term tissue response is shown in Fig. 9.The muscle surface reaction is primarily a reaction to the

    ilicone rubber electrode. The response to the staple wascharacterized by a thin layer of mature collagen along the

    taple tract with little evidence of a cellular reaction.

    Discussion

    Laparoscopic stapling was effective for attaching epimysialelectrodes onto the abdominal surface of the diaphragm.This conclusion is based on the long-term tissue response tohe staples and the absence of diaphragm perforation when

    using electrode tab thicknesses greater than 0.75 mm. Staplepenetration was the primary criterion for determining thesafety of a laparoscopic electrode implant because it wasdirectly related to the likelihood of diaphragm perforationand concomitant risk of inducing a pneumothorax. Thethickness of the electrode tab was found to be an importantfactor in determining staple penetration but could not ac-count for all variability in penetration depth. These data maybe important for determining staple penetration risks asso-ciated with other surgical procedures such as staple repair ofdiaphragmatic hernias [6, 14].

    The Endopath stapler was preferred over the Endo Her-nia for stapling electrodes onto the diaphragm because oflower incidence of diaphragm perforation using stapling padthicknesses between 0.5 mm and 1.25 mm. Nine of 11 EndoHernia staples completely penetrated the diaphragm in the1-week study compared to no diaphragm perforation for anyof the 11 Endopath staples. We postulated that the higherrisk of diaphragm perforation observed with the Endo Her-nia occurred because of a greater penetration of the stapletines during staple closure (Fig. 1). As a result, only theEndopath staples were tested in the long-term study.

    The incidence of diaphragm perforation in the long-termstudy was limited to five of 16 staple implants using thethinnest electrode tab (0.60 mm). Conversely, none of the58 staples used for stapling electrode tabs thicker than 0.75mm resulted in perforation of the diaphragm. Thus, al-though a risk of diaphragm perforation existed with Endo-path stapling, this risk was controlled by using a relatively

    thick electrode tab to limit the staple penetration. We con-cluded that the thickest possible electrode tab that still en-ables stapling should be used to minimize the risk of dia-phragm perforation. This dimension was between 1.0 and1.25 mm for the Endopath stapler.

    Fig. 7. Comparison of electrodes implanted for 3 months. The penetration is shown on the y-axis, and the electrode type on the x-axis. Electrode type 1has a recessed stimulating surface and a tab thickness of 0.88 mm. Electrode type 3 has a protruding stimulating surface and a tab thickness of 0.75 mm.

    The staple penetration for all the samples is displayed. The circles represent the means with the corresponding standard error of the mean. Standarddeviations are shown as dotted lines. The mean penetration for electrode type 3 was significantly greater than the mean penetration for electrode type 1p < 0.02, Students t test).

    Fig. 8. Relation between staple penetration and tab thickness for all long-term electrode tests. A line with slope 4.25 (mm penetration)/(mm tabhickness) was fit to the data. The tab thickness had a significant effect on staple penetration (effect test, p < 0.0001). The mean diaphragm thickness was

    4.02 mm 1.13 mm (standard deviation).

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    A significant correlation between staple penetration andSET thickness could not be demonstrated for the 1-week

    tudy, but a strong correlation was found for the long-termtudy. The difference between the tests was attributed to the

    variation in staple penetration and the small sample size forhe 1-week study. For the long-term study, linear regression

    of the staple penetration as a function of electrode tab thick-ness yielded a slope of 4.25 (Fig. 8), indicating that a smallncrease in electrode tab thickness caused a large decreasen staple penetration. We had hypothesized that the change

    n penetration would be inversely related to tab thicknesswith a slope of 1. The larger magnitude of the slope in thedata implies that the staple penetration was not limited byhe back of the staple (opposite the tines) pressing againsthe electrode in the final closed position.

    In addition to the thickness of the electrode tab, otherfactors influenced staple penetration. For each electrode tabthickness, the mean staple penetration was less than themean thickness of the diaphragm. Variation was observedfor both the staple penetration data and the diaphragm thick-ness (Fig. 8), and diaphragm perforation occurred whenparticularly deep staple penetration coincided with a thindiaphragm. The variation in staple penetration could not beentirely accounted for by differences in electrode tab thick-ness. Other factors determining staple penetration may have

    included conditions associated with the surgery such as sta-pler angle, the pressure placed against the electrode duringstapling, or the speed of staple closing. However, all stapleswere implanted using the same surgical protocol and by thesame investigator. The variation in staple penetration ad-

    Fig. 9. Tissue reaction to long-term staple test. This sectionwas sampled 14 months after implant and stained for col-lagen with Massons Trichrome. Note in A that a collagenmatrix was formed around the electrode tab implant. Thestaple tract, illustrated by superposition of a staple on thehistological section in B, was easily identified in this sec-tion. Higher magnification of the staple tract is shown in C.There was a thin layer of mature collagen lining the stapletract and viable muscle fibers within the staple opening.There was no evidence of an active tissue response near thestaple tract.

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    equately reflected individual differences associated thetaple implant procedure.

    Characterization of staple penetration may be importantfor other applications of laparoscopic staplers. The Endo-path and Endo Hernia staplers were designed specificallyfor fixing a prosthetic mesh for inquinal hernia repair and

    tapling the peritoneum over the preperitoneal mesh in theame operation [11, 15, 23, 24]. Other staple devices have

    also been used for this procedure including a linear cuttingtapler [2] and a laparoscopic clip applier [1, 5, 25], origi-nally designed for ligation of the cystic duct for the lapa-oscopic colecystectomy [21]. In addition to laparoscopicnguinal hernia repair, the Endopath and Endo Hernia have

    been used for a number of other applications. Stapling aprosthetic mesh over hernias of the diaphragm, such as aherniation at the foramen of Morgagni [14] and extremecases of paraesophageal hernia, have been accomplished6]. In addition, abdominal wall hernias have been repaired

    using a prosthetic mesh and the Endo Hernia [12]. TheEndopath has been used to reinforce a suture line in theepair of a diaphragmatic laceration [13] and for stapling the

    omentum to the gastric antrum, duodenum, and falciformigament for repair of a perforated duodenal ulcer [4]. The

    Endopath has also been used to repair gastric lacerationshigh on the fundus with an omental patch stapled over thegastric staple repairs [7]. The wide variety of potential ap-plications for single-staple devices which do not require ananvil for staple closure illustrates the versatility of thesedevices. As other laparoscopic procedures evolve, devices

    uch as the Endopath and Endo Hernia may be used formany other specific applications. However, the applicabilityof a laparoscopic stapler requires knowledge of the charac-eristics of the stapler, the implanted staple, and the nature

    of the implant. We have characterized one parameter, staplepenetration of the Endopath stapler, specifically for im-planting epimysial electrodes onto the diaphragm. Manyother parameters from different stapling devices may needo be characterized prior to choosing the appropriate instru-

    ment for new procedures. For example, the breaking oropening strength of the Endopath and Endo Hernia staplershas been studied to determine maximum loading for theaparoscopic inguinal hernia repair [19]. The histologicalesponse to the staples was one of the other staple param-

    eters studied to determine the propriety of the Endopathtapler for attaching electrodes onto the abdominal surface

    of the diaphragm.The histological response to the Endopath staples was

    adequate for long-term anchoring of an epimysial electrodeonto the surface of the diaphragm. The Endopath stapleswere nonstrangulating and non-necrosing as evidenced byhe viable tissue observed in the enclosure of the staple inhe 1-week test. Despite a significant cellular tissue re-ponse to the electrode tabs [20] (see also Fig. 9), the tissueeaction to the staples themselves was only one to two cellayers in thickness. In some cases the electrode tab tissueeaction obscured the histological response to the staple,

    especially for staples with small muscle penetration. The

    mall amount of tissue reaction to the staples is especiallyemarkable considering the Silastic material did not elicit aissue reaction capable of adhering the electrode tab to theurrounding tissue. This resulted in a transfer of stresses

    from the electrode to the staple and the tissue in proximity

    with the staple and thus, the staple was the important fix-ating device. The absence of a cellular reaction in the stapletracts observed in the long-term study demonstrated the me-chanical stability and biocompatibility of the staples.

    In conclusion, the applicability of the Endopath staplerfor attaching epimysial electrodes to the abdominal surfaceof the diaphragm has been confirmed. The safety of thestapler was demonstrated by measuring and controlling the

    staple penetration and by examining the histological re-sponse to the implanted staples.

    Acknowledgment. This work is supported by the Department of VeteransAffairs. We are grateful to Autosuture Co. for the donation of the EndoHernia staplers and to Ethicon for the Endopath staplers used in this study.We thank Karl Storz Co. for the use of the laparoscopic equipment and theFES Core Laboratory at CWRU for the use of equipment for electrodefabrication. We also thank Dr. Roessmann of the Department of Pathology,University Hospitals of Cleveland, for his assistance with the histology.

    References

    1. Campos L, Sipes E (1993) Laparoscopic hernia repair: use of a fenes-trated PTFE graft with endo-clips. Surg Laparosc Endosc 3: 3538

    2. Corbitt JD (1991) Laparoscopic herniorrhaphy. Surg Laparosc Endosc1: 2325

    3. Cushieri A (1991) Minimal access surgery and the future of interven-tional laparoscopy. J Surg 161: 404407

    4. Darzi A, Cheshire NJ, Somers SS, Super PA, Guillou PJ, Monson JRT(1993) Laparoscopic omental patch repair of perforated duodenal ulcerwith an automated stapler. Br J Surg 80: 1552

    5. Dion YM (1993) Laparoscopic inguinal herniorrhaphy. Surg LaparoscEndosc 3: 451455

    6. Edelman DS (1995) Laparoscopic paraesophageal hernia repair withmesh. Surg Laparosc Endosc 5: 3237

    7. Frantzides CT, Ludwig KA, Aprahamian C, Salaymeh B (1993) Lap-

    aroscopic closure of gastric stab wounds: a case report. Surg LaparoscEndosc 3: 63668. Glenn WWL, Phelps ML (1985) Diaphragm pacing by electrical

    stimulation of the phrenic nerve. Neurosurgery 17: 5665779. Glenn, WWL, Hogan JF, Loke JSO, Ciesielski TE, Phelps ML, Rowed-

    der R (1984) Ventilatory support of the conditioned diaphragm inquadriplegia. New Engl J Med 310: 11501155

    10. Glenn WWL, Brouillette RT, Dentz B, Fodstad H, Hunt CE, KeensTG, Marsh HM, Pande S, Piepgras DG, Vanderlinden RG (1988)Fundamental considerations in pacing of the diaphragm for chronicventilatory insufficiency: a multi-center study. PACE Pacing ClinElectrophysiol 11: 21212127

    11. Klein SR, Velez M, Davis IP (1992) Endoscopic hernia repair. UnitedStates Surgical Corporation, Norwalk, CT

    12. LeBlanc KA, Booth WV (1993) Laparoscopic repair of incisional

    abdominal hernias using expanded polytetrafluoroethylene: prelimi-nary findings. Surg Laparosc Endosc 3: 3941

    13. Marks JM, Ramey RL, Baringer DC, Aszodi A, Ponsky JL (1995)Laparoscopic repair of a diaphragmatic laceration. Surg Laparosc En-dosc 5: 415418

    14. Newman L, Eubanks S, Bridges WM, Lucas G (1995) Laparoscopicdiagnosis and treatment of Morgagni hernia. Surg Laparosc Endosc 5:2731

    15. Peters JH, Ortega AE (1993) Laparoscopic inguinal hernia repair. In:Minimally invasive surgery. McGraw-Hill, New York, Health Profes-sions Division pp 297308

    16. Peterson DK, Nochomovitz ML, DiMarco AF, Mortimer JT (1986)Intramuscular electrical activation of the Phrenic nerve. IEEE TransBiomed Eng 33: 342351

    17. Peterson DK, Nochomovitz ML, Stellato TA, Mortimer JT (1994)

    Long-term intramuscular activation of the Phrenic nerve: efficacy as aventilatory prosthesis. IEEE Trans Biomed Eng 41: 11271135

    18. Peterson DK, Nochomovitz ML, Stellato TA, Mortimer JT (1994)Long-term intramuscular activation of the Phrenic nerve: safety andreliability. IEEE Trans Biomed Eng 41: 11151126

    19. Powell JJ, Murray GD, ODwyer PJ (1994) Evaluation of staples and

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    prosthetics for use in laparoscopic inguinal hernia repair. J LaparoscSurg 4: 109112

    20. Schmit BD, Mortimer JT (1996) The tissue response to epimysialelectrodes for diaphragm pacing in dogs. (in press)

    21. Spaw AT, Reddick EJ, Olsen DO (1991) Laparoscopic laser chole-cystectomy: analysis of 500 procedures. Surg Laparosc Endosc 1: 27

    22. Stellato TA, Peterson DK, Nochomovitz M, Mortimer JT, Rhodes RS(1985) Diaphragm activation with laparoscopically placed intramus-cular electrodes in dogs. Surg Forum 36: 297299

    23. Toy FK, Smoot RT (1992) Toy-Smoot laparoscopic hernioplasty. DelMed J 64: 2328

    24. Voeller GR, Mangiante EC, Britt LG (1993) Preliminary evaluation oflaparoscopic herniorrhaphy. Surg Laparosc Endosc 3: 100105

    25. Watson SD, Saye W, Hollier PA (1993) Combined laparoscopic in-carcerated herniorrhaphy and small bowel resection. Surg LaparoscEndosc 3: 106108

    26. Wetstein L (1987) Technique for implant of phrenic nerve electrodes.Ann Thorac Surg 43: 336339

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    Laparoscopic hernioplasty:

    Why does it work?

    E. L. Felix, C. A. Michas, M. H. Gonzalez Jr.

    The Center for Hernia Repair, 6191 North Fresno Street, Suite 102, Fresno, CA 93710, USA

    Received: 2 April 1996/Accepted: 7 June 1996

    AbstractBackground: To understand how laparoscopic hernioplastyprevents early recurrence of hernia, we reviewed our first1,000 patients. We analyzed the patients by age, sex, andhernia type and by whether their hernia was primary orecurrent.

    Methods: The 1,000 patients had 1,336 hernias repaired byhe transabdominal preperitoneal or the totally extraperito-

    neal approach. One thousand one hundred seventy-threehernias were primary and 163 were recurrent. The type ofhernia found varied with the patients age (p < 0.001), and

    with whether the hernia was primary or recurrent (p

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    Patients undergoing the TAPP procedure had a 10/11-mm port placedn the umbilicus and one lateral to the inferior epigastric vessels on eitheride. The peritoneum was opened above the hernia defects and the posterior

    wall of the groin was dissected. A single-layer or double-buttress mesh

    epair of the entire floor was performed and the peritoneum was closedompletely over the mesh.

    The totally extraperitoneal technique used three trocars placed in themidline. The extraperitoneal dissection was initiated with a balloon dis-

    ector and completed manually. A single sheet of mesh without a slit wasused to cover the entire floor. The medial portion of the mesh was cut widerhan the lateral part so that the medial mesh extended well above the directloor and below Coopers ligament. If the testicular vessels prevented the

    mesh from lying flat over the lateral space, a double-buttress technique washosen. As in TAPP repairs, the mesh was anchored to the posterior floor

    of the groin with staples.Patients were discharged from the recovery room when they were able

    o ambulate on their own. No restrictions were placed on the patientsduring the postoperative recovery period, and they were encouraged toeturn to normal activity and work as soon as they felt comfortable. Patients

    were evaluated by physical examination and interview at 1 week, 6 months,nd yearly.

    All data obtained at surgery and follow-up examinations were prospec-ively recorded in a File Maker Pro computer database. Groups were com-

    pared statistically with Microsoft Excels chi test. Historical comparisonswere made from a review of the literature.

    Results

    One thousand three hundred thirty-six hernias were laparo-scopically repaired in 1,000 patients. Three hundred thirteen

    patients had simultaneous bilateral repairs and 23 hadstaged bilateral repairs. Two laparoscopic approaches to theposterior floor of the groin, the transabdominal preperito-neal and the totally extraperitoneal, were used and twomethods of mesh repair were used in each group (Fig. 4).

    There were 919 male and 81 female patients. The age ofthe patients ranged from 13 to 93 with a mean of 49 years(Fig. 5). Eleven hundred seventy-three hernias repairedwere primary and 163 were recurrent. Seven hundredninety-nine hernias were indirect, 309 direct, 16 femoral,212 pantaloon, and 69 hernias had an additional femoralcomponent. The type of hernia found was related to the age

    of the patients (p < 0.001) (Fig. 6) and to whether the herniawas primary or recurrent (p < 0.001) (Fig. 7). Twenty-sevenpercent of recurrent hernias were complex, compared to14% of primary hernias (Fig. 8). There was no significantdifference in type of hernia or in age or sex of patients

    Fig. 1. A view of the posterior wall of the groin as seen in the TAPPapproach (IPT, iliopubic tract; IH, indirect hernia; DH, direct hernia; P,

    peritoneum; VD, vas deferens; FR, femoral ring; TV, testicular vessels;CL, Coopers ligament; IE, inferior epigastric vessels).

    Fig. 2. A view of the posterior wall of the groin as seen in the TEPapproach (IPT, iliopubic tract; IH, indirect hernia; DH, direct hernia;VD, vas deferens; FR, femoral ring; TV, testicular vessels; CL, Coopersligament; IE, inferior epigastric vessels).

    Fig. 3. Polypropylene mesh anchored to the posterior wall covering allthree potential hernia defects: indirect, direct, and femoral (ST, staples).

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    One patient developed a small-bowel obstruction which wasepaired laparoscopically on the 3rd postoperative day, and

    one patient was explored for a trocar injury of the smallbowel on the 1st postoperative day. Six patients developed

    a trocar hernia and all have undergone an open repair.

    Comments

    nguinal hernia repair is one of the most common operationsn the United States [4]. The number of procedures per-

    formed annually has risen to almost 750,000 [21]. There hasbeen, however, no one approach which has been accepted ashe standard, but rather several which vary according tondividual surgeons biases [16]. Despite a gradual evolu-ion in technique, overall recurrence rates in the United

    States remained at approximately 10% [2, 21]. Lichtenstein

    et al. [12], Stoppa et al. [31], Nyhus et al. [15], and Wantz35] stressed the importance of reducing tension and rein-

    forcing intrinsic weakness of the groin to prevent recur-ence. In centers specializing in hernioplasty, where atten-ion was paid to these underlying causes of failure and to

    limiting technical errors by increasing individual surgeonsoperative experience, the incidence of recurrence was re-duced [3, 26, 28].

    Over the last few years, a laparoscopic approach hasevolved based on the open posterior repair [6, 11, 14, 34].The approach was designed to reduce postoperative re-covery and still address the causes of failure. It reducestension and reinforces intrinsic weakness by using a mesh-buttressed approach similar to that of Stoppa [32]. In addi-tion, the technique gives surgeons an overview of the entireposterior wall of the groin. It may be this magnified wide-angle exposure of the groin floor that distinguishes the lap-aroscopic technique from other mesh-reinforced repairs, aswell as open posterior repairs.

    Our laparoscopic examination of 1,000 patients foundthat 14% of primary and 27% of recurrent hernias were

    pantaloon, and up to 11% of hernias repaired had a femoralcomponent along with a primary defect (Fig. 10). Our find-ings were in contrast to those of several reviews that utilizedan open technique [7, 10, 13, 20, 2325, 28]. These inves-tigators either failed to comment on whether patients had a

    Fig. 7. The graph compares the percent of indirect, direct, pantaloon, andemoral hernias found in primary and recurrent repairs.

    Fig. 8. The graph compares by age the percent of complex hernias foundt operation in patients with a primary or recurrent hernia.

    Fig. 9. The graph shows the number of hernias repaired by a TAPP or TEPapproach per year over the 4 years of the study.

    Fig. 10. The graph compares by age the percent of hernias repaired thathad a femoral hernia in addition to a indirect, direct, or pantaloon inpatients with a primary or recurrent hernia.

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    complex hernia (a hernia with more than one defect in thewall), or, when complex hernias were identified, the overallncidence of these combined direct, indirect, and femoral

    hernias was low. Table 1 details six of these reports. Thencidence of complex hernias identified in these reports was

    much lower than we found using a laparoscopic approach.Why were so many more complex hernias found in our

    tudy? The answer would have to be that either our popu-ation of patients was different than those in previous stud-es or we are better able to identify the defects in the ingui-

    nal floor of our patients. If the latter is true, one must sus-pect that the view given us by the laparoscope wasesponsible for our success.

    If hernias are more complex than previously appreci-ated, we would expect early recurrence rates to be increasedwhen elements of the hernia are overlooked. In Post-ethwaits experience, 24% of indirect recurrent hernias

    were caused by a missed hernia [20]. Ryan [24] found asmany as 17% of all recurrent hernias were due to misseddefects at the original operation. The laparoscopic viewmight be key in improving our level of early success. Thiss particularly true in older patients and those with recurrent

    hernias. The incidence of complex hernias (pantaloon her-nias or hernias with an additional femoral component) in-creased with patients age and with whether the hernia hadpreviously been repaired. The ability of the laparoscopicapproach to expose these otherwise-occult defects might bepart of the reason for our techniques success.

    Recurrences due to missed hernias tend to present earlyn the postoperative period [7, 20, 24]. In Shultzs et al. [29]

    first report of laparoscopic repairs, there was an extremelyhigh incidence of early failures. Almost 25% of repairsecurred, because his technique limited dissection of the

    groin and failed to identify the second component of pan-aloon hernias which were present. This flaw in techniqueesulted in missed hernias and did not take advantage of theaparoscopic exposure. In a subsequent study by Shultz et

    al. [30], in which the entire floor was exposed, recurrenceswere totally eliminated. The low incidence of early failuresn our review, less than 1% after a median follow-up of 2

    years, may have in part been due to the ability of the lap-aroscopic technique to find and repair all components of thehernia. A complete dissection of the entire posterior wall ofhe groin was performed in all but one patient. The dissec-ion in this patient was impossible because mesh placed at

    an earlier operation at another institution prevented dissec-ion of the medial wall. A direct component of a pantaloonecurrence was missed and the repair failed.

    Technical error, the other reason for early recurrence24], was the cause of the other failures seen in our study.

    The Shouldice Clinic [3] has shown that the key to prevent-ing technical errors with an anterior approach is experience.We must assume that this will be the case for laparoscopictechniques. Learning curves have already been demon-strated for other laparoscopic procedures such as cholecys-tectomy [9].

    It appears that our laparoscopic technique was success-ful over the short term because it eliminated one of the main

    causes of early recurrence, missed hernias [20, 24]. It shouldcontinue to work over the long term, because it reducestension [27] and buttresses intrinsic collagen deficits [17],the causes of late recurrence. The key to maintaining such alow recurrence rate will be the avoidance of technical errors.Only experience and continued attention to detail will makethis possible. Schapp et al.s dismal experience with an openposterior approach has demonstrated this all too well [25].

    If the laparoscopic hernioplasty works, which patientsshould be selected for the approach? Some insurance com-panies have suggested that the laparoscopic approach berestricted to young working patients with bilateral hernias orpatients with recurrent hernias [personal communication].Because hernias tend to be more complex in older patientsas well as those with a previous repair, these patients prob-ably benefit from a decreased incidence of recurrence to agreater degree than young patients with a primary hernia.Young, motivated patients, however, benefit most from ashortened recovery period and were able to quickly return towork without fear of tension or intrinsic weakness disrupt-ing their repair. Patients over 65 were able to return tonormal daily activities in less than a week, however, just asquickly as younger patients. All adult patients, young andold, laborers, office workers and retirees, appear to havebenefited from the laparoscopic approach; therefore, anyfuture studies comparing different hernia repairs should takeall of the groups into consideration.

    A recent editorial proposed that immediate cost and easeof repair should be viewed as the most important goals ofhernia repair in selected patients [22]. These goals are im-portant, but should be secondary to the incidence of recur-rence and morbidity of recovery associated with the repair.The true cost of any hernia repair to patients and society canbe reduced only by retaining these latter goals. Before weinclude or exclude any technique in our arsenal of weapons,we must understand the true benefits and risks of the pro-cedure in the hands of surgeons experienced in the tech-

    nique [1, 6, 11, 14, 19].

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    Report Indirect Direct Pantaloon Femoral FC

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    35. Wantz GE (1994) Properitoneal hernioplasty with unilateral giantprosthetic reinforcement of the visceral sac. Contemp Surg 44(2): 8389

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    Herniography and ultrasonography

    A prospective study comparing the effectiveness of laparoscopic hernia repair with

    extraperitoneal balloon dissection

    O. N. Dilek,1 M. Bozkurt,2 H. Arslan,2 E. Kisli,1 N. Poyraz,2 M. Berberoglu3

    Department of General Surgery, School of Medicine, Yuzuncu Yil University, Van, TurkeyDepartment of Radiology, School of Medicine, Yuzuncu Yil University, Van, TurkeyITEM, Advanced Medical Technologies Education Center

    Received: 29 March 1996/Accepted: 28 May 1996

    AbstractBackground: This study was designed to assess differencesbetween pre- and postoperative herniography and ultraso-nography in inguinal hernia performed laparoscopicallywith balloon dissection and mesh without suture.Methods: Pre- and postoperative herniographic and ultraso-nographic findings were analyzed in ten consecutive pa-ients. Postoperative ultrasonography was performed on the

    3rd and 7th days and herniography was performed on the7th day.Results: Following the operation both the herniography andultrasonography were almost normalized to a great extent innine patients. Overall, minimal impaired continence wasecorded by herniography in one patient. Also, we detected

    nonspecific soft-tissue thickening at the operation site inultrasonographic examination in four patients.Conclusions: As for inguinal hernias, compared with otheroperative modalities of treatment, laparoscopic hernia repairwith extraperitoneal balloon dissection and mesh without

    uture is a highly successful procedure and its minimal mor-

    bidity is well accepted by the patient.

    Key words: Herniography Inguinal hernia Laparo-copic herniorrhaphy Ultrasonography Mesh

    Hernia repair with laparoscopic procedure has been usedncreasingly in recent years and may be an alternative to

    conventional hernia repair methods. Today, various meth-

    ods used for hernia repair with laparoscopic procedures arestill being practiced. Total extraperitoneal (TEP)and trans-abdominal methods are the most preferred. They can beapplied in various ways to evaluate the effectiveness of anattempt made to patients with hernia. The diagnosis and thetreatment of hernias can be evaluated using pneumoperito-neum, computerized tomography, herniography, ultraso-nography (USG), losing of hernia sacs with physical exami-nation, and subjective complaints of the patients [2, 5, 6].We have not coincided with any study made radiologicallyfor evaluating in postoperative period of laparoscopic herniarepair in our Medline researching. In this study, the resultsof herniography and ultrasonography done in pre- and post-operative periods on ten patients who were operated on withthe TEP method were evaluated.

    Materials and methods

    In this prospective study, herniorrhaphy was applied to ten consecutivepatients, nine of whom were male and one female. Five right, three left, andtwo bilateral inguinal hernias were present in the patients. A balloon dis-sector was used extraperitoneally and 8 12 cm Prolene mesh was placedin the retroperitoneal region. Fixation of mesh was not done (Fig. 1).Herniography was performed preoperatively on the patients and on the 7thday in the postoperative period. USG was performed preoperatively andrepeated on the 3rd and 7th days in the postoperative period.

    Before the herniography was performed, patients defecated and uri-nated, which reduces the risk of perforation. The patient was laid in asupine position and the abdominal wall was cleaned. Via the left lowerquadrant, a needle penetrated the lateral border of the rectus muscle andentered the abdominal cavity. The needle was 10 cm long and 0.9 mm incaliber. Under fluoroscopic control 200 cc of contrast substance was in-

    jected. When the injection was completed, the patient was put in a proneposition. The patient was moved into different positions to collect contrastsubstance in peritoneal sacs. Then frontal and oblique views were takenwith the patient in a prone position and straining and with the tube angled20 caudally. Diagnostic criteria were the same as those reported previ-ously in herniographic series [2].

    Presented at the Annual Meeting of the Society of American Gastrointes-inal Endoscopic Surgeons (SAGES), Philadelphia, Pennsylvania, USA,

    March 1317, 1996Correspondence to: O. N. Dilek, Tip Fakultesi Hastanesi, Maras Cad. Van,Turkey

    Surg Endosc (1997) 11: 2931

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    additional hernia in our two cases, too. With the aim ofobserving the effectiveness of laparoscopic hernioplasty,herniography was used in the postoperative period, too, andx-rays were compared. Normal anatomic views were seenon the x-rays in the postoperative period. Technically andanatomically, laparoscopic hernioplasty is an attempt ofposterior wall. This situation showed that the operationechnique was well adjusted and effective for anatomic

    tructure.In our study, we established that the following up herniawith USG was more difficult (the related data was less). Butt gives more sensitive results in the diagnosis of localized

    fluid collection. The signs, other than these, remained un-certain and nonspecific.

    As a result, the etiology of pain of unknown cause canbe illuminated with preoperative herniography. Moreover,hernias that were undiagnosed previously can be establishedwith herniography, and it is clear that this will affect theform and success of the treatment. The operations effec-iveness can be established with herniography in the post-

    operative period. As a matter of fact, herniography is a safeand sensitive technique. Laparoscopic hernia repair that ismore effective, safer, more comfortable, and apparently isan alternative to conventional hernioplasty results.

    References

    1. Eames NWA, Deans GT, Lawson JT, Irwin ST (1994) Herniography foroccult hernia and groin pain. Br J Surg 81: 15291530

    2. Ekberg O (1981) Inguinal herniography in adults: technique, normalanatomy, and diagnostic criteria for hernias. Radiology 138: 3136

    3. Ekberg O, Abrahamsson P, Kesek P (1988) Inguinal hernia in urologicalpatients: the value of herniography. J Urol 139: 12531255

    4. Ekberg O, Lasson A, Kesek P, Van Westen D (1994) Ipsilateral mul-tiple groin hernias. Surgery 115: 557562

    5. Hergan K, Scheyer M, Oser W, Zimmerman G (1995) The normalultrasonic findings after a laparoscopic inguinal hernia operation. RofoFortschr Geb Rontgenstr Neuen Bildgeb Verfahr 162: 2932

    6. Timberlake GA, Ochsner MG, Powell RW (1989) Diagnostic pneumo-peritoneum in the pediatric patient with a unilateral inguinal hernia.Arch Surg 124: 721723

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    EndoScope: world literature reviews

    Original articles from a wide range of international surgical journals are selected by our editors and presentedhere as a structured summary and critical review. EndoScope serves as a quick and comprehensive surveyof the expansive endoscopic literature from all the corners of the globe.

    The value of minimal access surgery in the

    staging of patients with potentially resectable

    peripancreatic malignancy

    Conlon KC, Dougherty E, Klimstra DS, Coit DG,

    Turnbull AD, Brennan MFAnn Surg (1996) 223(2): 134140

    Objective: To explore the accuracy of laparoscopic stagingof patients with potentially resectable peripancreatic malig-nancy.Methods: Between December 1992 and August 1994, 115patients with radiologically resectable peripancreatic tumorswere prospectively enrolled in the study and underwent ex-ended laparoscopy before a planned curative resection.

    This technique of detailed laparoscopic staging included theassessment of the peritoneal cavity, liver, lesser sac, porta

    hepatis, duodenum, transverse mesocolon, and celiac andportal vessels.Results: Of the 115 patients, 108 patients underwent com-plete laparoscopic examination. Of the 67 patients consid-ered resectable, 61 resections were performed. Of the 115patients, 80 underwent open exploration with an overallesectability rate of 76%, as compared to the 35% resect-

    ability rate for the previous 1,135 patients who underwentaparotomy prior to December 1992. The positive predictivendex, negative predictive index, and accuracy of laparos-

    copy were 100%, 91%, and 94%, respectively. There wereno intraoperative or postoperative complications related to

    he laparoscopic procedure.Conclusions: Laparoscopy is an important component inhe staging of the patients with presumed resectable peri-

    pancreatic tumors. Staging laparoscopy may help reduce theate of unnecessary laparotomy in patients with unresectableumors.

    Comment: This study, although not randomized, and al-hough compared to a historical control group, brings us onetep closer to recognizing and accepting the role of stagingaparoscopy in the management of patients with presumedesectable peripancreatic tumors. Clearly, a prospective ran-

    domized study is needed before the final chapter on this

    controversy is written. In addition, two issues must bepointed out about this study: (1) The staging technique de-

    cribed requires advanced laparoscopic skills, and (2) thistudy does not address the financial issues important to this

    discussion.

    Thoracoscopic implantation of an epicardial

    pacemaker (case report)

    Robles R, Pinero A, Lujan JA, Parrilla PBr J Surg (1996) 86: 400

    Objective: To perform thoracoscopic implantation of epi-cardial pacemakers in patient with auriculoventricular block(AVB) in whom peripheral vein insertion of the electrocath-eter is not possible.Methods: A 55-year-old woman with chronic renal failureand a right arteriovenous fistual for hemodialysis and athrombosed innominate venous trunk required a pacemakerfor treatment of high-grade AVB. Following failure oftransvenous insertion of the electrocatheter, a thoracoscopicapproach for implantation of the epicardial electrode wasselected. Using a 10-mm trocar in the sixth intercostal space

    at the midaxillary line and two 5-mm trocars in the fourthand seventh intercostal spaces at the anterior axillary line, a4-cm pericardial window was created. The electrocatheterwas inserted and screwed into the muscular mass of themyocardium, proximal to the cardiac apex. The electrocath-eter was connected to the generator, which was implantedunder the fascia of the greater oblique. A pleural drain wasinserted and removed after 48 h. Following confirmation ofa functional pacing device, the patient was discharged home72 h after operation.Comment: The described technique appears to be a goodalternative to a subxiphoid approach or a thoracotomy for

    implantation of epicardial electrocatheters when the trans-venous approach is not possible. This technique may gainuniversal acceptance if the complication rate (in the handsof large number of surgeons and for a large number ofpatients) is kept at a minimum.

    Laparoscopic resection of solid liver tumours

    Gugenheim J, Mazza D, Kathouda N, Goubaux B,

    Mouiel JBr J Surg (1996) 83: 334335

    Objective: To describe the laparoscopic technique fornonanatomic liver resection.

    SurgicalEndoscopy

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    Methods: Three patients, ages 47, 44, and 33, had preop-erative diagnosis of liver lesions. The first patient had pre-vious diagnosis of breast cancer with a presumed liver me-astasis. Patients 2 and 3, who had been on oral contracep-ives for 15 and 16 years, respectively, were diagnosed with

    8-cm and 4-cm liver lesions, respectively. Preoperativeevaluation of these lesions could not rule out hepatocellularcarcinoma. All patients underwent laparoscopic, nonana-

    omic liver resection. Six laparoscopic ports were used ineach case. Ultrasonographic dissector and absorbable clipswere used to enhance the safety of the resection. Specimenswere removed using endoscopic retrieval bags, eitherhrough enlarged umbilical trocar sites or though a McBur-

    ney incision (patient 2 with an 8-cm lesion).Results: Histologic examination confirmed metastatic le-

    ion in patient 1 and focal nodular hyperplasia for patients2 and 3. No blood transfusion were necessary. Patients weredischarged in 57 days with no perioperative complications.The patient with metastatic lesion is alive after 17 monthswith no evidence of tumor recurrence.

    Comment: In the three cases presented, the laparoscopiciver resections performed are most likely identical to that

    performed had the patients undergone open liver resection.The laparoscopic approach is therefore justifiable. Whetheror not the laparoscopic approach can be applied to primaryiver neoplasms requiring anatomic liver resection is not

    addressed by this report. In addition, advantages of laparo-copic approach in this setting are anecdotal only.

    Laparoscopic common bile duct exploration:

    evolution of a new technique

    Khoo DE, Walsh CJ, Cox MR, Murphy CA, Motson RWBr J Surg (1996) 83: 341346

    Objective: To report and discuss the authors experiencewith variety of techniques used for exploration of the commonbile duct (CBD) at the time of laparoscopic cholecystectomy.Methods: Sixty patients among 638 who underwent lapa-oscopic cholecystectomy (LC) required CBD exploration

    as indicted by intraoperative cholangiography or preopera-

    ive endoscopic retrograde cholangiopancreatographyERCP). Laparoscopic CBD exploration was performed us-ng a fiberoptic choledochoscope, either through the cystic

    duct incision used for cholangiography or through a newncision onto the CBD itself. Stone baskets and balloons

    were used to retrieve the stones out of the cystic duct orpush the stones into the duodenum. CBD incisions wereeither primarily closed and drained, or closed over a T-tube.n cases of inadequate or unsuccessful clearance of CBD,reatment options included drainage via a cystic duct cath-

    eter and subsequent postoperative percutaneous clearance ofCBD, open CBD exploration, or postoperative ERCP.

    Results: The median time for LC with CBD explorationwas 150 min (90300) compared to 80 min (55180) for LCalone. The overall success of duct clearance without ERCPor open common bile duct exploration (including those thatwere cleared postoperatively through the T-tube or the cys-ic duct tract) was 86% (44 out of 51). Six patients required

    postoperative ERCP for clearance of residual stones. One ofthese patients died of unrelated causes prior to actual per-formance of the ERCP. The eight reported complicationsare as follows: One patient with a cystic duct tube had bileleak, undergoing successful percutaneous drainage; one pa-tient had prolonged drainage from a subhepatic drain; threepatients had right hypochondrial pain or pyrexia, requiringprolonged hospital stay; one patient had retained CBD

    stones presented with cholangitis while awaiting ERCP; onepatient had pulmonary infection with prolonged hospitaliza-tion; and one patient had urinary retention.Comment: This original article presents an excellent dis-cussion of techniques of CBD exploration and alternativesto this approach. Clearly, there is no consensus in preop-erative, operative, and postoperative management of cho-ledocholithiasis. However, as suggested by this report, withimproved expertise in laparoscopic CBD exploration, treat-ment of CBD stones may once again swing from routinepre- or postoperative ERCP back to operative CBD explo-ration as in the prelaparoscopic era.

    Technique for full-thickness muscle closure of

    laparoscopic port sites

    Robertson GSM, Lloyd DM, Kelly MJ, Veitch PSBr J Surg (1996) 83: 383

    Objective: To report a technique for full-thickness closureof all laparoscopic trocar site muscle and fascia defects 10

    mm or greater in diameter.Methods: Using a combination of a dismantled Veressneedle and a straight needle on a suture, a simple techniquefor full-thickness closure of laparoscopic trocar sites is de-scribed. In the presence of at least one 5-mm port, all 10-mm-or-larger-diameter trocar sites can be closed expedi-tiously using the described technique.Comment: Until a universally accepted technique for clo-sure of the muscle and fascia defects at the site of a lapa-roscopic cannulae is identified, all proposed techniques forsuch closure should be welcomed and attempted. Withoutpersonal experience with the described technique, laparos-

    copists are encouraged to follow this well-illustrated tech-nique (illustrations are found with the original report) anddevelop their own opinion of this technique.

    Early versus delayed laparoscopic

    cholecystectomy for treatment of

    acute cholecystitis

    Lo CM, Liu CL, Lai ECS, Fan ST, Wong J

    Ann Surg (1996) 223(1):3742

    Objective: To examine the outcome of early (within 120 h)laparoscopic cholecystectomy following a diagnosis ofacute cholecystectomy, as compared to that for delayed cho-lecystectomy.

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    Methods: A retrospective review of 52 patients with a di-agnosis of acute cholecystitis who ultimately underwentcholecystectomy is presented. Twenty-seven underwentearly cholecystectomy and 25 had interval cholecystectomy,all initially attempted laparoscopically. The following vari-ables were noted to be similar within the two groups: age,

    ex, body weighty, previous biliary symptoms, previous ab-dominal surgery, duration of acute symptoms, fever, WBC

    count, total serum bilirubin, alkaline phosphatase, and ureameasurements.Results: There were no major operative complications andno mortality in either group. The conversion rate (7.4%) andminor complication rate (22%) were comparable in the twogroups. The early group required modifications in operativeechnique (gallbladder decompression, close suction drain-

    age, use of endoscopic pouches for retrieval of the speci-men, and use of additional cannulae) more frequently thanhe delayed group. Although the operative time (137.2 vs

    98.0 min) and postoperative hospital stay (4.6 vs 2.5 days)were higher for the early operative group, the total hospital

    tay was markedly reduced (6.7 vs 15.1 days).Conclusions: Early laparoscopic cholecystectomy follow-ng acute cholecystitis does not increase the risk of compli-

    cations or conversion to laparotomy. Although the operations technically more demanding in the early period following

    acute cholecystitis, it provides the economical advantagesof reduced hospital stay as compared to that for delayedcholecystectomy.Comment: This retrospective review of a small sample sizellustrates the economic advantages of early cholecystecto-

    my for acute cholecystitis. It, however, fails to point out theclinical advantages, to the patient, following early removal

    of a diseased and nonfunctioning or stone-harboring gall-bladder. It is also important to note that for elderly or de-bilitated patients, prolonged operative time is less desirableand, therefore, early cholecystectomy in this select popula-ion may be less advisable.

    Mechanisms of gastric and esophageal

    perforations during laparoscopic

    Nissen fundoplication

    Schauer PR, Meyers WC, Eubanks S, Norem RF,Franklin M, Pappas TNAnn Surg (1996) 223(1):3742

    Objective: To determine the mechanisms for gastric andesophageal injuries during laparoscopic Nissen fundoplica-ion (LNF).

    Methods: A review of 17 gastric and esophageal perfora-ions following LNF is presented. For each perforation, de-ails including the mechanism of injury, surgeons experi-

    ence, diagnosis, treatment, and the ultimate outcome of the

    njury are reviewed.Results: The majority of injuries occurred within the first10 LNFs performed by each individual surgeon. Threemechanisms accounted for all of the 17 injuries: improperetroesophageal dissection (10), passage of the esophageal

    dilator or nasogastric tube (five), and suture pullthrough

    (two). When diagnosed at surgery, repair of perforation wasmostly accomplished by primary closure and wrap to in-clude the repair. Five perforations were repaired followingconversion to laparotomy, and another required thoracoto-my for repair of a thoracic esophageal perforation. Delayeddiagnosis of perforation in six patients adversely affectedtheir outcome (including one death in the entire series).Conclusions: Gastric and esophageal perforation during

    LNF are serious complications with significant associatedmorbidity and mortality. A full understanding of the de-tailed anatomy of the gastroesophageal region and aware-ness of the mechanisms of perforation may help reduce theincidence of these complications.Comments: The increase in morbidity and mortality asso-ciated with the delayed diagnosis of gastric or esophagealperforations may justify the use of routine contrast esophago-gastrography following laparoscopic Nissen fundoplication.

    Diaphragmatic herniation afterpenetrating trauma

    Degiannis E, Levy RD, Sofianos C, Potokar T,Florizoone MGC, Saadia RBr J Surg (1996) 83:8891

    Objective: To review one trauma centers experience withtraumatic diaphragmatic hernias and the risk factors asso-ciated with mortality in this patient population.Methods: A retrospective review of the outcome of 45 dia-

    phragmatic herniations during a 7-year period (between1987 and 1994) is presented.Results: All herniations were through the left hemidia-phragm. In 29, the diagnosis was made early (during theinitial hospitalization), and in 16 during a subsequent ad-mission (delayed presentation). Within these two groups,the mortality rates were 3% and 25%, respectively. Thepresence of gangrenous or perforated abdominal viscera inthe thoracic cavity was the single most common and com-plicating factor among the fatalities.Conclusions: The early diagnosis of traumatic diaphrag-matic injuries is paramount to the salvage of otherwise sur-

    vivable patients with penetrating thoracoabdominal injuries.Comment: With trauma surgeons evergrowing facility inlaparoscopic surgery, diagnostic laparoscopy may becomethe gold standard in the management of patients with pen-etrating thoracoabdominal injuries who have no other indi-cations for immediate laparotomy.

    Factors affecting conversion of laparoscopic

    cholecystectomy to open surgery

    Liu CL, Fan ST, Lai ECS, Lo CM, Chu KMArch Surg (1996) 131:98101

    Objective: To identify risk factors predictive of conversionof a laparoscopic cholecystectomy to a laparotomy.

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    Methods: A retrospective review of 500 patients operatedon between 1991 and 1994 is presented. Demographic, ul-rasonographic, and operative data are examined.

    Results: The following factors significantly increased theneed for conversion to laparotomy: age over 65, obesity,acute cholecystitis followed by interval elective cholecys-ectomy, ultrasonographic finding of thickened gallbladder

    wall, procedures performed during the learning curve (for

    his series), and surgery performed by senior surgeons (inhis group of five surgeons). Sex, previous lower abdominalurgery, history of acute pancreatitis or cholangitis, im-

    paired liver function on presentation, or emergency laparo-copic cholecystectomy for acute cholecystitis did not sig-

    nificantly increase the rate of conversion to laparotomy.Conclusions: Knowledge of factors contributing to the in-cidence of conversion to laparotomy during laparoscopiccholecystectomy may help to better prepare the patient, theoperating room schedule, and the duration of convales-cence.Comment: The conclusions from this retrospective study

    are most appropriate. In 1996, almost every cholecystecto-my candidate deserves a laparoscopic attempt. However, theknowledge of risk factors for conversion to laparotomy al-ow for a more thorough discussion between the surgeon

    and the patient and better mental preparation for not onlyhe patient, but the operating room staff.

    Surgical resection for small

    hepatocellular carcinoma

    Nagashima I, Hamada C, Naruse K, Osada T, NagaoT, Kawano N, Muto TSurgery (1996) 119:4045

    Objective: To investigate the clinicopathologic determi-nants of the long-term prognosis for surgically resected soli-ary small hepatocellular carcinoma (s-sHCC; 2 cm or lessn diameter).

    Methods: A retrospective review of 44 survivors of partialhepatectomy for s-sHCC between 1977 and 1992 is re-ported. There were six others who died perioperatively. Theeight clinicopathologic features examined are as follows:presence of vascular invasion, capsular formation, the dis-ance of free surgical margin, serum alpha-fetoprotein level,

    positive hepatitis B surface antigen, preoperative transarte-ial embolization, Childs classification, and complicatediver function.

    Results: Complicated liver function (a scoring systemwhich is based on serum albumin, indocyanine green reten-ion, prothrombin time, platelet count, and preoperative

    presence or absence of ascites) wa