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Original article Outcome of antegrade continence enema procedures for faecal incontinence in adults J. H. Lef ` evre, Y. Parc, G. Giraudo, S. Bell, R. Parc and E. Tiret Department of Digestive Surgery, H ˆ opital Saint-Antoine Assistance Publique-H ˆ opitaux de Paris (AP-HP), University Pierre et Marie Curie Paris VI, 184 Rue du Faubourg Saint-Antoine, F-75571 Paris, France Correspondence to: Professor Y. Parc (e-mail: [email protected]) Background: Faecal incontinence has major consequences. Colostomy has been the mainstay of therapy when other options fail. Operations such as the Malone procedure have been proposed as an alternative. The aim of this study was to evaluate the outcomes and quality of life of patients having a Malone procedure for the treatment of faecal incontinence. Methods: Charts of patients who had had a Malone procedure or equivalent between 1998 and 2004 were reviewed. The patients completed a Short Form (SF) 36 quality of life questionnaire. Results: The study included 25 patients (17 female; median age 47 years). In seven, the appendix was used; an ileoneoappendicostomy was performed in the other 18. Three patients were lost to follow-up; the remaining 22 were followed for a median (range) of 21 (1–61) months. Five patients had a cutaneous stenosis; another had the appendicostomy removed and replaced by a colostomy. Four patients no longer used the stoma for irrigation. All other patients were completely clean except one, who reported occasional night-time seepage. The mean SF-36 showed a good physical recovery (43·9) but persisting psychological distress (36·0). Conclusion: The Malone procedure or equivalent achieves good results in the management of faecal incontinence, although psychological distress persists after surgery. Presented to the Tripartite Colorectal Meeting, Dublin, Ireland, July 2005, and published in abstract form in Colorectal Disease 2005; 7(Suppl 1): 088 Paper accepted 27 July 2006 Published online 4 September 2006 in Wiley InterScience (www.bjs.co.uk). DOI: 10.1002/bjs.5383 Introduction The prevalence of faecal incontinence in the general pop- ulation is about 2 per cent 1 . However, this increases with age, reaching 11 per cent in men and 26 per cent in women older than 50 years 2 . Incapacity to control stool is a major handicap for occupational, social, sporting, emotional and sexual life, with a significant negative impact on social confidence and wellbeing. Many treatments have been described, both conservative and surgical 3 . Conservative treatments include antidiarrhoeal medication and biofeed- back; surgical procedures include sphincter repair, sacral nerve stimulation, muscle transposition (dynamic gracilo- plasty) and artificial sphincter implantation. Some patients, however, end up with a terminal colostomy after failure of these measures 4 . Since the description of a transappendicular continent cystostomy for the treatment of urinary incontinence by Mitrofanoff in 1980 5 , the principle of a continent catheterizable intestinal tube has been reported for the treatment of faecal incontinence and constipation 6 . Initially described in children 7,8 , colonic antegrade enema has been developed to complete colonic emptying to achieve faecal continence in adults 9 . Alternative operations have been developed for patients who have had an appendicectomy or an atrophic appendix: a conduit fashioned with a tubularized caecum 10 or the ileum 11,12 . The aim of this study was to evaluate these procedures for the treatment of faecal incontinence in adults with a specific focus on quality of life results. Patients and methods Between 1998 and 2004, 25 patients (17 female and eight male) had a Malone or ileoneoappendicostomy (INA) Copyright 2006 British Journal of Surgery Society Ltd British Journal of Surgery 2006; 93: 1265–1269 Published by John Wiley & Sons Ltd

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Original article

Outcome of antegrade continence enema procedures for faecalincontinence in adults

J. H. Lefevre, Y. Parc, G. Giraudo, S. Bell, R. Parc and E. TiretDepartment of Digestive Surgery, Hopital Saint-Antoine Assistance Publique-Hopitaux de Paris (AP-HP), University Pierre et Marie Curie Paris VI,184 Rue du Faubourg Saint-Antoine, F-75571 Paris, FranceCorrespondence to: Professor Y. Parc (e-mail: [email protected])

Background: Faecal incontinence has major consequences. Colostomy has been the mainstay of therapywhen other options fail. Operations such as the Malone procedure have been proposed as an alternative.The aim of this study was to evaluate the outcomes and quality of life of patients having a Maloneprocedure for the treatment of faecal incontinence.Methods: Charts of patients who had had a Malone procedure or equivalent between 1998 and 2004were reviewed. The patients completed a Short Form (SF) 36 quality of life questionnaire.Results: The study included 25 patients (17 female; median age 47 years). In seven, the appendix wasused; an ileoneoappendicostomy was performed in the other 18. Three patients were lost to follow-up;the remaining 22 were followed for a median (range) of 21 (1–61) months. Five patients had a cutaneousstenosis; another had the appendicostomy removed and replaced by a colostomy. Four patients nolonger used the stoma for irrigation. All other patients were completely clean except one, who reportedoccasional night-time seepage. The mean SF-36 showed a good physical recovery (43·9) but persistingpsychological distress (36·0).Conclusion: The Malone procedure or equivalent achieves good results in the management of faecalincontinence, although psychological distress persists after surgery.

Presented to the Tripartite Colorectal Meeting, Dublin, Ireland, July 2005, and published in abstract form in ColorectalDisease 2005; 7(Suppl 1): 088

Paper accepted 27 July 2006Published online 4 September 2006 in Wiley InterScience (www.bjs.co.uk). DOI: 10.1002/bjs.5383

Introduction

The prevalence of faecal incontinence in the general pop-ulation is about 2 per cent1. However, this increases withage, reaching 11 per cent in men and 26 per cent in womenolder than 50 years2. Incapacity to control stool is a majorhandicap for occupational, social, sporting, emotional andsexual life, with a significant negative impact on socialconfidence and wellbeing. Many treatments have beendescribed, both conservative and surgical3. Conservativetreatments include antidiarrhoeal medication and biofeed-back; surgical procedures include sphincter repair, sacralnerve stimulation, muscle transposition (dynamic gracilo-plasty) and artificial sphincter implantation. Some patients,however, end up with a terminal colostomy after failure ofthese measures4.

Since the description of a transappendicular continentcystostomy for the treatment of urinary incontinence

by Mitrofanoff in 19805, the principle of a continentcatheterizable intestinal tube has been reported for thetreatment of faecal incontinence and constipation6. Initiallydescribed in children7,8, colonic antegrade enema has beendeveloped to complete colonic emptying to achieve faecalcontinence in adults9. Alternative operations have beendeveloped for patients who have had an appendicectomyor an atrophic appendix: a conduit fashioned with atubularized caecum10 or the ileum11,12. The aim of thisstudy was to evaluate these procedures for the treatmentof faecal incontinence in adults with a specific focus onquality of life results.

Patients and methods

Between 1998 and 2004, 25 patients (17 female and eightmale) had a Malone or ileoneoappendicostomy (INA)

Copyright 2006 British Journal of Surgery Society Ltd British Journal of Surgery 2006; 93: 1265–1269Published by John Wiley & Sons Ltd

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1266 J. H. Lefevre, Y. Parc, G. Giraudo, S. Bell, R. Parc and E. Tiret

Table 1 Aetiology of faecal incontinence in 25 patients

Aetiology No. of patients

Anorectal malformation 7 (28)Spinal cord injury 7 (28)Other pelvic floor operations 4 (16)Spina bifida 2 (8)Obstetric injury 2 (8)Meningitis 2 (8)Currarino syndrome 1 (4)

Values in parentheses are percentages.

procedure in the authors’ institution. The mean(s.d.) ageat the time of surgery was 45(19·3); median (range) 47(16–76) years.

Aetiologies of faecal incontinence are listed in Table 1.Nine patients had previously had an operation to treatfaecal incontinence: sphincter repair (five), sacral nervestimulation (two) and dynamic graciloplasty (two). Themean(s.d.) delay between diagnosis of faecal incontinenceand the Malone procedure being done was 18·5(13·6)years; median (range) 20 (2–47) years. All patients had anincompetent anal sphincter; none had a spastic anus.

Surgical techniques

All patients received prophylactic antibiotics and had amidline incision. Initially, patients with an appendix stillin place had the Malone technique, where the base ofthe appendix was intussuscepted with interrupted non-resorbable stitches to produce a pseudocontinent valve.The tip of the appendix was delivered through a right iliacfossa incision, and a small stoma was created. The caecumwas sutured to the abdominal wall in order to create astraight conduit from the skin to the caecum.

In the remaining patients, a neoappendix was fashionedfrom the ileum creating an INA inspired by the techniquereported by Christensen et al.12. The abdominal wallthickness was measured and the ileum divided at anequivalent distance from the ileocaecal valve. A 14-Frsilicone tube was inserted in the caecum through the ileumto calibrate the neoappendix. Then, with a 50-mm GIA

TM

stapling device (Tyco, Norwalk, Connecticut, USA) theileum was divided longitudinally. The base of the ileocaecalvalve was intussuscepted with interrupted non-resorbablestitches. The caecum was also sutured to the abdominalwall. An end-to-side anastomosis was then handsewn torestore intestinal continuity.

A 14-Fr catheter was inserted into the stoma and left inplace for 3 weeks. Two weeks after surgery, daily enemaswere started using 500–1000 ml of tap water.

Results and quality of life

Each patient underwent a structured telephone interviewto describe bowel emptying procedures and evaluate theirsatisfaction. To minimize observer bias, the interviewerwas not one of the operating surgeons. The result wascategorized as excellent, good, unchanged or poor. Health-related quality of life was assessed with the MedicalOutcomes Study 36-Item Short Form Health Survey(SF-36)13,14, which was mailed to each participant. Ifno response was received within 1 month, a reminderwas sent. After 2 months without completion, participantswere contacted by telephone. The SF-36 measures eightdomains of quality of life: physical functioning, rolephysical, role emotional, bodily pain, vitality, mentalhealth, social functioning and general health. All scores arestandardized so that the worst possible score is 0 and thebest possible score is 100. Each domain is scored separatelyand is not additive. The physical and mental componentsummary scales (PCS and MCS respectively) are computedas weighted composites of the eight subscales. PCSand MCS scores were then compared with publishednormative data from the general population (PCS mean:50, 95 per cent confidence interval (c.i.) 44·3 to 55·7; MCSmean: 50, 95 per cent c.i. 43·7 to 56·3). If the score wasoutside the c.i., the difference was considered statisticallysignificant15.

Statistical analysis

Results are presented as mean(s.d.); Student’s t test and χ2

test were used as appropriate. A P value of less than 0·050was considered significant. Statview Software 1992–1998was used for analysis (SAS Institute, Cary, North Carolina,USA).

Results

Surgical procedures

Seven patients had a Malone operation and 18 an INA.The mean(s.d.) hospital stay was 10·4(1·1) days; median(range) 9 (3–22) days. There was no difference betweenthe two techniques (11·6 days versus 10·0 days; P = 0·516).

Morbidity

Five patients developed a stenosis of the stoma, three afteran appendicostomy and two after an INA (three of sevenversus two of 18; P = 0·070). However, this difference wasnot significant. All patients initially had a dilatation, but tworequired surgery: one had an enlargement of a cutaneous

Copyright 2006 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2006; 93: 1265–1269Published by John Wiley & Sons Ltd

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Enema procedures for faecal incontinence 1267

ring sclerosis and the other had his appendicostomyresected and an INA performed.

Long-term results

Twenty-two patients were available for follow-up. Onedied from a cause unrelated to incontinence or its treatmentand two were lost to follow-up. Eighteen patients were stillusing their stoma at a mean(s.d.) follow-up of 32·4(16·6)months; median (range) 26 (10–85) months. Of the fourpatients who had stopped using the stoma, one underwenta colostomy 2 years after the INA for persisting faecalincontinence, one stopped using his INA because ofabdominal pain during enemas, and two other patients hadleakage of intestinal contents from the stoma after a Maloneprocedure. The remaining 18 patients were continent forfaeces and flatus; however, one patient reported occasionalanal soiling without the need to wear a pad. Fourteenpatients used a little gauze to cover their stoma and fourleft it uncovered. No patient needed medical treatmentsuch as constipating treatment or analgesia.

Among the patients using their stoma, two used it everyday, 10 every 2 days, five every 3 days, and one every7 days. There was no statistical difference between the twotechniques (3·2 days after Malone and 2·2 days after INA,P = 0·157).

The mean(s.d.) time to perform washouts was 39·7(11·0);median (range) 40 (30–60) min. The mean time was44·0 and 38·1 min after Malone and INA respectively(P = 0·320). Only one patient added phosphate enema totap water. The mean(s.d.) volume of tap water used was1·5(0·5) litres; median (range) 1·5 (0·5–2·5) litres. Onlyone patient needed help to perform the enemas. Noneof the patients needed to take a bath or shower after theenema to be clean.

Among the patients using their stoma, 16 judged theirresult excellent, two good and one unchanged. For the fourpatients not using their stoma, satisfaction was consideredpoor.

Quality of life (Short Form 36 form)

Eighteen patients using their stoma returned the SF-36form. Table 2 gives the mean norm-based scale scores foreach of the eight subscales of the SF-36. The mean physicalscore is 43·9 (95 per cent c.i. 44·3 to 55·7) and the meanmental score is 36·0 (95 per cent c.i. 43·7 to 56·3) in thenormal population. Table 3 gives the SF-36 results for eachprocedure. Statistical differences were noted for four itemswhen the two procedures were compared. Patients with theMalone procedure had less pain, a better social functioning

Table 2 Norm-based scores of the Short Form 36 questionnaireafter surgery (0: worst; 100: best)

Subscale Median s.d. Range

Physical functioning 45·4 15·1 20–90Role physical 42·0 16·8 0–75Pain 43·7 14·6 12–62·7General health 40·3 13·4 10–60·3Vitality 40·3 13·8 5–60·9Social functioning 37·8 14·3 0–57·1Role emotional 33·4 16·8 0–55·3Mental health 36·1 16·5 0–61·8Physical component summary scales 43·9 10·3 25·7–59·6Mental component summary scales 36·0 13·0 11·1–58·3

Table 3 Norm-based scores of the two surgical procedures (0:worst; 100: best)

CharacteristicsMalone(n = 5)

Ileoneoappendicostomy(n = 13) P*

Physical functioning 50·3 45·5 0·530Role physical 53·4 40·8 0·083Bodily pain 56·2 41·3 0·022General health 49·3 38·0 0·108Vitality 50·0 38·95 0·080Social functioning 48·4 36·5 0·041Role emotional 51·1 29·2 0·003Mental health 52·2 30·8 0·009

Physical global scale 50·5 42·7 0·121Mental global scale 50·4 31·5 0·002

*Student’s t-test.

score, a better role emotional score and a better mentalscore. The global mental score was superior in the Malonegroup (50·4 versus 31·5; P = 0·002).

Discussion

Faecal incontinence remains a therapeutic problem in manypatients when conservative measures (medical treatmentor biofeedback) fail and sphincter repair is unsuccessful orinappropriate. Biological or artificial neosphincters offertherapeutic options in these cases, but have a significantfailure rate and high associated morbidity16,17. Sacralnerve stimulation is also an alternative approach, withan approximate success rate of 80 per cent in patientswho have a neurologically intact sacral plexus and ananatomically intact anal sphincter and rectum18–20. Despitethe clinical benefit of these techniques, some patientsrequire a terminal colostomy. In 1990, Malone et al.6

reported the use of antegrade colonic irrigation viathe appendix in five children with incontinence andsubsequent reports showed it to be effective in more than

Copyright 2006 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2006; 93: 1265–1269Published by John Wiley & Sons Ltd

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1268 J. H. Lefevre, Y. Parc, G. Giraudo, S. Bell, R. Parc and E. Tiret

90 per cent of patients7,8. Since then, antegrade colonicwashouts have become an important addition to thetreatment of faecal incontinence in children and adults21,22.Such good results led some authors to propose theMalone procedure in association with perineal colostomyafter abdominoperineal resection to provide acceptablecontinence and to avoid iliac colostomy23.

In this series, early results can be compared favourablywith previous reports9,24, with no early surgical complica-tions. In the medium term, stenosis at the mucocutaneousjunction occurred in five of 25 patients and is in accordancewith several previous studies7,25,26. Stenosis occurred morefrequently in patients with appendicostomy (three of sevenversus two of 18), but this difference was not significant.Larger series may confirm these differences in the compli-cation rate of both techniques.

After a median follow-up of 21 months in this series, 18of the 22 patients were still performing antegrade colonicenemas. Such results are comparable to those reportedin children25 and adult patients24,27. Among the fourpatients that had stopped performing antegrade enemas,one did so for persistent major incontinence, one becauseof abdominal pain during the enemas and two because ofleakage of intestinal contents from the stoma. Only thosewho had persistent incontinence had a terminal colostomyafter an ileocaecal resection. These four patients judgedtheir result to be poor. Among the 18 other patients,one reported occasional anal soiling and judged his resultas unchanged. All the 17 remaining patients had perfectcleanliness and considered their result as excellent or good.Such a high satisfaction rate has been previously reportedin children24 and adults27.

In this study, a general quality of life form was usedinstead of a score focused on incontinence, as almost allpatients were clean. The use of an incontinence scorewould not have reflected the consequences of the Maloneor INA procedure on patient quality of life, especiallythe drawbacks represented by the manoeuvres required touse it.

The benefit reported by the patients of this series reflectsthe ease of performing antegrade enemas to maintaincleanliness. Only one patient required help to performthe enemas. The mean time required was 40 min andalmost all patients (15) performed an enema every 2 or 3days. Combining this result with the physical global scaleof the 36-Item Short-Form Health Survey health statusquestionnaire, it appears that physical quality of life isalmost normal after the Malone operation or equivalent,which is in accordance with several previous studies7,26,28.

In this series the global mental scale remained signif-icantly inferior to the general population. Psychological

troubles related to the long-term pathology responsiblefor the faecal incontinence may explain the persistenceof psychological distress. Comparison of the two surgicaltechniques showed that the global mental scale was sig-nificantly higher after Malone than INA (50·4 versus 31·5,P = 0·002). These findings have to be balanced with thebenefit of INA already described. The authors have chosento perform INA because of reports of leakage of intesti-nal content29,30 and their own experience with stenosisof the appendicostomy. The low rate of reflux after INAsupports that decision. Some authors recommend the Mal-one technique in children when the appendix is available,since this is an easier technique31 and complications areless common30. Nevertheless, the difference in terms ofpsychological distress between patients treated with Mal-one and patients treated with INA had led the authorsto continue to prefer INA. However, a randomized trialis required to answer definitively the question of whichprocedure to use when both are possible.

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Copyright 2006 British Journal of Surgery Society Ltd www.bjs.co.uk British Journal of Surgery 2006; 93: 1265–1269Published by John Wiley & Sons Ltd