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Secondary implantation of an artificial sphincter after abdominoperineal resection and pseudocontinent perineal colostomy for rectal cancer
© Masson, Paris, 2005.
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Gastroenterol Clin Biol 2005;29:425-428
Secondary implantation of an artificial sphincter after abdominoperineal resection and pseudocontinent perineal colostomy for rectal cancer
Frédéric MARCHAL (1), Carole DOUCET (1), David LECHAUX (2), Philippe LASSER (3), Paul-Antoine LEHUR (1) (1) Clinique chirurgicale II, Pôle digestif, Hôtel Dieu, Place Alexis Ricordeau, 44093 Nantes ; (2) Service de chirurgie digestive, Centre hospitalier, 22000 St Brieuc ; (3) Département de Chirurgie, Institut Gustave Roussy, 39, rue Camille Dumoulin, 94805 Villejuif.
SUMMARY
RÉSUMÉ
Introduction — Fecal continence with a perineal colostomy performed after abdominoperineal resection (APR) is not always satisfactory despite retrograde colonic enemas. Functional improvement is currently examined using artificial sphincters. Preliminary results are disclosed.
Implantation secondaire d’un sphincter artificiel après amputation abdomino-périnéale et colostomie périnéale pseudocontinente pour cancer du rectum Frédéric MARCHAL, Carole DOUCET, David LECHAUX, Philippe LASSER, Paul-Antoine LEHUR (Gastroenterol Clin Biol 2005;29:425-428)
Patients — In 3 female patients, 45, 59 and 68 years old, curative APR and perineal colostomy were performed after radiotherapy in 2, for T1-2N0 cancer of the lower rectum. Due to occasional leaks, need for strict diet and fear of incontinence, an Acticon Neosphincter® (AMS) was implanted consecutively at a mean 4.5 years after APR.
Introduction — En cas de colostomie périnéale réalisée après amputation abdomino-périnéale (AAP), la continence fécale n’est pas toujours satisfaisante. Nous rapportons ici l’implantation de sphincter artificiel pour en améliorer le résultat fonctionnel. Malades — Trois malades, âgées de 45, 59 et 68 ans, avaient été traitées par AAP et colostomie périnéale pour cancer du bas rectum T1-2N0, avec radiothérapie préopératoire dans 2 cas. En raison de mauvais résultats fonctionnels, un sphincter artificiel Acticon Neosphincter (AMS) a été implanté de façon consécutive, en moyenne 4,5 ans après AAP.
Results — Device implantation was feasible and uneventful. In one case, a superficial hematoma was drained and healed by second intention. Devices were activated 3 months after implantation. At a mean 2.5 years follow-up, the 3 patients had an activated and functional artificial sphincter. Leaks and fecal urgency significantly decreased but colonic enemas were maintained. Dietary restrictions were less and quality of life improved. All 3 considered the device as a useful adjunct.
Résultats — L’implantation du matériel n’a pas posé de difficultés. Un hématome sous-cutané a été drainé. Les sphincters ont été activés à 3 mois de l’implantation. A 2,5 ans de suivi médian, les 3 malades avaient un sphincter artificiel activé et fonctionnel. Les fuites et les urgences défécatoires ont été diminuées, mais les irrigations ont été maintenues. Le régime alimentaire n’était plus nécessaire. La qualité de vie était améliorée. Les 3 malades considéraient le sphincter artificiel comme un progrès.
Conclusion — In this limited experience, implantation of artificial sphincter around a perineal colostomy following APR for rectal cancer appeared feasible and safe even in case of previous radiotherapy. Mid-term tolerance was satisfactory. Continence and quality of life significantly improved.
Conclusion — Dans cette série préliminaire, l’implantation d’un sphincter artificiel autour d’une colostomie périnéale après AAP pour cancer du rectum apparaît réalisable et sûre, même en cas de radiothérapie préopératoire. La tolérance à moyen terme est satisfaisante. La continence fécale et la qualité de vie sont significativement améliorées.
P
nence in case of perineal colostomy [4]. However, this technique is associated with a high rate of complications that impairs functional results [4]. The most recent option designed to recreate a sphincteric mechanism after APR and perineal colostomy, consists of the implantation (in the same procedure or as a second step) of an artificial sphincter around the perineal stoma [5]. We reported herein our initial experience of artificial sphincter implanted in patients with unsatisfactory functional results following pseudocontinent perineal colostomy performed after APR.
atients with cancer of lower rectum, with or without involvement of the anal canal, still need to be treated with abdominoperineal resection (APR). Abdominal colostomy represents a definitive condition that alters body image. Such an alteration, however, is unacceptable to some patients, which had led to the development of innovative reconstruction processes. Intersphincteric resection with colonic reservoir and coloanal anastomosis has been shown to give good local control and with acceptable functional results, in selected patients having lesions 2 cm from the anal verge [1, 2]. Creation of a pseudocontinent perineal colostomy is also a means to avoid an abdominal stoma. It can be constructed with or without an auto-transplant of a free flap of colonic muscle around the colon, a few centimeters upstream of the perineal stoma [3]. The use of single or double dynamic (electrostimulated) gracilis muscle is an another method in obtaining a neosphincter and improve conti-
Patients and methods In 2001 and 2002, three consecutive female patients (age 46, 59 and 68 years) had an artificial sphincter (Acticon Neosphincter®, American Medical Systems, Minneapolis, MN, USA) implantation around a Presented as a poster at the 3rd meeting of the European Association of Coloproctology (Erlanguen, Germany- September 13-15, 2002). Supported by a grant from the CEREC (Centre d’Études et de Recherche en Chirurgie) — Nantes.
Reprints : P.-A. LEHUR, Clinique chirurgicale II, Pôle digestif, Hotel Dieu, Place Alexis Ricordeau, 44093 Nantes. E-mail : [email protected]
425
F. Marchal et al.
perineal colostomy. We have previously used the artificial sphincter device to treat patients with fecal incontinence. The 3 patients had curative APR and pseudocontinent perineal colostomy, following radiotherapy in 2, for T1-2, N0 rectal cancer, at respectively 35, 79 and 44 months before artificial sphincter implantation. Despite regular enemas, these 3 patients complained of occasional leaks, a need for a strict diet and restriction in social activities, psychological disturbances related to fear of incontinence and impaired quality of life. To improve their functional status, they accepted the implantation of an artificial sphincter with the knowledge that its use was experimental. Our standard regimen for implantation included preoperative cutaneous and bowel preparation during a 48-hour period before surgery with retrograde enemas, repeated cleansing with an iodinized disinfectant and vaginal irrigation. Antibiotic prophylaxis (aminoside and third generation cephalosporins) was given at induction. Before the onset of surgery, adequacy of the bowel preparation was assessed. The patient was placed in a modified lithotomy position. The occlusive cuff surrounding the colon was placed using one transverse anterior incision. The anterior tunnel was created under direct vision; the posterior tunnel was formed by blunt dissection. The best site of cuff implantation was at distance of 4 cm or more from the skin incision. After completion of the tunnels, a cuff sizer was pulled around the colon to measure the appropriate length and width of the cuff. The reservoir balloon was placed in the prevesical space via a lower transversal abdominal incision and inflated with the appropriate amount of radiopaque fluid. From this incision, the pump was inserted in the upper part of the homolateral labia (left if the patient was right-handed, and vice versa). At completion of the operation, the device was left deactivated for 3 months postoperatively. No stoma was performed. A bladder catheter was placed for a 3-day period to avoid perineal soiling associated with micturition. Perineal cleansing was performed three or four times a day and after each anal emission. Patients were maintained on a clear liquid diet postoperatively and received intravenous analgesics for 72 hours. Patients were hospitalized until perineal healing was complete. The device was activated during a oneday hospital stay by external maneuver on the pump and the patient was taught how to deal with implant. Patients were assessed prospectively every 6 months. They completed 2 validated questionnaires, namely the Fecal Incontinence Score (FIS) and the Fecal Incontinence Quality of Life score (FIQL) questionnaires at one year that were compared to preoperative scores. FIS was determined by asking the patient to provide an assessment of continence and alteration in lifestyle during the previous four weeks. The score ranged from 0 (normal continence) to 120 (maximum incontinence) [6]. The FIQL questionnaire is a 29-item, validated in English [7], exploring 4 separate quality of life (QOL) domains, including lifestyle, coping/behavior, depression/self-perception, and embarrassment. The scale score for a specific domain ranged from 0 (worst QOL imaginable) to a maximum of 4 (higher functional status of QOL). A French version of the FIQL questionnaire has been adapted and validated [8, 9]. Patients were also asked to provide an estimation of overall satisfaction with the operation. They were assessed at a mean 30 months specifically for this report. Stationary anal manometry was performed 12 months after implantation, according to our standard technique with inflated balloons [10]. Measurements of maximal anal resting pressure, with the cuff closed (inflated) and opened (deflated) by the patient, and the time required for the cuff to close were recorded for each patient [11, 12].
Table I. – Characteristics of implanted artificial sphincters. Caractéristiques des sphincters artificiels implantés. Patient 1
Patient 2
Patient 3
Length (cm)
10
11
10
Width (cm)
2.0
2.0
2.0
91-100
91-100
91-100
8
6
5
Balloon pressure (cm H20) Cuff filling (mL)
Activation of the device occured at a mean of 96 days. One patient observed recurrence of leakage at 16 months post-implantation. Radiopaque fluid (4 mL) was reinjected percutaneously through the port placed at the bottom of the control pump, restoring the previous level of continence and satisfaction. For the other 2 patients, continence remained intact and constant over time to date. At a mean 2.5 years follow-up, the 3 patients maintained an activated and functional artificial sphincter. They all had been trained to evacuate colonic contents at definite intervals using retrograde irrigation, following their first surgery of APR and perineal colostomy, and pursued on the same regimen. They were accustomed to filling the colon with about 2 liters of warm tap water with a Foley catheter (N = 2) or conic canula (N = 1) every 2 days. Such regimens were not efficient to avoid leakage before implantation of the artificial sphincter. After implantation, the 3 patients observed the disappearance of leakage, the possibility to interruption of dietary restriction, a greater feeling of freedom and confidence. This translated to improvements in both continence score and quality of life assessment. Improvement in continence was observed as FIS decreased from 81 to 35 (figure 1). No patient reported loss of stools, either solid or liquid, but two patients had no control on flatus. The gains in QOL for each of the 4 domains are presented in figure 2. Two of the patients complained of moderate episodic evacuation difficulties resolved by increasing rate and volume of retrograde enemas. No pain or discomfort in relation to the anal artificial sphincter was observed. Abdominal and perineal scars were healthy. The 3 patients observed a significant improvement in their condition, compared to their functional state prior to implanta-
120
80
Results
Patient 1 Patient 2
There were no intra-operative complications or technical difficulties in implanting the artificial sphincter. In the 3 patients, the tunnels around the pull-through colon were easy to create, without significant bleeding or ischemic consequence. Characteristics of implanted artificial anal sphincters are displayed in table I. Median length of hospital stay was 10 days. In one case, abdominal incision healed by second intention without evidence of infection.
Patient 3
40
0
post-op.
Fig. 1 – Fecal incontinence score before and 12 months after implantation of artificial sphincter. Range: 0 (normal continence) — 120 (worst incontinence). Score d’incontinence fécale avant et 12 mois après implantation du sphincter artificiel. Limites : 0 (continence normale) — 120 (incontinence maximale).
ABBREVIATIONS : APR FIS FIQL QOL
pre-op.
: Abdominoperineal resection : Fecal Incontinence Score : Fecal Incontinence Quality of Life score : Quality Of Life
426
Anorectal reconstruction and artificial sphincter
LIFESTYLE
COPING/BEHAVIOUR
4
4
3
3 2
2 POST-OP
POST-OP
1
1 PRE-OP
0
PRE-OP
0
SELF PERCEPTION
EMBARRASSEMENT
4
4
3
3
2
2
POST-OP
1
1 0
PRE-OP
0
POST-OP PRE-OP
Fig. 2 – Quality-of-life status in the four domains explored before and 12 months after artificial sphincter implantation. a) Lifestyle, b) Coping/behavior, c) Self perception, d) Embarrassment. Etat de la qualité de vie dans les 4 domaines explorés avant et 12 mois après implantation du sphincter artificiel. a) Mode de vie, b) Comportement, c) Dépression et image de soi, d) Gêne vis-à-vis des autres.
tion. They all indicated that they felt more confident, regained a nearly normal level of social activities, and were much less limited in dietary manners. Anal manometry showed that a gradient of pressure (difference between pressure of the inflated cuff and deflated cuff) reached a mean 54 cm H20 (48, 45 and 68 cmH20, respectively). The mean time required to reinflate the cuff after voluntary opening, was 4 min 25 sec (2 min 40 sec, 5 min and 4 min 15 sec, respectively).
3 months and complete healing. For these authors, the sizer elicited fibrosis creating a barrier between the bowel wall and the device, limiting the risk of erosion to the colon. We proved that this step is not necessary for secondary implantation of an artificial sphincter and the technique could be simplified without increased morbidity. This point is of interest in case of delayed implantation of the device, as a second step in the months following APR. The risk of colonic devascularisation secondary to the dissection of the pericolic atmosphere has not been confirmed. Preoperative radiotherapy had no adverse effect in our patients and did not increase operative difficulties or postoperative morbidity, as no local signs of radiation injury (perineum, vagina or colon) were present. Implantation of an artificial sphincter has been performed long after APR in our cases, with patients free of any sign of recurrence and considered as cured from rectal cancer. No fecal diversion was performed as we usually performed for implantation of anal artificial sphincter in incontinence patients. In the series by Romano et al., protective loop ileostomy was constructed at time of anorectal reconstruction and left in place for implantation of the artificial sphincter [5].
Discussion If a pseudocontinent perineal colostomy is considered as a valid option to abdominal stoma following APR, only a minority of patients who benefit from this procedure regains full fecal continence. Even though they feel satisfied, more than half of patients still worry about continence problems [3]. We demonstrate here that a delayed secondary implantation of an artificial sphincter after confection of pseudocontinent perineal colostomy is safe and feasible without significant morbidity. This technique can be beneficial to selected patients in which retrograde colonic enemas do not provide acceptable continence. Selection of the patients for implantation of an artificial sphincter is based on the following criteria: 1) high motivation and total refusal of an abdominal stoma, 2) severe handicap related to fecal incontinence not amenable by medical means, 3) absolute certitude of absence of local or distal recurrence from the initial cancer, 4) absence of local sequelae of radiation therapy. Only one series of 8 implantations of an artificial sphincter after total anorectal reconstruction has been reported to date in the literature [5]. From a technical point of view, Romano et al. [5] described the placement of a plastic sizer around the perineal colostomy and replaced it with the inflatable cuff after 2 or
Mid-term satisfactory fecal continence was obtained in our 3 patients. This had a positive impact on quality of life that maintained over time as already demonstrated for incontinent patients treated with anal artificial sphincter [9]. All four domains of the FIQL improved. As a result of this improvement in their well being, the 3 patients have been actively promoting such a surgical approach in patient stomy support groups to which they belong. Manometric study performed 12 months after implantation, evaluated performance of the remaining artificial sphincter; as sphincter mechanisms have been totally excised at time of APR. The basal pressure-cuff inflated, reflects the capacity of the artificial anal sphincter to recreate an area of high pressure upstream of the cuff. The basal pressure-cuff deflated, reflects the residual “anal” pressure: low, it translates in a broad opening of the cuff, necessary for an easy evacuation. Unlike a high pressure with 427
F. Marchal et al.
the cuff deflated and a short cuff refilling time results in evacuation disorder [5]. Other explanations have to be found for our 2 cases with evacuation problems, as basal pressure-cuff deflated, were low. Motility of the pull-through colon might be impaired or not sufficient for a proper evacuation after several years of retrograde irrigation. This is clearly a case against the confection of a reservoir above a perineal colostomy when implantation of an artificial sphincter is considered. Compared with graciloplasty, implantation of an artificial anal sphincter after total anorectal reconstruction seemed to be easier to perform and generate less morbidity [4, 13]. The cumulative morbidity after graciloplasty in this indication has been reported fairly high, ranging from 40 to 90% [4, 13, 14], with frequent stenosis of the neosphincter compromising functional outcome [4]. In comparison, Romano et al. [5] reported one wound infection and three impaired evacuations in their 9 patients and we reported one wound hematoma in our three patients. To date, all the artificial sphincters appear to be functional. No perineal or colonic ulceration has been observed. Function of the device remains fairly stable over time, even if one of our patients had to have her system refilled, which has been done easily through the port placed at the bottom of the control pump. In conclusion, in this limited and preliminary series, the artificial anal sphincter appeared to be a safe and easy procedure to restore continence after total anorectal reconstruction. Fecal continence and quality of life of patients with pseudocontinent perineal colostomy performed after APR improved following implantation of artificial sphincter.
3. Lasser P, Dube P, Guillot JM, Elias D. Pseudocontinent perineal colostomy following abdominoperineal resection: technique and findings in 49 patients. Eur J Surg Oncol 2001;27:49-53.
4. Rullier E, Zerbib F, Laurent C, Caudry M, Saric J. Morbidity and functional outcome after double dynamic graciloplasty for anorectal reconstruction. Br J Surg 2000;87:909-13.
5. Romano G, La Torre F, Cutini G, Bianco F, Esposito P, Montori A. Total anorectal reconstruction with the artificial bowel sphincter: report of eight cases. Dis Colon Rectum 2003;46:730-4.
6. Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut 1999;44:77-80.
7. Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, et al. Fecal incontinence quality of life scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum 2000;43:9-17.
8. Rullier E, Zerbib F, Marrel A, Amouretti M, Lehur PA. Validation of the French version of the Fecal Incontinence Quality of Life scale (FIQL). Gastroenterol Clin Biol 2004;28:562-8
9. Lehur PA, Zerbib F, Neunlist M, Glemain P, Bruley des Varannes S. Comparison of quality of life and anorectal function after artificial sphincter implantation. Dis Colon Rectum 2002;45:508-13.
10. Roig JV, Villoslada C, Lledo S, Solana A, Buch E, Alos R, et al. Prevalence of pudendal neuropathy in fecal incontinence: results of a prospective study. Dis Colon Rectum 1995;38:952-8.
11. Lehur PA, Roig JV, Duinslaeger M. Artificial anal sphincter: a prospective clinical and manometric evaluation. Dis Colon Rectum 2000;43:1100-6.
12. Savoye G, Leroi AM, Denis P, Michot F. Manometric assessment of an artificial bowel sphincter. Br J Surg 2000;87:586-9.
REFERENCES
13. Cavina E, Seccia M, Banti P, Zocco G. Anorectal reconstruction after
1. Rullier E, Goffre B, Bonnel C, Zerbib F, Caudry M, Saric J. Preoperative radiochemotherapy and sphincter-saving resection for T3 carcinomas of the lower third of the rectum. Ann Surg 2001;234:633-40.
abdominoperineal resection: experience with double-wrap graciloplasty supported by low-frequency electrostimulation. Dis Colon Rectum 1998;41:1010-6.
2. Bretagnol F, Troubat H, Laurent C, Zerbib F, Saric J, Rullier E. Long-
14. Rouanet P, Senesse P, Bouamrirene D, Toureille E, Veyrac M, Astre C.
term functional results after sphincter-saving resection for rectal cancer. Gastroenterol Clin Biol 2004;28:155-9.
Anal sphincter reconstruction by dynamic graciloplasty after abdominal resection for cancer. Dis Colon Rectum 1999;42:451-6.
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25,*,1$/ $57,&/(
Gastroenterol Clin Biol 2005;29:425-428
Secondary implantation of an artificial sphincter after abdominoperineal resection and pseudocontinent perineal colostomy for rectal cancer
Frédéric MARCHAL (1), Carole DOUCET (1), David LECHAUX (2), Philippe LASSER (3), Paul-Antoine LEHUR (1) (1) Clinique chirurgicale II, Pôle digestif, Hôtel Dieu, Place Alexis Ricordeau, 44093 Nantes ; (2) Service de chirurgie digestive, Centre hospitalier, 22000 St Brieuc ; (3) Département de Chirurgie, Institut Gustave Roussy, 39, rue Camille Dumoulin, 94805 Villejuif.
SUMMARY
RÉSUMÉ
Introduction — Fecal continence with a perineal colostomy performed after abdominoperineal resection (APR) is not always satisfactory despite retrograde colonic enemas. Functional improvement is currently examined using artificial sphincters. Preliminary results are disclosed.
Implantation secondaire d’un sphincter artificiel après amputation abdomino-périnéale et colostomie périnéale pseudocontinente pour cancer du rectum Frédéric MARCHAL, Carole DOUCET, David LECHAUX, Philippe LASSER, Paul-Antoine LEHUR (Gastroenterol Clin Biol 2005;29:425-428)
Patients — In 3 female patients, 45, 59 and 68 years old, curative APR and perineal colostomy were performed after radiotherapy in 2, for T1-2N0 cancer of the lower rectum. Due to occasional leaks, need for strict diet and fear of incontinence, an Acticon Neosphincter® (AMS) was implanted consecutively at a mean 4.5 years after APR.
Introduction — En cas de colostomie périnéale réalisée après amputation abdomino-périnéale (AAP), la continence fécale n’est pas toujours satisfaisante. Nous rapportons ici l’implantation de sphincter artificiel pour en améliorer le résultat fonctionnel. Malades — Trois malades, âgées de 45, 59 et 68 ans, avaient été traitées par AAP et colostomie périnéale pour cancer du bas rectum T1-2N0, avec radiothérapie préopératoire dans 2 cas. En raison de mauvais résultats fonctionnels, un sphincter artificiel Acticon Neosphincter (AMS) a été implanté de façon consécutive, en moyenne 4,5 ans après AAP.
Results — Device implantation was feasible and uneventful. In one case, a superficial hematoma was drained and healed by second intention. Devices were activated 3 months after implantation. At a mean 2.5 years follow-up, the 3 patients had an activated and functional artificial sphincter. Leaks and fecal urgency significantly decreased but colonic enemas were maintained. Dietary restrictions were less and quality of life improved. All 3 considered the device as a useful adjunct.
Résultats — L’implantation du matériel n’a pas posé de difficultés. Un hématome sous-cutané a été drainé. Les sphincters ont été activés à 3 mois de l’implantation. A 2,5 ans de suivi médian, les 3 malades avaient un sphincter artificiel activé et fonctionnel. Les fuites et les urgences défécatoires ont été diminuées, mais les irrigations ont été maintenues. Le régime alimentaire n’était plus nécessaire. La qualité de vie était améliorée. Les 3 malades considéraient le sphincter artificiel comme un progrès.
Conclusion — In this limited experience, implantation of artificial sphincter around a perineal colostomy following APR for rectal cancer appeared feasible and safe even in case of previous radiotherapy. Mid-term tolerance was satisfactory. Continence and quality of life significantly improved.
Conclusion — Dans cette série préliminaire, l’implantation d’un sphincter artificiel autour d’une colostomie périnéale après AAP pour cancer du rectum apparaît réalisable et sûre, même en cas de radiothérapie préopératoire. La tolérance à moyen terme est satisfaisante. La continence fécale et la qualité de vie sont significativement améliorées.
P
nence in case of perineal colostomy [4]. However, this technique is associated with a high rate of complications that impairs functional results [4]. The most recent option designed to recreate a sphincteric mechanism after APR and perineal colostomy, consists of the implantation (in the same procedure or as a second step) of an artificial sphincter around the perineal stoma [5]. We reported herein our initial experience of artificial sphincter implanted in patients with unsatisfactory functional results following pseudocontinent perineal colostomy performed after APR.
atients with cancer of lower rectum, with or without involvement of the anal canal, still need to be treated with abdominoperineal resection (APR). Abdominal colostomy represents a definitive condition that alters body image. Such an alteration, however, is unacceptable to some patients, which had led to the development of innovative reconstruction processes. Intersphincteric resection with colonic reservoir and coloanal anastomosis has been shown to give good local control and with acceptable functional results, in selected patients having lesions 2 cm from the anal verge [1, 2]. Creation of a pseudocontinent perineal colostomy is also a means to avoid an abdominal stoma. It can be constructed with or without an auto-transplant of a free flap of colonic muscle around the colon, a few centimeters upstream of the perineal stoma [3]. The use of single or double dynamic (electrostimulated) gracilis muscle is an another method in obtaining a neosphincter and improve conti-
Patients and methods In 2001 and 2002, three consecutive female patients (age 46, 59 and 68 years) had an artificial sphincter (Acticon Neosphincter®, American Medical Systems, Minneapolis, MN, USA) implantation around a Presented as a poster at the 3rd meeting of the European Association of Coloproctology (Erlanguen, Germany- September 13-15, 2002). Supported by a grant from the CEREC (Centre d’Études et de Recherche en Chirurgie) — Nantes.
Reprints : P.-A. LEHUR, Clinique chirurgicale II, Pôle digestif, Hotel Dieu, Place Alexis Ricordeau, 44093 Nantes. E-mail : [email protected]
425
F. Marchal et al.
perineal colostomy. We have previously used the artificial sphincter device to treat patients with fecal incontinence. The 3 patients had curative APR and pseudocontinent perineal colostomy, following radiotherapy in 2, for T1-2, N0 rectal cancer, at respectively 35, 79 and 44 months before artificial sphincter implantation. Despite regular enemas, these 3 patients complained of occasional leaks, a need for a strict diet and restriction in social activities, psychological disturbances related to fear of incontinence and impaired quality of life. To improve their functional status, they accepted the implantation of an artificial sphincter with the knowledge that its use was experimental. Our standard regimen for implantation included preoperative cutaneous and bowel preparation during a 48-hour period before surgery with retrograde enemas, repeated cleansing with an iodinized disinfectant and vaginal irrigation. Antibiotic prophylaxis (aminoside and third generation cephalosporins) was given at induction. Before the onset of surgery, adequacy of the bowel preparation was assessed. The patient was placed in a modified lithotomy position. The occlusive cuff surrounding the colon was placed using one transverse anterior incision. The anterior tunnel was created under direct vision; the posterior tunnel was formed by blunt dissection. The best site of cuff implantation was at distance of 4 cm or more from the skin incision. After completion of the tunnels, a cuff sizer was pulled around the colon to measure the appropriate length and width of the cuff. The reservoir balloon was placed in the prevesical space via a lower transversal abdominal incision and inflated with the appropriate amount of radiopaque fluid. From this incision, the pump was inserted in the upper part of the homolateral labia (left if the patient was right-handed, and vice versa). At completion of the operation, the device was left deactivated for 3 months postoperatively. No stoma was performed. A bladder catheter was placed for a 3-day period to avoid perineal soiling associated with micturition. Perineal cleansing was performed three or four times a day and after each anal emission. Patients were maintained on a clear liquid diet postoperatively and received intravenous analgesics for 72 hours. Patients were hospitalized until perineal healing was complete. The device was activated during a oneday hospital stay by external maneuver on the pump and the patient was taught how to deal with implant. Patients were assessed prospectively every 6 months. They completed 2 validated questionnaires, namely the Fecal Incontinence Score (FIS) and the Fecal Incontinence Quality of Life score (FIQL) questionnaires at one year that were compared to preoperative scores. FIS was determined by asking the patient to provide an assessment of continence and alteration in lifestyle during the previous four weeks. The score ranged from 0 (normal continence) to 120 (maximum incontinence) [6]. The FIQL questionnaire is a 29-item, validated in English [7], exploring 4 separate quality of life (QOL) domains, including lifestyle, coping/behavior, depression/self-perception, and embarrassment. The scale score for a specific domain ranged from 0 (worst QOL imaginable) to a maximum of 4 (higher functional status of QOL). A French version of the FIQL questionnaire has been adapted and validated [8, 9]. Patients were also asked to provide an estimation of overall satisfaction with the operation. They were assessed at a mean 30 months specifically for this report. Stationary anal manometry was performed 12 months after implantation, according to our standard technique with inflated balloons [10]. Measurements of maximal anal resting pressure, with the cuff closed (inflated) and opened (deflated) by the patient, and the time required for the cuff to close were recorded for each patient [11, 12].
Table I. – Characteristics of implanted artificial sphincters. Caractéristiques des sphincters artificiels implantés. Patient 1
Patient 2
Patient 3
Length (cm)
10
11
10
Width (cm)
2.0
2.0
2.0
91-100
91-100
91-100
8
6
5
Balloon pressure (cm H20) Cuff filling (mL)
Activation of the device occured at a mean of 96 days. One patient observed recurrence of leakage at 16 months post-implantation. Radiopaque fluid (4 mL) was reinjected percutaneously through the port placed at the bottom of the control pump, restoring the previous level of continence and satisfaction. For the other 2 patients, continence remained intact and constant over time to date. At a mean 2.5 years follow-up, the 3 patients maintained an activated and functional artificial sphincter. They all had been trained to evacuate colonic contents at definite intervals using retrograde irrigation, following their first surgery of APR and perineal colostomy, and pursued on the same regimen. They were accustomed to filling the colon with about 2 liters of warm tap water with a Foley catheter (N = 2) or conic canula (N = 1) every 2 days. Such regimens were not efficient to avoid leakage before implantation of the artificial sphincter. After implantation, the 3 patients observed the disappearance of leakage, the possibility to interruption of dietary restriction, a greater feeling of freedom and confidence. This translated to improvements in both continence score and quality of life assessment. Improvement in continence was observed as FIS decreased from 81 to 35 (figure 1). No patient reported loss of stools, either solid or liquid, but two patients had no control on flatus. The gains in QOL for each of the 4 domains are presented in figure 2. Two of the patients complained of moderate episodic evacuation difficulties resolved by increasing rate and volume of retrograde enemas. No pain or discomfort in relation to the anal artificial sphincter was observed. Abdominal and perineal scars were healthy. The 3 patients observed a significant improvement in their condition, compared to their functional state prior to implanta-
120
80
Results
Patient 1 Patient 2
There were no intra-operative complications or technical difficulties in implanting the artificial sphincter. In the 3 patients, the tunnels around the pull-through colon were easy to create, without significant bleeding or ischemic consequence. Characteristics of implanted artificial anal sphincters are displayed in table I. Median length of hospital stay was 10 days. In one case, abdominal incision healed by second intention without evidence of infection.
Patient 3
40
0
post-op.
Fig. 1 – Fecal incontinence score before and 12 months after implantation of artificial sphincter. Range: 0 (normal continence) — 120 (worst incontinence). Score d’incontinence fécale avant et 12 mois après implantation du sphincter artificiel. Limites : 0 (continence normale) — 120 (incontinence maximale).
ABBREVIATIONS : APR FIS FIQL QOL
pre-op.
: Abdominoperineal resection : Fecal Incontinence Score : Fecal Incontinence Quality of Life score : Quality Of Life
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Anorectal reconstruction and artificial sphincter
LIFESTYLE
COPING/BEHAVIOUR
4
4
3
3 2
2 POST-OP
POST-OP
1
1 PRE-OP
0
PRE-OP
0
SELF PERCEPTION
EMBARRASSEMENT
4
4
3
3
2
2
POST-OP
1
1 0
PRE-OP
0
POST-OP PRE-OP
Fig. 2 – Quality-of-life status in the four domains explored before and 12 months after artificial sphincter implantation. a) Lifestyle, b) Coping/behavior, c) Self perception, d) Embarrassment. Etat de la qualité de vie dans les 4 domaines explorés avant et 12 mois après implantation du sphincter artificiel. a) Mode de vie, b) Comportement, c) Dépression et image de soi, d) Gêne vis-à-vis des autres.
tion. They all indicated that they felt more confident, regained a nearly normal level of social activities, and were much less limited in dietary manners. Anal manometry showed that a gradient of pressure (difference between pressure of the inflated cuff and deflated cuff) reached a mean 54 cm H20 (48, 45 and 68 cmH20, respectively). The mean time required to reinflate the cuff after voluntary opening, was 4 min 25 sec (2 min 40 sec, 5 min and 4 min 15 sec, respectively).
3 months and complete healing. For these authors, the sizer elicited fibrosis creating a barrier between the bowel wall and the device, limiting the risk of erosion to the colon. We proved that this step is not necessary for secondary implantation of an artificial sphincter and the technique could be simplified without increased morbidity. This point is of interest in case of delayed implantation of the device, as a second step in the months following APR. The risk of colonic devascularisation secondary to the dissection of the pericolic atmosphere has not been confirmed. Preoperative radiotherapy had no adverse effect in our patients and did not increase operative difficulties or postoperative morbidity, as no local signs of radiation injury (perineum, vagina or colon) were present. Implantation of an artificial sphincter has been performed long after APR in our cases, with patients free of any sign of recurrence and considered as cured from rectal cancer. No fecal diversion was performed as we usually performed for implantation of anal artificial sphincter in incontinence patients. In the series by Romano et al., protective loop ileostomy was constructed at time of anorectal reconstruction and left in place for implantation of the artificial sphincter [5].
Discussion If a pseudocontinent perineal colostomy is considered as a valid option to abdominal stoma following APR, only a minority of patients who benefit from this procedure regains full fecal continence. Even though they feel satisfied, more than half of patients still worry about continence problems [3]. We demonstrate here that a delayed secondary implantation of an artificial sphincter after confection of pseudocontinent perineal colostomy is safe and feasible without significant morbidity. This technique can be beneficial to selected patients in which retrograde colonic enemas do not provide acceptable continence. Selection of the patients for implantation of an artificial sphincter is based on the following criteria: 1) high motivation and total refusal of an abdominal stoma, 2) severe handicap related to fecal incontinence not amenable by medical means, 3) absolute certitude of absence of local or distal recurrence from the initial cancer, 4) absence of local sequelae of radiation therapy. Only one series of 8 implantations of an artificial sphincter after total anorectal reconstruction has been reported to date in the literature [5]. From a technical point of view, Romano et al. [5] described the placement of a plastic sizer around the perineal colostomy and replaced it with the inflatable cuff after 2 or
Mid-term satisfactory fecal continence was obtained in our 3 patients. This had a positive impact on quality of life that maintained over time as already demonstrated for incontinent patients treated with anal artificial sphincter [9]. All four domains of the FIQL improved. As a result of this improvement in their well being, the 3 patients have been actively promoting such a surgical approach in patient stomy support groups to which they belong. Manometric study performed 12 months after implantation, evaluated performance of the remaining artificial sphincter; as sphincter mechanisms have been totally excised at time of APR. The basal pressure-cuff inflated, reflects the capacity of the artificial anal sphincter to recreate an area of high pressure upstream of the cuff. The basal pressure-cuff deflated, reflects the residual “anal” pressure: low, it translates in a broad opening of the cuff, necessary for an easy evacuation. Unlike a high pressure with 427
F. Marchal et al.
the cuff deflated and a short cuff refilling time results in evacuation disorder [5]. Other explanations have to be found for our 2 cases with evacuation problems, as basal pressure-cuff deflated, were low. Motility of the pull-through colon might be impaired or not sufficient for a proper evacuation after several years of retrograde irrigation. This is clearly a case against the confection of a reservoir above a perineal colostomy when implantation of an artificial sphincter is considered. Compared with graciloplasty, implantation of an artificial anal sphincter after total anorectal reconstruction seemed to be easier to perform and generate less morbidity [4, 13]. The cumulative morbidity after graciloplasty in this indication has been reported fairly high, ranging from 40 to 90% [4, 13, 14], with frequent stenosis of the neosphincter compromising functional outcome [4]. In comparison, Romano et al. [5] reported one wound infection and three impaired evacuations in their 9 patients and we reported one wound hematoma in our three patients. To date, all the artificial sphincters appear to be functional. No perineal or colonic ulceration has been observed. Function of the device remains fairly stable over time, even if one of our patients had to have her system refilled, which has been done easily through the port placed at the bottom of the control pump. In conclusion, in this limited and preliminary series, the artificial anal sphincter appeared to be a safe and easy procedure to restore continence after total anorectal reconstruction. Fecal continence and quality of life of patients with pseudocontinent perineal colostomy performed after APR improved following implantation of artificial sphincter.
3. Lasser P, Dube P, Guillot JM, Elias D. Pseudocontinent perineal colostomy following abdominoperineal resection: technique and findings in 49 patients. Eur J Surg Oncol 2001;27:49-53.
4. Rullier E, Zerbib F, Laurent C, Caudry M, Saric J. Morbidity and functional outcome after double dynamic graciloplasty for anorectal reconstruction. Br J Surg 2000;87:909-13.
5. Romano G, La Torre F, Cutini G, Bianco F, Esposito P, Montori A. Total anorectal reconstruction with the artificial bowel sphincter: report of eight cases. Dis Colon Rectum 2003;46:730-4.
6. Vaizey CJ, Carapeti E, Cahill JA, Kamm MA. Prospective comparison of faecal incontinence grading systems. Gut 1999;44:77-80.
7. Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, et al. Fecal incontinence quality of life scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum 2000;43:9-17.
8. Rullier E, Zerbib F, Marrel A, Amouretti M, Lehur PA. Validation of the French version of the Fecal Incontinence Quality of Life scale (FIQL). Gastroenterol Clin Biol 2004;28:562-8
9. Lehur PA, Zerbib F, Neunlist M, Glemain P, Bruley des Varannes S. Comparison of quality of life and anorectal function after artificial sphincter implantation. Dis Colon Rectum 2002;45:508-13.
10. Roig JV, Villoslada C, Lledo S, Solana A, Buch E, Alos R, et al. Prevalence of pudendal neuropathy in fecal incontinence: results of a prospective study. Dis Colon Rectum 1995;38:952-8.
11. Lehur PA, Roig JV, Duinslaeger M. Artificial anal sphincter: a prospective clinical and manometric evaluation. Dis Colon Rectum 2000;43:1100-6.
12. Savoye G, Leroi AM, Denis P, Michot F. Manometric assessment of an artificial bowel sphincter. Br J Surg 2000;87:586-9.
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