Dynamic Graciloplasty Research Articles

Outcomes of graciloplasty in the treatment of fecal incontinence: a systematic review and meta-analysis of the literature.

Patients with refractory fecal incontinence symptoms can be treated with several surgical procedures including graciloplasty. Reported outcomes and morbidity rates of this procedure are highly variable. The aim of this study was to assess continence rate and safety of dynamic and adynamic graciloplasty. PubMed and Google Scholar databases were systematically searched from inception until January 2022 according to preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines. Reviews, animal studies, studies with patients < 18years or < 10 patients, with no success rate reported or non-English text, were excluded. Main outcome measures were overall continence and morbidity rates of each technique. Fourteen studies were identified, incorporating a total of 450 patients (337 females), published between 1980 and 2021. Most common etiology of incontinence (35.5%-n = 160) was obstetric trauma followed by anorectal trauma (20%-n = 90). The weighted mean rate of continence after dynamic graciloplasty was 69.1% (95% CI 0.53-0.84%, I2 = 90%) compared to 71% (95% CI 0.54-0.87, I2 = 82.5%) after adynamic. Although the weighted mean short-term complication rate was lower in the dynamic group (26% versus 40%), when focusing on complications requiring intervention under general anesthesia, there was a much higher incidence (43.4% versus 10.5%) in the dynamic group. The weighted mean rate of long-term complications was 59.4% (95% CI 0.13-1.04%, I2 = 97.7%) in the dynamic group, almost twice higher than in the adynamic group [30% (95% CI - 0.03 to 0.63), I2 = 95.8%]. Median follow-up ranged from 1 to 13years. Our data suggest that graciloplasty may be considered for incontinent patients. Dynamic graciloplasty may harbor higher risk for reoperation and complications compared to adynamic.The fact that the functional results between adynamic and dynamic graciloplasty are equivalent and the morbidity rate of adynamic graciloplasty is significantly lower reinforce the graciloplasty as an option to treat appropriately selected patients with fecal incontinence.

Replacement Adaptor 09106 for patients with a dynamic graciloplasty or patients with sacral neuromodulation and abdominal implantable pulse generators: a retrospective, single centre, Stage 2a/2b development IDEAL case series.

Due to the introduction of a new implantable pulse generator (IPG), the Interstim II, patients with either a dynamic graciloplasty or an abdominally placed IPG for sacral neuromodulation could not undergo surgery to replace their IPG in the case of end of battery life. For these patients, the Medtronic Replacement Adaptor 09106 was created. This retrospective case series aims to study safety and feasibility of the Medtronic Replacement Adaptor 09106 in patients with abdominally placed IPGs. Seventeen patients (11 women, six men) received a replacement adaptor with a follow-up of 6months. Outcome measures consisted of a bowel habit diary. Adverse events were classified using the Clavien-Dindo classification. Outcome measures in the bowel habit diaries after replacement (feasibility) did not differ significantly from outcome measures before replacement. Adverse events occurred in four out of 17 patients (24%): two patients initially showed pocket site pain (Clavien-Dindo Grade I), which resolved without intervention. One patient suffered from poor wound closure (Clavien-Dindo Grade II) and one patient had persisting pocket pain (Clavien-Dindo Grade IIIa) for which a pocket revision was performed. Statistical analyses were performed making paired comparisons using a Wilcoxon signed rank test. The Medtronic Replacement Adaptor 09106 is a valuable option for patients with dynamic graciloplasty or sacral neuromodulation and abdominal IPG and has complication rates similar to replacement of the Interstim without Replacement Adaptor 09106.

Long-term results of dynamic graciloplasty for severe fecal incontinence

Fecal incontinence is a common complaint. In the presence of extensive sphincter deterioration, after anorectal trauma, or failure of non-invasive surgical procedures, a sphincter reconstruction with dynamic graciloplasty can be proposed. The aim of our study was to evaluate the long-term results of dynamic graciloplasty. A retrospective study was conducted on all the patients who underwent dynamic graciloplasty between 1997 and 2019 in one French tertiary referral center for severe fecal incontinence after previous unsuccessful treatments. Only patients with available long-term results (≥ 1year) were included. Among 40 patients who underwent dynamic graciloplasty, 31 patients [77% women, median age = 57years (range 17-74years)] were included with a meanlong-term follow-up of 11 ± 6years. The mean duration of fecal incontinence was 8 ± 7.9years and the mean Wexner score was 16 ± 3. Fecal incontinence was adult-acquired in 88% of patients. 74% of patients underwent previously unsuccessful surgical procedures. A diverting colostomy was present in 7 patients (23%). Postoperative overall, surgical and major morbidity occurred in 20 (64%), 17 (55%) and 7 (23%) patients, respectively. At the end of follow-up, 18 patients still used their stimulation device (58%), and 4 patients required a permanent colostomy (12.5%). Long-term efficacy of dynamic graciloplasty was reported by 17 patients (55%). The efficacy of dynamic graciloplasty is conserved in 55% of patients after a mean follow-up of 11years. This procedure needs to be kept in the surgical armamentarium for persistent and severe fecal incontinence after previous surgical interventions or in the presence of large perineal defects, before the ultimate step of permanent stoma.

Long-Term Outcome after Dynamic Graciloplasty for Treatment of Persistent Fecal Incontinence in Patients with Anorectal Malformations.

Dynamic graciloplasty (DGP) has been used to treat severe fecal incontinence since the 1980s. Previous studies have shown an inferior outcome in patients with anorectal malformations (ARMs). Our experience has been that DGP has been appreciated by ARM -patients. The objective of the study was to evaluate the long-term outcome of DGP in our patients with ARM compared with patients with other underlying conditions. Twenty-three patients operated with DGP at our institution from 1996 to 2010 were sent validated bowel function and quality of life questionnaires. Eighteen of 23 responded. Seven had ARM and 11 had other etiologies of fecal incontinence. The mean follow-up time was 11.6 years (range, 5-17). Four of 7 of the patients with ARM and 8 of 11 of patients with other etiologies used their implants at follow-up. The Miller incontinence score was slightly higher for patients with ARMs, but they had less constipation and higher Fecal Incontinence Quality of Life (FIQL)- and 36-Item Short Form Health Survey (SF-36) scores. None of the differences were statistically significant. This study cannot confirm earlier reports in which DGP has an inferior outcome in patients with ARM. We therefore believe that the procedure should remain a treatment option for selected patients.

Surgical Interventions and the Use of Device-Aided Therapy for the Treatment of Fecal Incontinence and Defecatory Disorders

The purpose of this clinical practice update expert review is to describe the key principles in the use of surgical interventions and device-aided therapy for managing fecal incontinence (FI) and defecatory disorders. The best practices outlined in this review are based on relevant publications, including systematic reviews and expert opinion (when applicable). Best Practice Advice 1: A stepwise approach should be followed for management of FI. Conservative therapies (diet, fluids, techniques to improve evacuation, a bowel training program, management of diarrhea and constipation with diet and medications if necessary) will benefit approximately 25% of patients and should be tried first. Best Practice Advice 2: Pelvic floor retraining with biofeedback therapy is recommended for patients with FI who do not respond to the conservative measures indicated above. Best Practice Advice 3: Perianal bulking agents such as intra-anal injection of dextranomer may be considered when conservative measures and biofeedback therapy fail. Best Practice Advice 4: Sacral nerve stimulation should be considered for patients with moderate or severe FI in whom symptoms have not responded after a 3-month or longer trial of conservative measures and biofeedback therapy and who do not have contraindications to these procedures. Best Practice Advice 5: Until further evidence is available, percutaneous tibial nerve stimulation should not be used for managing FI in clinical practice. Best Practice Advice 6: Barrier devices should be offered to patients who have failed conservative or surgical therapy, or in those who have failed conservative therapy who do not want or are not eligible for more invasive interventions. Best Practice Advice 7: Anal sphincter repair (sphincteroplasty) should be considered in postpartum women with FI and in patients with recent sphincter injuries. In patients who present later with symptoms of FI unresponsive to conservative and biofeedback therapy and evidence of sphincter damage, sphincteroplasty may be considered when perianal bulking injection and sacral nerve stimulation are not available or have proven unsuccessful. Best Practice Advice 8: The artificial anal sphincter, dynamic graciloplasty, may be considered for patients with medically refractory severe FI who have failed treatment or are not candidates for barrier devices, sacral nerve stimulation, perianal bulking injection, sphincteroplasty and a colostomy. Best Practice Advice 9: Major anatomic defects (eg, rectovaginal fistula, full-thickness rectal prolapse, fistula in ano, or cloaca-like deformity) should be rectified with surgery. Best Practice Advice 10: A colostomy should be considered in patients with severe FI who have failed conservative treatment and have failed or are not candidates for barrier devices, minimally invasive surgical interventions, and sphincteroplasty. Best Practice Advice 11: A magnetic anal sphincter device may be considered for patients with medically refractory severe FI who have failed or are not candidates for barrier devices, perianal bulking injection, sacral nerve stimulation, sphincteroplasty, or a colostomy. Data regarding efficacy are limited and 40% of patients had moderate or severe complications. Best Practice Advice 12: For defecatory disorders, biofeedback therapy is the treatment of choice. Best Practice Advice 13: Based on limited evidence, sacral nerve stimulation should not be used for managing defecatory disorders in clinical practice. Best Practice Advice 14: Anterograde colonic enemas are not effective in the long term for management of defecatory disorders. Best Practice Advice 15: The stapled transanal rectal resection and related procedures should not be routinely performed for correction of structural abnormalities in patients with defecatory disorders.

Reconstruction of the Urethral Sphincter with Dynamic Graciloplasty in a Male Rabbit Model

Introduction: The use of artificial urinary sphincters can improve urinary incontinence after radical prostatectomies; however, complications can arise. We hypothesized that dynamic graciloplasty improves urethral sphincter reconstruction. Materials and Methods: Models of urethral sphincter muscle reconstruction were developed in 5 adult rabbits by wrapping the gracilis muscle flap around the urethra. Intra-urethral pressure was measured in each of the models before reconstruction (control), after reconstruction, and after electrical stimulation of the flap in reconstructed models (stimulated models). Results: The mean maximum urethral closure pressure was significantly greater in the reconstruction model (69.7 (66.5-115.8) mm Hg) than in the control model (39.2 (33.7-49.6) mm Hg). The mean integral of the urethral pressure and urethral length was also significantly greater in the reconstruction model than in the control model. Furthermore, sphincter tightening was enhanced by the electrical stimulation of the flap. Conclusions: Our results support our hypothesis that the functional reconstruction of urethral sphincters using muscle flaps is promising for the treatment of urinary incontinence.

Other options in the treatment of fecal incontinence

Fecal incontinence (FI) is a debilitating condition. Luckily, there are several new treatment options recently introduced or being introduced in the near future. Conservative or “non-operative” management of FI is the first step in management of a patient suffering from FI. Retrograde colonic irrigation is one alternative and is especially valuable in patients suffering from concomitant constipation. Anal plugs are disposable devices that control continence by blocking the passage of stool and may be helpful in selected groups of patients. Sacral nerve stimulation is widely used in the treatment of patients with FI and surgical repair of internal and external procidentia in patients with fecal incontinence has recently gained more interest. At the same time, dynamic graciloplasty and artificial bowel sphincter are rarely used any longer in the management of these patients. There are several treatments that are yet not FDA approved for treatment of patients with FI. The Magnetic anal reinforcement system is a novel device designed to augment the native anal sphincter. This treatment option has demonstrated good results in limited sized series of patients. The post-anal sling procedure, Topas™, has a concept similar to the TVT procedure for urinary stress incontinence. The sling is implanted dorsal to the anal canal with the aim to augment the puborectalis muscle and to restore a normal anorectal angle and a better anal sphincter function. An FDA regulated trial is presently conducted in the US. Regenerative medicine, stem cell therapy, may be the ultimate option to treat FI by regenerating impaired anal muscle. There are currently no validated techniques using this approach but there is an active research ongoing.

A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence

Fecal incontinence is a common problem in community-dwelling women. Prevalence rates range from 12% to 25%. The average age at onset is between 47 and 55 years. This condition is debilitating and emotionally devastating. Most women with fecal incontinence are socially isolated and do not seek care. Although the cause of fecal incontinence is multifactorial, there is often a history of damage to the pelvic region caused by pregnancy and childbirth, Contributory causes include congenital, neurologic, functional, and traumatic alterations of the continence mechanism. Current nonsurgical treatment options for fecal incontinence include antidiarrheal agents, fiber supplements, biofeedback therapy, passive anal barriers, and injectable agents. All have shortcomings in efficacy, morbidity, cost, and/or patient compliance. Surgical options such as anal sphincteroplasty, dynamic graciloplasty, and the artificial anal sphincter have higher morbidity than noninvasive treatments, and long-term results are disappointing. A nonsurgical vaginal bowel-control system (Eclipse System) was recently approved by the Food and Drug administration and is now available. The Eclipse System provides a low-risk, effective, and easily reversible treatment for fecal incontinence. This device consists of a vaginal insert and pressure-regulated pump that reversibly occludes the distal rectum, allowing the patient to control her own bowel movements. The aim of this prospective, open-label trial was to assess the effectiveness and safety of the Eclipse system in women with fecal incontinence. Women with a history of fecal incontinence for at least 6 months and a minimum of 4 incontinence episodes over 2 weeks were fitted with the device. Patients served as their own controls. The primary efficacy outcome was defined as a 50% or greater reduction in fecal incontinence episodes at 1 month and was assessed using a bowel diary. Participants successfully completing 1 month of use were invited into an optional extended-wear period of another 2 months. Secondary outcomes were validated measures of symptom improvement: the Fecal Incontinence Quality of Life scale, the Modified Manchester Health Questionnaire, and the Patient Global Impression of Improvement. Device-related adverse events were recorded. The intention-to-treat population was defined as all participants successfully fitted with the device. The per-protocol population included intention-to-treat participants with a valid 1-month treatment diary. A total of 110 participants from 6 clinical sites entered the fitting assessment. Of these, 61 (55.5%) were successfully fit and underwent treatment. At 1 month, treatment success was demonstrated in 78.7% (48/61) of participants in the intention-to-treat population and 85.7 (48/56) of those in the per-protocol population (both comparisons, P < 0.001). More than 85% of patients considered bowel symptoms to be very much better (57.1%) or much better (28.6%). There was also significant improvement at 1 month in all Fecal Incontinence Quality of Life (P < 0.001) and Modified Manchester (P ≤ 0.007) subscales. Nearly 90% of participants were satisfied with the device, and 98.2% would recommend it to others. There were no serious device-related adverse events; the most common study-wide event reported by 22.7% of women was pelvic cramping or discomfort. The majority (64%) of adverse events occurred during the fitting period. This nonsurgical bowel-control device offers a completely new treatment option for women with fecal incontinence. Women successfully fitted and treated with the device show significant improvement in fecal incontinence symptoms assessed by objective and subjective measures. The device is effective in most patients and has no serious adverse effects. Patient acceptance and satisfaction are high. A longer-term outcome study is being designed to provide additional information on potential adverse effects and tolerability as well as efficacy.

Neurostimulated levator augmentation--a new approach in restoring continence.

Restoration of continence remains a major challenge in patients after abdominoperineal rectal excision (APE) or with end-stage fecal incontinence. A new surgical technique, the neurostimulated levator augmentation, was introduced for pelvic floor augmentation using dynamic graciloplasty in order to restore anorectal angulation. The aim of this study was to assess feasibility and efficiency. From November 2009 to March 2014, n = 17 patients underwent neurostimulated levator augmentation (n = 10 after APE, n = 5 intractable idiopathic fecal incontinence, n = 2 traumatic anal amputation). Gracilis muscle was transposed through the obturator foramen into the pelvic cavity, positioned in a U-shaped sling behind the rectum, fixed to the contralateral os pubis to restore anorectal angulation, and then conditioned by neurostimulation. Questionnaires analyzing function and quality of life were administered. For neurostimulated levator augmentation, four patients suffered from complications that needed operative intervention (n = 3 wound infection, n = 1 colon perforation); three pharmacological treatment and two complications needed no further invasive intervention. One patient died due to causes unrelated to the operation, and no complication required intensive care management. Fecal incontinence in patients with idiopathic incontinence improved significantly after surgery as well as incontinence episodes, urgency, and disease-specific quality of life through all dimensions. Generic quality of life was significantly better after surgery in all patients. After median follow-up of 17months (2-45), all but one patient would undergo the procedure again. Neurostimulated levator augmentation was feasible in all patients with acceptable morbidity. It may represent a new therapeutic option in selected patients with intractable fecal incontinence.

Dynamic versus Adynamic Graciloplasty in Treatment of End-Stage Fecal Incontinence: Is the Implantation of the Pacemaker Really Necessary? 12-Month Follow-Up in a Clinical, Physiological, and Functional Study.

Purpose. The aim of the study is to compare functional results of end-stage fecal incontinence treatment with dynamic graciloplasty and adynamic graciloplasty augmented with transanal conditioning of the transposed muscle. Methods. A total of 20 patients were qualified for graciloplasty procedure due to end-stage fecal incontinence. 7 patients underwent dynamic graciloplasty (DGP), whereas 13 patients were treated with adynamic graciloplasty, with transanal stimulation in the postoperative period (AGP). Clinical, functional, and quality of life assessments were performed 3, 6, and 12 months after the procedures. Results. There were no intraoperative or early postoperative complications. The detachment of gracilis muscle tendon was observed in one patient in DGP group and two in AGP group. There was a significant improvement of Fecal Incontinence Quality of Life (FIQL) and Fecal Incontinence Severity Index (FISI) scores in both groups 12 months after procedure. Anorectal manometry showed improvement regarding basal and squeeze pressures in both groups, with significantly better squeeze pressures in AGP group. Conclusions. The functional effects in the DGP and AGP groups were similar. Significantly lower price of the procedure and avoidance of implant-related complication risk suggest the attractiveness of the AGP method augmented by transanal stimulation.

Anatomic basis of anorectal reconstruction by dynamic graciloplasty with pudendal nerve anastomosis.

Dynamic graciloplasty has been proposed for anal reconstruction, but this method has 2 major drawbacks. First, an electrical device is required for control of the gracilis. The anastomosis with the pudendal nerve will provide more physiological control. Second, the limitation in the mobility of the muscle flap results in wrapping the anal canal with the muscle's distal portion, which is tendonlike and inelastic. Enhancing the mobility of the muscle flap will enable wrapping with the proximal, muscle-like, and extensible portion, possibly providing better sphincteric function. However, the basis for such an operative method is lacking. The aim of this study is to provide the basis for the refined method of anal sphincter reconstruction by dynamic graciloplasty with pudendal nerve anastomosis and to verify the feasibility of lengthening the nerve to the gracilis muscle flap by dissecting into the muscle belly, detaching the gracilis muscle from its origin, and enhancing the mobility of the muscle flap. This is a retrospective, descriptive study. The results from the anatomical study on 9 cadavers are reported. Tension-free anastomosis of the pudendal nerve and nerve to the gracilis was successfully performed in all the 9 cases: in 2 cases, by lengthening the nerve. The detachment of the muscle origin improved the mobility of the muscle flap, and the more proximal portion could be used for wrapping the anal canal, as confirmed in 4 cases. The limited number of cases was a shortcoming of this study. By lengthening the nerve to the muscle, the gracilis can be used for anal sphincter reconstruction with pudendal nerve anastomosis, negating the need for an electrical device. By detaching the origin of the gracilis muscle, its proximal portion can be used to wrap the anal canal, possibly enabling a longer functional canal with stronger constricting force and better vascularity. These modifications to past methods may improve fecal continence after the operation.

Current and Emerging Treatment Options for Fecal Incontinence

Fecal incontinence (FI) is a multifactorial disorder that imposes considerable social and economic burdens. The aim of this article is to provide an overview of current and emerging treatment options for FI. A MEDLINE search was conducted for English-language articles related to FI prevalence, etiology, diagnosis, and treatment published from January 1, 1990 through June 1, 2013. The search was extended to unpublished trials on ClinicalTrials.gov and relevant publications cited in included articles. Conservative approaches, including dietary modifications, medications, muscle-strengthening exercises, and biofeedback, have been shown to provide short-term benefits. Transcutaneous electrical stimulation was considered ineffective in a randomized clinical trial. Unlike initial studies, sacral nerve stimulation has shown reasonable short-term effectiveness and some complications. Dynamic graciloplasty and artificial sphincter and bowel devices lack randomized controlled trials and have shown inconsistent results and high rates of explantation. Of injectable bulking agents, dextranomer microspheres in non-animal stabilized hyaluronic acid (NASHA Dx) has shown significant improvement in incontinence scores and frequency of incontinence episodes, with generally mild adverse effects. For the treatment of FI, conservative measures and biofeedback therapy are modestly effective. When conservative therapies are ineffective, invasive procedures, including sacral nerve stimulation, may be considered, but they are associated with complications and lack randomized, controlled trials. Bulking agents may be an appropriate alternative therapy to consider before more aggressive therapies in patients who fail conservative therapies.

What’s New in the Toolbox for Constipation and Fecal Incontinence?

Constipation and fecal incontinence (FI) are common complaints predominantly affecting the elderly and women. They are associated with significant morbidity and high healthcare costs. The causes are often multi-factorial and overlapping. With the advent of new technologies, we have a better understanding of their underlying pathophysiology which may involve disruption at any levels along the gut–brain–microbiota axis. Initial approach to management should always be the exclusion of secondary causes. Mild symptoms can be approached with conservative measures that may include dietary modifications, exercise, and medications. New prokinetics (e.g., prucalopride) and secretagogues (e.g., lubiprostone and linaclotide) are effective and safe in constipation. Biofeedback is the treatment of choice for dyssynergic defecation. Refractory constipation may respond to neuromodulation therapy with colectomy as the last resort especially for slow-transit constipation of neuropathic origin. Likewise, in refractory FI, less invasive approach can be tried first before progressing to more invasive surgical approach. Injectable bulking agents, sacral nerve stimulation, and SECCA procedure have modest efficacy but safe and less invasive. Surgery has equivocal efficacy but there are promising new techniques including dynamic graciloplasty, artificial bowel sphincter, and magnetic anal sphincter. Despite being challenging, there are no short of alternatives in our toolbox for the management of constipation and FI.

Surgical approaches to fecal incontinence in the adult

Surgical treatment of anal incontinence is indicated only for patients who have failed medical treatment. Sphincterorraphy is suitable in case of external sphincter rupture. In the last decade, sacral nerve stimulation has proven to be a scientifically validated solution when no sphincter lesion has been identified and more recently has also been proposed as an alternative in cases of limited sphincter defect. Anal reconstruction using artificial sphincters is still under evaluation in the literature, while indications for dynamic graciloplasty are decreasing due to its complexity and high morbidity. Less risky techniques involving intra-sphincteric injections are being developed, with encouraging preliminary results that need to be confirmed especially in the medium- and long-term. Antegrade colonic enemas instilled via cecostomy (Malone) can be an alternative to permanent stoma in patients who are well instructed in the techniques of colonic lavage. Stomal diversion is a solution of last resort.

Sacral neuromodulation for bowel dysfunction

Bowel dysfunction generally refers to a variety of clinical conditions including fecal incontinence, constipation, and chronic pelvic pain. Fecal incontinence is the uncontrolled loss of stool, either liquid or solid. Its true prevalence in the adult population is unknown, but might be as high as 5 % if based on a Cleveland Clinic score above 5/20 [1]. The resulting handicap is responsible for social isolation and reduced quality of life. First treatment should be dietary measures, medication, and biofeedback physiotherapy. Surgery is indicated when conservative treatment fails. Direct sphincter repair is suggested in the case of limited total sphincter rupture, but results deteriorate over time, with only around 50 % of patients still continent at long-term follow-up. Sphincter substitution is indicated in patients with large sphincter defects or a severely disrupted sphincter and in the case of failure of other surgical treatment. Non-stimulated graciloplasty (the so-called Pickrell’s procedure) has been abandoned because of the fatigability of the transposed muscle [2]. Dynamic graciloplasty is nowadays very rarely proposed in the treatment of fecal incontinence because the technique is complex, expensive and has a high morbidity rate [3]. Despite a certain level of expertise, our results with the artificial bowel sphincter, like other authors have recently shown, are less promising than those previously published in the literature [4]. Sacral nerve modulation, first developed for the treatment of urinary dysfunction, is another option that has proved to be effective in the treatment of fecal incontinence in patients with an intact or nearly intact sphincter complex [5]. Some authors have demonstrated that sacral neuromodulation could also be beneficial in patients with sphincter defects, in patients presenting with fecal incontinence following anterior resection and chemoradiation for rectal cancer, and in patients suffering from systemic sclerosis or Crohn’s disease. After implantation, 41–75 % of patients achieve complete fecal continence and 75–100 % experience improvement in episodes of incontinence [5]. A few studies have also reported efficacy of sacral neuromodulation in patients suffering from double incontinence, the urinary incontinence being due to either urge incontinence (involuntary urine leakage following urgency), stress incontinence (involuntary urine leakage during efforts), or mixed (associating both urge and stress incontinence) [6, 7]. These functional results are obtained with a reasonable, moderate level of complications [8, 9]. We published the number and causes of reoperation from a series of 87 consecutive patients operated on in a single institution. Among these patients, 36 had surgical revision of the device for the following reasons: device-related failure due to infection in 4 (successful reimplant in 4), electrode displacement in 2, electrode breakage in 2 (reimplantation of electrode in 4), and dysfunction owing to impedance increase in the system in 4; adverse stimulation with pain in 7 (stimulator repositioning in 4 and explantation in 3); battery depletion either spontaneously (n = 6) or owing to an MRI examination (n = 2); total or partial loss of clinical efficacy in 9 (removal of the generator and electrode). In total, nearly 40 % of patients needed a revision of their stimulator, but some of the reoperations were due to the learning curve, the patients in question having been the very first patients being included in the study. A position statement, based on a collective experience of French J.-L. Faucheron (&) G. Martin Colorectal Unit, Department of Surgery, University Hospital, CS 10217, B.P. 217, 38043 Grenoble Cedex, France e-mail: JLFaucheron@chu-grenoble.fr

Cost‐effectiveness analysis of sacral neuromodulation for faecal incontinence in the Netherlands

Sacral neuromodulation (SNM) plays a major part in the algorithm of management of faecal incontinence, but there are limited data on its cost-effectiveness. This study aimed to analyse this and the quality-adjusted life-years (QALYs) associated with two different treatment algorithms. The first (SNM-) included use of an artificial sphincter [dynamic graciloplasty (DGP) (50%) and artificial bowel sphincter (ABS) (50%)]. The second (SNM+) included SNM (80% of cases) and artificial sphincter (DGP 10%; ABS 10%) The incidence of sphincteroplasty was assumed to be equal in both algorithms. A Markov model was developed. A hypothetical cohort of patients was run through both strategies of the model. A mailed EuroQoL-5D questionnaire was used to determine health-related quality of life. Costs were reproduced from the Maastricht University Medical Centre prospective faecal incontinence database. The time scale of the analysis was 5 years. The former treatment protocol cost €22,651 per patient and the latter, after the introduction of SNM, cost €16,473 per patient. The former treatment protocol resulted in a success rate of 0.59 after 5 years, whereas with the introduction of SNM this was 0.82. Adhering to the former treatment protocol yielded 4.14 QALYs and implementing the latter produced 4.21 QALYs. The study demonstrated that introducing SNM in the surgical management algorithm for faecal incontinence was both more effective and less costly than DGP or ABS without SNM. This justifies adequate funding for SNM for patients with faecal incontinence.

Incontinencia fecal del adulto

Fecal incontinence in adults The aim of this paper is to review the knowledge of this pathology by highlighting the clinical evolution, study and treatment. These different aspects need a multidisciplinary approach, because of their complex physiopathology, possible association with urinary incontinence and prolapse of the three compartments of the pelvis. The fecal incontinence (FI) constitutes a highly prevalent pathology that affects at least 2% of the population and up to 45% of the patients in nursing homes. This pathology can cause serious problems in physical, psychological, social, and economical levels. The clinical evaluation may identify or suspect the cause, and guide the study of FI. The initial treatment of the FI should always be medical one, often associa- ted to biofeedback and the surgical treatment should be only reserved for refractory FI. Sphincteroplasty is indicated by defi ned defaults of the external sphincter, with good initial results (at least 70%) that fall to 50% in 5 years. The artifi cial neosphincter and the dynamic graciloplasty represent an option for patient without suffi cient sphincter mass for a plasty. In the last few years new techniques have appear with promising re- sults, as the neuromodulation that uses electrodes in the sacral plexus or applied to the posterior tibial nerve. In conclusion the IF is a problem of large prevalence but kept in shadows because the patients tend to have reticence to declare it, and the doctors to inquire about. The focus should be multidisciplinary and the initial treatment must be medical one. The surgical treatment should be reserved for refractory FI.

Total perineal reconstruction after abdominoperineal excision for rectal cancer: long‐term results of dynamic graciloplasty with Malone appendicostomy

This study aimed to assess long-term function after total perineal reconstruction (TPR) with dynamic graciloplasty (DG) and systematic Malone appendicostomy (MA) adjunction after abdominoperineal excision (APR) for rectal cancer. From 1999 to 2004, TPR using DG and MA was performed in 10 patients [seven women; median age 40 (range 28-55) years] after APR for rectal cancer (cT2 in one patient, cT3 in six patients and cT4 in three patients). We prospectively recorded early and late morbidity, mortality, oncological outcome, functional results (using the modified Working Party on Anal Sphincter Replacement 'WPASR' scoring system) and quality of life (QoL; using the European Organisation for Research and Treatment of Cancer 'EORTC' QLQ-C30 and QLQ-CR38 questionnaires). There was no procedure-related mortality. One patient required intra-abdominal re-operation. Nine patients required local and multiple revisions [there was one coloperineal anastomosis (CPA) stenosis, five CPA mucosal prolapse, three stenosis related to graciloplasty, two MA stenosis and one MA reflux]. After a median follow up of 78 months, there was no local recurrence and six patients were alive and disease-free. Regarding the functional results, the median modified WPASR score, of 8, after a follow up of 78 months, was good. The overall QoL scores remained stable over time. In carefully selected patients who want to avoid definitive abdominal colostomy after APR for rectal cancer, reconstruction involving MA and DG after APR for low rectal cancer is followed by good long-term function and QoL.

Advances in the Treatment of Fecal Incontinence

Fecal incontinence (FI) is a distressing condition affecting a great number of patients. Its etiology is often multifactorial and cannot always be determined despite anorectal physiology testing or anal sphincter imaging. Severity scores combined with quality-of-life scores are useful to evaluate and compare treatment outcomes. Medical treatment to regulate bowel transit is helpful but other medications, such as topical perianal agents or antidepressants, have failed to demonstrate any efficacy. Biofeedback is widely used even if its superiority over simple conservative treatment is not apparent in systematic reviews. A variety of injectable sphincter bulking agents have been proposed with modest results. The major advance in the treatment of FI is the advent of sacral nerve stimulation (sacral neuromodulation) supported by a growing body of solid evidence for short and midterm efficacy. Indications for sacral nerve stimulation are expanding continuously and in many centers include patients with sphincter defects. This has raised a debate around the place of sphincterplasty in the treatment of FI especially as long term follow-up studies show significantly declining success rates after 5-10 years. More complex reconstructive procedures, such as dynamic graciloplasty and artificial bowel sphincters are still valid options for severe FI with non-negligible morbidity but good outcomes in expert centers and motivated patients. This paper reviews the current status of the above-mentioned and other treatment options for FI.

Malone appendicostomy: an unexpected complication

The Malone appendicostomy is a novel option for surgical management of faecal incontinence and chronic constipation, by permitting the administration of antegrade colonic enemas for colonic evacuation. We report the case of a 54-year-old female who had undergone abdomino perineal resection for low rectal cancer followed by total perineal reconstruction with perineal colostomy, dynamic double graciloplasty and Malone appendicostomy. After 7-year follow-up, functional results and quality of life scores were satisfactory. Suddenly the patient described increasing difficulty with intubation of her appendicostomy and complete reflux of the enema liquid, which radiology referred to a calcified body of 35 mm within the Malone appendicostomy causing nearly complete obstruction of the conduit. A surgical exploration was necessary to extract the fecolith allowing full recovery with return to satisfactory Malone appendicostomy function. To our knowledge, this is the first report of a fecolith causing obstruction within a Malone appendicostomy.