Skeletal Muscle-Derived Cell Implantation for the Treatment of Fecal Incontinence: A Randomized, Placebo-Controlled Study.

BACKGROUND AND AIMS: Fecal incontinence (FI) improvement following injection of autologous skeletal muscle-derived cells has been previously suggested. This study aimed to test the efficacy and safety of said cells through a multicenter, placebo-controlled study, to determine an appropriate cell dose, and to delineate the target patient population that can most benefit from cell therapy. METHODS: Patients experiencing FI for at least 6 months were randomized to receive a cell-free medium or low or high dose of cells. All patients received pelvic floor electrical stimulation before and after treatment. Incontinence episode frequency (IEF), FI quality of life, FI burden assessed on a visual analog scale, Wexner score, and parameters reflecting anorectal physiological function were all assessed for up to 12 months. RESULTS: Cell therapy improved IEF, FI quality of life, and FI burden, reaching a preset level of statistical significance in IEF change compared with the control treatment. Post hoc exploratory analyses indicated that patients with limited FI duration and high IEF at baseline are most responsive to cells. Effects prevailed or increased in the high cell count group from 6 to 12 months but plateaued or diminished in the low cell count and control groups. Most physiological parameters remained unaltered. No unexpected adverse events were observed. CONCLUSIONS: Injection of a high dose of autologous skeletal muscle-derived cells followed by electrical stimulation significantly improved FI, particularly in patients with limited FI duration and high IEF at baseline, and could become a valuable tool for treatment of FI, subject to confirmatory phase 3 trial(s). (ClinicalTrialRegister.eu; EudraCT Number: 2010-021463-32).

Ten-year Evaluation of a Large Retrospective Cohort Treated by Sacral Nerve Modulation for Fecal Incontinence: Results of a French Multicenter Study.

OBJECTIVE: The aim of this study was to assess the effectiveness of sacral nerve modulation (SNM) in a large cohort of patients implanted for at least 10 years, quantify adverse event rates, and identify predictive factors of long-term success. SUMMARY BACKGROUND DATA: Few studies have evaluated the long-term success of SNM. METHODS: Data collected prospectively from patients implanted for fecal incontinence (FI) in 7 French centers between January 1998 and December 2008 were retrospectively analyzed. Patient FI severity scores were assessed before and 10 years after implantation. The main evaluation criterion was the success of SNM defined by the continuation of the treatment without additional therapies. The secondary evaluation criteria were the rate of device revisions and explantations. Preoperative predictors of success at 10 years were sought. RESULTS: Of the 360 patients (27 males, mean age: 59 ± 12 years) implanted for FI, 162 (45%) had a favorable outcome 10 years post-implantation, 115 (31.9%) failed, and 83 (23.1%) were lost to follow-up. The favorable outcome derived from the time-to-event Kaplan-Meier curve at 10 years was 0.64 (95% CI 0.58-0.69). FI severity scores were significantly better 10 years post-implantation compared to preimplantation (7.4 ± 4.3 vs 14.0 ± 3.2; P < 0.0001). During the 10-year follow-up, 233 patients (64.7%) had a surgical revision and 94 (26.1%) were explanted. A history of surgery for FI and sex (male) were associated with an increased risk of an unfavorable outcome. CONCLUSIONS: Long-term efficacy was maintained in approximately half of the FI patients treated by SNM at least 10 years post-implantation.

European Society of Coloproctology guidance on the use of mesh in the pelvis in colorectal surgery.

This is a comprehensive and rigorous review of currently available data on the use of mesh in the pelvis in colorectal surgery. This guideline outlines the limitations of available data and the challenges of interpretation, followed by best possible recommendations.

Practical issues encountered while determining Minimal Clinically Important Difference in Patient-Reported Outcomes.

BACKGROUND: Using a real dataset, we highlighted several major methodological issues raised by the estimation of the Minimal Clinically Important Difference (MCID) of a Patient-Reported Outcomes instrument. We especially considered the management of missing data and the use of more than two times of measurement. While inappropriate missing data management and inappropriate use of multiple time points can lead to loss of precision and/or bias in MCID estimation, these issues are almost never dealt with and require cautious considerations in the context of MCID estimation. METHODS: We used the LIGALONGO study (French Randomized Controlled Trial). We estimated MCID on the SF-36 General Health score by comparing many methods (distribution or anchor-based). Different techniques for imputation of missing data were performed (simple and multiple imputations). We also consider all measurement occasions by longitudinal modeling, and the dependence of the score difference on baseline. RESULTS: Three hundred ninety-three patients were studied. With distribution-based methods, a great variability in MCID was observed (from 3 to 26 points for improvement). Only 0.2 SD and 1/3 SD distribution methods gave MCID values consistent with anchor-based methods (from 4 to 7 points for improvement). The choice of missing data imputation technique clearly had an impact on MCID estimates. Simple imputation by mean score seemed to lead to out-of-range estimate, but as missing not at random mechanism can be hypothesized, even multiple imputations techniques can have led to an slight underestimation of MCID. Using 3 measurement occasions for improvement led to an increase in precision but lowered estimates. CONCLUSION: This practical example illustrates the substantial impact of some methodological issues that are usually never dealt with for MCID estimation. Simulation studies are needed to investigate those issues. TRIAL REGISTRATION: NCT01240772 (ClinicalTrials.gov) registered on November 15, 2010.

Functional Results and Quality of Life Following Magnetic Anal Sphincter Augmentation in Severely Incontinent Patients.

OBJECTIVE: Magnetic anal sphincter augmentation is a novel surgical option in the treatment of severe fecal incontinence. This study aimed to analyze functional results, quality of life, and satisfaction after implantation in the mid-term, and to identify factors associated with success of this new treatment. METHODS: All patients, who underwent magnetic anal sphincter augmentation procedure at a single center between December 2008 and January 2016, were consecutively included. Symptom severity [Cleveland Clinic Incontinence Score (CCIS)], quality of life [Fecal-Incontinence Quality of Life Questionnaire (FIQL)], bowel diary data, and patients' satisfaction were assessed before and after implantation. RESULTS: Forty-five patients (43 female), mean (s.d.) age 66.82 (±10.07), were followed for a median of 36 months (range 6-84). Two patients were explanted and 1 lost to follow-up. On a 3-week diary, major leakage rate significantly improved as did CCIS and FIQL. No significant difference was seen for flatus and minor leaks. Postoperative decrease of CCIS by ≥5.5 points correlated best with satisfaction, expressed by 22 patients (48% in intention-to-treat analysis). An independent predictive factor for success after implantation was no previous fecal incontinence surgical treatment. CONCLUSIONS: Satisfaction, functional, and quality of life outcomes improve significantly following magnetic anal sphincter augmentation.

Long-term Outcome of Hirschsprung Disease: Impact on Quality of Life and Social Condition at Adult Age.

BACKGROUND: Hirschsprung disease is a rare congenital disease typically requiring surgical treatment during childhood. Quality of life and social condition at adult age can be impaired by disease-specific sequelae. OBJECTIVE: This study aimed to assess the quality of life and social outcome of adult patients operated on for Hirschsprung disease during childhood. DESIGN: Patients operated on for Hirschsprung disease during childhood were identified and specific questionnaires were sent to them. SETTINGS: Data from 2 referral centers were used. PATIENTS: Patients who completed the questionnaires regarding quality of life and social condition were included. MAIN OUTCOME MEASURES: The Hirschsprung's Disease and Anorectal Malformations Quality of Life disease-specific questionnaire (8 dimensions explored; each scored from 0 to 100 maximum score) and a sociodemographic questionnaire were sent to identified patients. Sociodemographic data were compared with those of the French general population. RESULTS: Thirty-four patients had Hirschsprung disease (men, 76%; mean age, 32 years) were included in the study. Mean total Hirschsprung's Disease and Anorectal Malformations Quality of Life score was 611 of 800 (maximum score 800). The 2 most impaired dimensions were "physical symptoms" and "diarrhea" (62.9/100 and 73.6/100). Fecal continence was only marginally affected (mean score, 89/100). Patients with Hirschsprung disease achieved better educational levels than the French general population. Parental and marital status did not differ between the 2 groups. LIMITATIONS: This study had the limitations inherent to a retrospective study. CONCLUSION: The quality of life of adult patients with Hirschsprung disease sequelae is marginally impaired in this study. Despite the consequences of this congenital abnormality, the condition eventually achieved can be considered as satisfactory. See Video Abstract at http://links.lww.com/DCR/A917.

Is Sacral Nerve Modulation a Good Option for Fecal Incontinence in Men?

OBJECTIVE: The objective was to assess the efficacy and the safety of sacral nerve modulation (SNM) in men with fecal incontinence (FI) compared with those of SNM in women. METHOD: Prospectively collected data from patients from seven tertiary colorectal units who underwent an implant procedure between January 2010 and December 2015 were reviewed retrospectively. Outcomes and surgical revision and definitive explantation rates were compared between men and women. RESULTS: A total of 469 patients (60 men [12.8%]; mean age = 61.4 ± 12.0 years) were included in the study, 352 (78.1%) (31 men [8.8%]) of whom received a permanent implant. The ratio of implanted/tested men was significantly lower than the ratio of implanted/tested women (p = 0.0004). After a mean follow-up of 3.4 ± 1.9 years, the cumulative successful treatment rates tended to be less favorable in men than in women (p = 0.0514): 88.6% (75.6-95.1), 75.9% (60.9-86.4), 63.9% (48.0-77.3), and 43.9% (26.7-62.7) at one, two, three, and five years, respectively, in men; 92.0% (89.1-94.2), 84.2% (80.3-87.4), 76.8% (72.3-80.7), and 63.6% (57.5-69.3) at one, two, three, and five years, respectively, in women. The revision rate for infection and the definitive explantation rate for infection were higher in men than in women (p = 0.0001 and p = 0.0024, respectively). CONCLUSION: Both short- and long-term success rates of SNM for FI were lower in men than in women. The revision and definitive explantation for long-term infection rates were significantly higher in men.

Long-Term Outcome Following Implanted Pulse Generator Change in Patients Treated With Sacral Nerve Modulation for Fecal Incontinence.

BACKGROUND: Long-term outcome of sacral nerve modulation (SNM) patients after implanted pulse generator (IPG) change for fecal incontinence (FI) is unknown. This study reported the outcome and long-term satisfaction after a change of an exhausted IPG, questioning the need to concurrently change the electrode and looking for factors involved in the maintenance of treatment efficiency. METHODS: Patients with fecal incontinence and with a Medtronic IPG implanted in a single center (2001-2016) were prospectively followed up. Satisfaction was graded according to a patient-reported outcome measure from 0 to 10. A pre- and postreplacement FI severity score (Cleveland Clinic Fecal Incontinence Score) and Fecal Incontinence Quality of Life questionnaire were also collected. RESULTS: In 170 patients with SNM, 39 had an IPG replacement. At a median of 29 month after replacement, 32 and 7 patients reported respectively a similar and reduced satisfaction (7.6 ± 1.62 vs. 5.5 ± 0.87), p < .001. Satisfied patients were younger (65 years vs. 76 years, p < .001). Cleveland Clinic Fecal Incontinence Scores were not significantly different, but the satisfied group had a significantly better Fecal Incontinence Quality of Life score (p = .047). Only 5 patients needed an electrode change at the time of the IPG replacement or later. CONCLUSIONS: Patient satisfaction and efficiency remain high after IPG replacement. Older age has a negative impact on the outcome. Electrode replacement is rarely required and does not need to be performed routinely when an IPG is exhausted. CONFLICT OF INTEREST: Paul-Antoine Lehur has a consulting agreement with Medtronic SA. This had no impact with the results of the study. The other authors have no conflict of interests to declare.

Is the Failure of Laparoscopic Peritoneal Lavage Predictable in Hinchey III Diverticulitis Management?

BACKGROUND: Laparoscopic peritoneal lavage is an alternative to sigmoid resection in Hinchey III diverticulitis (generalized purulent peritonitis). The main limitation of laparoscopic peritoneal lavage is the higher rate of reoperation for persistent sepsis in comparison with sigmoid resection. OBJECTIVE: The purpose of the current study was to identify risk factors for laparoscopic peritoneal lavage failure in patients who have Hinchey III diverticulitis. DESIGN: This was a retrospective multicenter study. SETTINGS: The study was conducted in 3 clinical sites in France. PATIENTS: From 2006 to 2015, all consecutive patients undergoing emergent surgery for diverticulitis were reviewed. All patients operated on with laparoscopic peritoneal lavage for laparoscopically confirmed Hinchey III diverticulitis were included. MAIN OUTCOME MEASURES: The main outcome was laparoscopic peritoneal lavage failure, defined as reoperation or death at 30 postoperative days. RESULTS: A series of 71 patients (43 men, mean age 58 ± 15 years) were operated on with laparoscopic peritoneal lavage for Hinchey III diverticulitis. Laparoscopic peritoneal lavage failed in 14 (20%) of them: 1 died and 13 underwent reoperations. No major complication (Dindo-Clavien score ≥3) occurred after reoperation. Immunosuppressive drugs (p = 0.01) and ASA grade ≥3 (p = 0.02) were associated with laparoscopic peritoneal lavage failure after univariate analysis. Multivariate analysis identified only immunosuppressive drug intake (steroids or chemotherapy for cancer) as an independent predictive factor. Mean length of stay was 14.9 days (5-67). At the end of the 30 first postoperative days, 12 (17%) patients had a stoma. LIMITATIONS: The study was limited by its retrospective nature and the small size of the cohort. CONCLUSION: Our results highlight immunosuppressive drug intake as a major risk factor for laparoscopic peritoneal lavage failure in patients who have Hinchey III diverticulitis. Immunosuppression and severe comorbidities (ASA ≥3) should be considered when selecting a surgical option in patients with Hinchey III diverticulitis. See Video Abstract at http://links.lww.com/DCR/A423.

Sacral Nerve Stimulation for Fecal Incontinence: How Long Should the Test Phase Be?

BACKGROUND: Decision-making for pulse generator implantation for sacral nerve stimulation in the management of fecal incontinence is based on the results of a test phase. Its duration is still a matter of debate. OBJECTIVE: The purpose of this study was to determine whether an early positive response during the test phase could predict implantation of a permanent sacral nerve pulse generator. DESIGN: This was a short-term observational cohort study. A positive response was defined as a >50% decrease of fecal leaks compared with baseline. A multivariate logistic regression was computed to predict pulse generator implantation after the first week of the test phase. SETTINGS: The study was conducted in 3 national referral centers. PATIENTS: From January 2006 to December 2012, 144 patients with fecal incontinence enrolled in a prospectively maintained database completed a 2- to 3-week bowel diary, at baseline and during test phase. MAIN OUTCOME MEASURES: The primary outcome was the clinical decision to implant a pulse generator. The primary predictor was a calculated score including the number of leak episodes, bowel movements, and urgencies and the time to defer defecation expressed in minutes during the first screening test week. RESULTS: After the first, second and third week of the test phase, 81 (56%) of 144, 96 (67%) of 144, and 93 (70%) of 131 patients had a positive test. A permanent pulse generator was implanted in 114. Time to defer defecation increased during the 3 weeks of screening. Urgencies were unchanged. The computed score was predictive of a permanent pulse generator implantation (Se = 72.6% (95% CI, 59.8-83.1); Sp = 100% (95% CI, 78.2-100); c-index = 0.86 (95% CI, 0.78-0.94)). LIMITATIONS: No cost analysis or projection based on our proposal to reduce the test phase has been made. CONCLUSIONS: Permanent pulse generator implantation can be safely proposed early (1-week screening) to fast responders. Nonetheless, permanent implantation may be decided as well in patients exhibiting a delayed response. Whether a rapid response to sacral nerve stimulation could be predictive of a long-term response remains to be determined. See Video Abstract at http://links.lww.com/DCR/A452.

Long-term Experience of Magnetic Anal Sphincter Augmentation in Patients With Fecal Incontinence.

BACKGROUND: Magnetic anal sphincter augmentation is a novel technique for the treatment of patients with fecal incontinence. OBJECTIVE: The current study reports the long-term effectiveness and safety of this new treatment modality. DESIGN: This was a prospective multicenter pilot study. SETTINGS: The study was performed at 4 clinical sites in Europe and the United States. PATIENTS: The cohort included patients with severe fecal incontinence for ≥6 months who had previously failed conservative therapy and were implanted with a magnetic anal sphincter device between 2008 and 2011. MAIN OUTCOME MEASURES: Adverse events, symptom severity, quality of life, and bowel diary data were collected. RESULTS: A total of 35 patients (34 women) underwent magnetic anal sphincter augmentation. The median length of follow-up was 5.0 years (range, 0-5.6 years), with 23 patients completing assessment at 5 years. Eight patients underwent a subsequent operation (7 device explantations) because of device failure or complications, 7 of which occurred in the first year. Therapeutic success rates, with patients who underwent device explantation or stoma creation counted as treatment failures, were 63% at year 1, 66% at year 3 and 53% at year 5. In patients who retained their device, the number of incontinent episodes per week and Cleveland Clinic incontinence scores significantly decreased from baseline, and there were significant improvements in all 4 scales of the Fecal Incontinence Quality of Life instrument. There were 30 adverse events reported in 20 patients, most commonly defecatory dysfunction (20%), pain (14%), erosion (11%), and infection (11%). LIMITATIONS: This study does not allow for comparison between surgical treatments and involves a limited number of patients. CONCLUSIONS: Magnetic anal sphincter augmentation provided excellent outcomes in patients who retained a functioning device at long-term follow-up. Protocols to reduce early complications will be important to improve overall results.

How to Size the Anal Canal Circumference When Implanting a Magnetic Anal Sphincter for Fecal Incontinence. Evolution and Update of a New Surgical Technique.

INTRODUCTION: Magnetic anal sphincter augmentation improves function and quality of life of patients with severe fecal incontinence substantially. Measuring the anal circumference exactly with a sizing tool represents a crucial step of the procedure because it determines the correct size and success of the definite implant. OBJECTIVE: This study aims to illustrate the consequent development of 3 different sizing models and the use of the recent sizing tool. TECHNIQUE: After dissection of a tunnel around the anal canal through a ventral perineal incision, the sizing tool is inserted by using a specially designed introducer to measure the circumference for the appropriate size of implant. First- and second-generation sizing tools could only approximate the final implant size and impeded standardization. The latest sizing model resembles the actual implant with magnetic beads, it is nonstretchable, and it is closable end-to-end. RESULTS: The development of 3 measuring tools has progressively improved the accuracy of estimating the correct size of the definitive implant, and the application of the latest sizer seems easy, comfortable in use, and accurate as experienced in our first cases. CONCLUSION: The latest device contributes to standardization of the procedure and therefore facilitates the learning curve for newcomers of the method and could avoid the need for radiological on-table control in the near future.

Exhausted implanted pulse generator in sacral nerve stimulation for faecal incontinence: What next in daily practice for patients?

PURPOSE: The efficacy of sacral nerve stimulation in faecal incontinence relies on an implanted pulse generator known to have a limited lifespan. The long-term use of sacral nerve stimulation raises concerns about the true lifespan of generators. The aim of the study was to assess the lifespan of sacral nerve stimulation implanted pulse generators in daily practice, and the outcome of exhausted generator replacement, in faecal incontinent patients. METHODS: Faecal incontinent patients with pulse generators (Medtronic Interstim™ or InterstimII™) implanted in a single centre from 2001 to 2014 were prospectively followed up. Generator lifespan was measured according to the Kaplan-Meier method. Patients with a generator explanted/turned off before exhaustion were excluded. Morbidity of exhausted generator replacement and the outcome (Cleveland Clinic Florida Faecal Incontinence (CCF-FI) and Faecal Incontinence Quality of Life (FIQL) scores) were recorded. RESULTS: Of 135 patients with an implanted pulse generator, 112 (InterstimII 66) were included. Mean follow-up was 4.9 ± 2.8 years. The generator reached exhaustion in 29 (26%) cases. Overall median lifespan of an implanted pulse generator was approximately 9 years (95% CI 8-9.2). Interstim and InterstimII 25th percentile lifespan was 7.2 (CI 6.4-8.3) and 5 (CI 4-not reached) years, respectively. After exhaustion, generators were replaced, left in place or explanted in 23, 2 and 4 patients, respectively. Generator replacement was virtually uneventful. CCF-FI/FIQL scores remained unchanged after generator replacement (CCF-FI 8 ± 2 vs 7 ± 3; FIQL 3 ± 0.6 vs 3 ± 0.5; p = ns). CONCLUSION: In this study, the implanted pulse generator observed median lifespan was 9 years. After exhaustion, generators were safely and efficiently replaced. The study also gives insight into long-term needs and costs of sacral nerve stimulation (SNS) therapy.

Sacral nerve stimulation for faecal incontinence - efficacy confirmed from a two-centre prospectively maintained database.

INTRODUCTION: Sacral nerve stimulation (SNS) has been recognised as an effective treatment for faecal incontinence. Many unresolved questions could be answered when comparing large data-series from different centres providing prospective data. AIM: To present data, from an international two-centre SNS prospective database (SNSPD) on functional outcome and management of surgical complications in patients treated with SNS for faecal incontinence. METHOD: The SNSPD was designed in order to gather detailed pre- and perioperative information followed by a close follow-up in all patients undergoing SNS for bowel dysfunction. The SNSPD was open for inclusion of newly SNS implanted patients in May 2009, and closed on 31 December 2013. Two-centres Aarhus, Denmark, and Nantes, France, included and monitored all patients implanted due to bowel dysfunction according to database criteria. RESULTS: In total, 164 faecal incontinent patients with a median follow-up of 22 (range 1-50) months were implanted. The Wexner incontinence score improved from 15 (range, 3-20) at baseline to 9 (range, 0-20) at latest follow-up (P < 0.001) and VAS impact on daily life improved from 85.5 (range, 3-100) to 20 (range, 0-100) (P < 0.001). Additional surgical intervention was required in 19.5 % during follow-up. Repositioning of the pacemaker due to pain or migration was the most common complication in 12.1 %. Infections leading to explantation occurred in 3.0 %.

Percutaneous endoscopic caecostomy for severe constipation in adults: feasibility, durability, functional and quality of life results at 1 year follow-up.

BACKGROUND: The percutaneous endoscopic ceacostomy (PEC) for antegrade colonic enemas (ACE) has recently been proposed as a less invasive alternative to the Malone procedure in chronic constipated patients. Although the feasibility and safety of this innovative approach has been demonstrated, its functional results remain unknown. The aim of this study was to evaluate constipation symptoms and quality of life 1 year after the PEC placement. METHOD: From Oct 2007 to Apr 2011, 21 severely constipated patients who required ACE were prospectively included. They underwent endoscopic placement of Chait caecostomy catheter (Cook Medical). Patients completed standardized questionnaires to assess constipation (KESS) and quality of life (GIQLI) scores pre PEC placement and at 1 year. Adverse events and caecostomy use data were also documented. RESULTS: The caecostomy catheter was successfully placed in 19 patients. Complications were all minor, including chronic wound pain (n = 9), serous leakage (n = 7), superficial wound infection (n = 2) and accidental catheter removal (n = 2). Chronic wound pain led to definitive catheter removal in 5 (26 %) patients. One patient died from unrelated cause before the end of the follow-up. At 1 year, 11 (61 %) of the alive patients still performed ACE. During the period of ACE administration, 14 (74 %) patients suspended use of laxatives and retrograde irrigations. Constipation and quality of life scores were available in 15 patients. Median KESS score improved from 25 (12-39) before PEC to 17 (6-34) 1 year after PEC (p < 0.05). Median GIQLI score increased from 69 (25-108) to 95 (48-119) (p < 0.05). CONCLUSION: PEC placement achieves satisfying functional and quality of life results, and allows approximately 3/4 of patients to suspend laxatives and retrograde enemas. Nevertheless, 1/4 of the patients ask for the PEC removal because of chronic wound pain. In order to improve long-term durability of the device, a better prevention of pain is required.

The artificial bowel sphincter: a single institution experience over a decade.

OBJECTIVE: A report on the long-term results of a consecutive series of patients implanted with the Acticon Neosphincter. METHOD: Data were reviewed from a prospective database. From May 1996 to Jan 2010, 52 patients (46 women), mean age 51.5 ± 14.8 years, with severe fecal incontinence for a mean of 10.6 ± 10.5 years, were implanted with 85 devices. All patients had failed conservative management, including 13 with unsuccessful prior surgical treatments. Indications for implantation were sphincter destruction (45), pudendal neuropathy (12), congenital malformation (7), and perineal colostomy (4). Preoperative assessment included anal endosonography, anorectal manometry, and electrophysiologic testing. Incontinence (Wexner) and Quality of Life scores were recorded prior to the procedure and at each follow-up visit, together with annual anal physiology assessments. Cumulative risks of device revision and explantation were evaluated using Kaplan-Meier survival curves. RESULTS: Mean follow-up was 64.3 ± 46.5 months (range, 2-169); 26 patients (50%) required revisions after a mean of 57.7 ± 35.0 months, with 73.1% due to a leaking cuff from a microperforation; 14 patients (26.9%) required definitive explantation after a mean of 14.6 ± 7.9 months, with the majority (42.9%) due to infection; and 9 patients were lost to follow-up. In 35 patients (67.3%) with an activated device, there were significant improvements in both median Wexner (P < 0.0001) and Quality-of-life scores (P = 0.0286). There was a significant difference between preoperative resting anal pressures and closed pressures at activation (P < 0.0001) and latest follow-up (P < 0.0001). CONCLUSION: With careful patient selection, meticulous surgical technique, and dedicated surveillance, favorable long-term results can be achieved with acceptable rates of revision and explantation.

Outcome and cost analysis of sacral nerve modulation for treating urinary and/or fecal incontinence.

BACKGROUND: Sacral nerve modulation (SNM) is an established treatment for urinary and fecal incontinence in patients for whom conservative management has failed. OBJECTIVE: This study assessed the outcome and cost analysis of SNM compared to alternative medical and surgical treatments. METHODS: Clinical outcome and cost-effectiveness analyses were performed in parallel with a prospective, multicenter cohort study that included 369 consecutive patients with urge urinary and/or fecal incontinence. The duration of follow-up was 24 months, and costs were estimated from the national health perspective. Cost-effectiveness outcomes were expressed as incremental costs per 50% of improved severity scores (incremental cost-effectiveness ratio). RESULTS: The SNM significantly improved the continence status (P < 0.005) and quality of life (P < 0.05) of patients with urge urinary and/or fecal incontinence compared to alternative treatments. The average cost of SNM for urge urinary incontinence was ∈8525 (95% confidence interval, ∈6686-∈10,364; P = 0.001) more for the first 2 years compared to alternative treatments. The corresponding increase in cost for subjects with fecal incontinence was ∈6581 (95% confidence interval, ∈2077-∈11,084; P = 0.006). When an improvement of more than 50% in the continence severity score was used as the unit of effectiveness, the incremental cost-effectiveness ratio for SNM was ∈94,204 and ∈185,160 at 24 months of follow-up for urinary and fecal incontinence, respectively. CONCLUSIONS: The SNM is a cost-effective treatment for urge urinary and/or fecal incontinence.

The magnetic anal sphincter versus the artificial bowel sphincter: a comparison of 2 treatments for fecal incontinence.

BACKGROUND: Fecal incontinence is a debilitating ailment, and surgery offers the only recourse for the patients in whom conservative treatment fails. OBJECTIVE: This study aims to report the first matched comparison between patients implanted with the magnetic anal sphincter and the artificial bowel sphincter. PATIENTS AND INTERVENTIONS: From December 2008 to June 2010, 10 female patients, median age 64.5 years (range, 42-76), with severe fecal incontinence for a median of 7.5 years (range, 1-40), were implanted with the magnetic anal sphincter. Ten female patients implanted with the artificial bowel sphincter were identified. Both groups were matched for age, etiology, duration of incontinence, and preoperative functional scores. MAIN OUTCOME MEASURES: Outcomes measures included length of hospitalization, complications, and changes in functional scores (anorectal physiology, incontinence, and quality of life). RESULTS: Patients with the magnetic anal sphincter had a shorter median operative time (62 vs 97.5 min, P = .0273), length of hospitalization(4.5 vs 10 days, P < .001), and follow-up duration (8 vs 22.5 mo, P = .0068), without a statistically significant difference in 30-day complications (4 vs 2, P = .628) and revision/explantation (1 vs 4, P = .830). Both groups achieved significant improvements in preoperative incontinence (P < .0002) and quality-of-life scores (P < .009). In a comparison of baseline resting anal pressures, patients with the artificial bowel sphincter had significantly higher pressures with the cuff inflated (P = .0082), and those with the magnetic anal sphincter had a significant increase as well (P = .0469). At the latest review, both groups had similar quality-of-life scores (P = .374); patients with the artificial bowel sphincter had higher (median) closed-cuff anal pressures compared with the anal resting pressure of those with a magnetic anal sphincter (89 vs 58.5 cmH2O, P = .0147), together with more constipation (4 vs 1, P = .830) and a trend toward better incontinence scores (P = .0625). LIMITATIONS: This was a nonrandomized study with small patient numbers. CONCLUSION: In the short term, the magnetic anal sphincter is as effective as the artificial bowel sphincter in restoring continence and quality of life.

Robotic versus laparoscopic rectopexy for complex rectocele: a prospective comparison of short-term outcomes.

PURPOSE: The role of robotic assistance in pelvic floor prolapse surgery is debatable. This study aims to report our early experience of robotic-assisted ventral mesh rectopexy in the treatment of complex rectocele and to compare this with the laparoscopic approach in terms of safety and short-term postoperative outcomes. METHODS: We analyzed a cohort of 63 consecutive patients operated on for complex rectocele from March 2008 to December 2009. A complex rectocele was defined as a rectocele that had one or more of the following features: larger than 3 cm in diameter, associated with an enterocele or internal rectal prolapse. The patients underwent either the robotic procedure or laparoscopic procedure, based only on the availability of the robotic system. Procedures involved either a single-mesh fixation for posterior-compartment prolapse (concurrent rectocele and enterocele) or a double-mesh fixation for a concurrent anterior compartment prolapse (with cystocele). A transvaginal tape was inserted at the same surgery in patients with urinary incontinence. RESULTS: All patients were female; 40 underwent the laparoscopic procedure and 23 underwent the robotic procedure. Both groups were similar in age (mean, 59 ± 13 vs 61 ± 11; P = .440), ASA status, and previous abdominal surgery, respectively. Patients undergoing the robotic procedure had a significantly higher body mass index (mean, 27 ± 4 vs 24 ± 4; P = .03), more frequent double-mesh implantation (17/23 vs 14/40; P = .003), and longer operative time (mean, 221 ± 39 min vs 162 ± 60 min; P = .0001). Patients undergoing a laparoscopic procedure had slightly more blood loss (mean, 45 ± 91mL vs 6 ± 23 mL, P = .05). The number of transvaginal-tape procedures performed (6/40 vs 3/23, P > .999), conversion rate (10% vs 5%; P = .747), and duration of hospitalization were similar (mean, 5 ± 2 d vs 5 ± 1.6 d; P = .872). There were no mortalities or recurrences at the 6-month postoperative review. CONCLUSION: In our experience, the robotic approach for the treatment of complex rectocele is as safe as the laparoscopic approach, with favorable short-term results.