Long-term results of sacral neuromodulation for the treatment of anorectal diseases.

INTRODUCTION: Sacral neuromodulation (SNM) aims to improve anorectal function in patients with disorders of anal continence and rectal emptying. The mechanism of action of SNM is not well known, and its indications are still under evaluation. We report the functional results and morbidity of a prospective cohort treated between 2002 and 2019. RESULTS: A total of 284 patients (of 423 tested) had implantation of a SNM. Five patients (1.8%) were lost to follow-up. Among those who had implantation, the indications for SNM were anal incontinence (n=376), refractory constipation (n=17), anterior resection syndrome (n=13), solitary rectal ulcer syndrome (n=7), and chronic inflammatory bowel disease (IBD) (n=10). The morbidity rate was 2.7% (Dindo-Clavien>2), 33 patients (11%) required explantation for infection (n=5), pain (n=2), inefficacy (n=24) or other reasons (rectal cancer) (n=3). It was necessary to change the stimulator in 68 patients (24%) during the follow-up period. Regarding the group of patients with anal incontinence, functional results showed improvement of the incontinence score in 40% and of quality of life in 25% after a mean follow-up of 55months. CONCLUSION: SNM constitutes a mini-invasive treatment associated with low morbidity. Its' efficacy in anal incontinence makes it a priority approach. Other indications are still under evaluation; while results are promising, they are highly variable.

A search for new options to manage fecal incontinence.

Fecal incontinence (FI) is a highly prevalent condition known to substantially impair a patient's quality of life. Although a non-invasive treatment option, currently available anal plugs are poorly tolerated, not significantly effective and therefore not often used. We present a new disposable device based on an innovative concept that renews the interest for non-invasive "external" control of bowel content for FI patients. The Contix™ (Forconti Medical Ltd, Cesarea, Israel) permits creation of temporary "artificial" fecal impaction to avoid bowel leakage while inserted high into the "non sensitive" rectum where it is not felt by the patient and therefore tolerated for 6- to 12- hour use. This European conformity (CE)-marked device has a unique design that allows insertion, usage and removal in a similar manner to a vaginal pad. It comes in 2 parts: a flexible silicone-based oval-shaped biocompatible balloon and an applicator in which the balloon is folded for self-insertion. An external tube allows for the balloon to be inflated with 60-100ml. of air. In doing this, small smooth tines deploy on its surface to help maintain the balloon in place. A pulling string with a ring stays out of the anal canal to deflate and withdraw the balloon inverted on itself at end of use. Device handling that includes rectal insertion and withdrawal feasibility, wear time, comfort at the different steps of use, safety and of course effectiveness of Contix™ have been tested in small trials yet to be published but pilot studies support its uses at greater scale in expert centers in Europe and the United States. In summary the Contix™ is a non-invasive device for FI management based on an innovative concept. Initial results support its spread to identify its role as an ancillary service to existing approaches.

Obstructed defaecation syndrome: European consensus guidelines on the surgical management.

Clinical decision-making in the treatment of patients with obstructed defaecation remains controversial and no international guidelines have been provided so far. This study reports a consensus among European opinion leaders on the management of obstructed defaecation in different possible clinical scenarios.

Innovative appliance for colostomy patients: an interventional prospective pilot study.

BACKGROUND: The control of body waste emptying is a constant research topic in stoma care. The aim of this pilot study was to assess the efficacy and safety of an innovative colostomy appliance. METHODS: An interventional prospective non-comparative pilot study was conducted in seven French centers. The study device is a new type of two-piece appliance including a base plate and a "capsule cap" (CC) composed of a capsule cover and a folded collecting bag. The device gently seals the stoma to provide stoma output control. When the bowel movement pressure increases the patient may control the deployment of the folded bag and collect stools. Patients with left-sided colostomy all using a flat appliance, were enrolled in a 2-week trial. Outcome measures were type of CC removal and peristomal fecal leaks while wearing the device. RESULTS: Of 30 patients (females 66.7%), with left-sided colostomy (permanent 76.7%), 23 (76.7%) completed the 2-week trial. A total of 472 CC changes were analyzed. EFFICACY: of 404 (85.5%) CC changes reported in diaries, 302 (74.8%) were linked with stool and/or gas. In 244 (60.3%) changes, the patient controlled stoma bag deployment and it occurred with bowel emptying 301 (74.5%) times. No leaks around the appliance were observed in 400 (85.3%) changes. SAFETY: no serious adverse event occurred. Peristomal skin was not modified during the trial. CONCLUSIONS: In the short term this new device has provided an increased control over bowel emptying at no risk in half of the trial population suggesting that an alternative approach to bag wearing is achievable.

Sacral nerve modulation for faecal incontinence: influence of age on outcomes and complications. A multicentre study.

AIM: Faecal incontinence is frequent in the elderly. Little is currently known about the efficacy of sacral nerve modulation (SNM) in the elderly. The present study aimed to assess the impact of age on the outcome of SNM and on the surgical revision and explantation rates by comparing the results of a large data set of patients. METHOD: Prospectively collected data from patients who underwent an implant procedure between January 2010 and December 2015 in seven French centres were retrospectively evaluated. In total, 352 patients [321 women; median age (range): 63 (24-86) years] were included. Clinically favourable and unfavourable outcomes, and surgical revision and explantation rates, were compared according to the age of the patients. RESULTS: A similar outcome was observed when comparing patients < 70 years and ≥ 70 years (a favourable outcome in 79.2% and 76.2%, respectively, P = 0.89). The probability of a successful treatment as a function of time was similar for the two age groups (< 70 years and ≥ 70 years, P = 0.54). The explantation and revision rates were not influenced by age (explantation rate: 17% in patients < 70 years vs 14% in patients ≥ 70 years, P = 0.89; and revision rate: 42% in patients < 70 years vs 40% in patients ≥ 70 years, P = 0.89). The probability of explantation as a function of time was similar for the two age groups (P = 0.82). The limitations of this study were its retrospective status, the rate of loss at follow-up and different durations of patient follow-up. CONCLUSIONS: Our results suggest that patients ≥ 70 years suffering from faecal incontinence benefit from SNM with a similar risk as a younger population.

Bowel perforation in type IV vascular Ehlers-Danlos syndrome. A systematic review.

Spontaneous gastrointestinal (GI) perforation is a well-known complication occurring in patients suffering from Type IV vascular Ehlers-Danlos syndrome (EDS IV). The aim of the present study was to review the current literature on spontaneous GI perforation in EDS IV and illustrate the surgical management and outcome when possible. A systematic review of all the published data on EDS IV patients with spontaneous GI perforation between January 2000 and December 2015 was conducted using three major databases PUBMED, EMBASE, and Cochrane Central Register of Controlled Trails. References of the selected articles were screened to avoid missing main articles. Twenty-seven published case reports and four retrospective studies, including 31 and 527 cases, respectively, matched the search criteria. A case from our institution was added. Mean age was 26 years (range 6-64 years). The most frequent site of perforation was the colon, particularly the sigmoid, followed by small bowel, upper rectum, and finally stomach. The majority of cases were initially managed with Hartmann's procedure. In recurrent perforations, total colectomy was performed. The reperforation rate was considerably higher in the "partial colectomy with anastomosis" group than in the Hartmann group. Colonic perforation is the most common spontaneous GI perforation in EDS IV patients. An unexpected fragility of the tissues should raise the possibility of a connective tissue disorder and prompt further investigation with eventual management of these high-risk patients with a multidisciplinary team approach in dedicated centres. In the emergency setting, a Hartmann procedure should be performed.

Wound closure with Karydakis flap is decreasing the perioperative costs after pilonidal sinus excision as compared to lay-open approach.

PURPOSE: To assess the impact of a simple flap closing procedure by Karydakis flap (KF) after pilonidal sinus excision on the costs and healing time as compared to routine lay-open technique. METHOD: Out of 44 consecutive patients operated on for pilonidal excision (November 2013-March 2015), 17 had a Karydakis flap and 27 a lay-open procedure. For each patient, the length of stay, the operating time (OT), the time needed for complete healing and postoperative care resources were recorded. The global costs included OT, nursing care quantity, and modalities until complete scar healing. RESULTS: One reoperation in the lay-open group was necessary during the follow-up (8±5months). No recurrence occurred. Postoperative morbidity was similar in both groups. Results showed that KF global cost was inferior as compared to lay-open technique (941±178€ vs. 1601±399€; P=0.0001), KF healed faster (32±17 vs. 59±22days; P=0.0001), whereas OT was longer in KF group (16±7 vs. 25±4min; P=0.001). CONCLUSION: KF allows a faster healing time and a 41% lower cost than lay-open technique. Preferential use of KF rather than lay-open procedure could allow a significant health cost saving.

Randomized clinical trial of percutaneous tibial nerve stimulation versus sham electrical stimulation in patients with faecal incontinence.

BACKGROUND: The aim was to assess the effects of percutaneous tibial nerve stimulation (PTNS) in the treatment of faecal incontinence (FI) by means of an RCT. METHODS: Patients aged over 18 years with FI were included in a multicentre, single-blinded RCT. The primary endpoint was reduction in the median or mean number of FI episodes per week. Secondary endpoints were changes in measures of FI severity, and disease-specific and generic quality of life. Outcomes were compared between PTNS and sham stimulation after 9 weeks of treatment. RESULTS: A higher proportion of patients in the PTNS (13 of 29) than in the sham (6 of 30) group showed a reduction of at least 50 per cent in the median number of FI episodes/week (incidence rate ratio (IRR) 2·40, 95 per cent c.i. 1·10 to 5·24; P = 0·028), but not in the mean number of episodes/week (10 of 29 versus 8 of 30; IRR 1·42, 0·69 to 2·92; P = 0·347). The absolute median number of FI episodes per week decreased in the PTNS but not in the sham group (IRR 0·66, 0·44 to 0·98; P = 0·041), as did the mean number (IRR 0·65 (0·45 to 0·97); P = 0·034). Scores on the Cleveland Clinic Florida faecal incontinence scale decreased significantly in both groups, but more steeply in the PTNS group (mean difference -1·3, 95 per cent c.i. -2·6 to 0·0; P = 0·049). The aggregated mental component score of Short Form 36 improved in the PTNS but not in the sham group (mean difference 5·1, 0·5 to 9·6; P = 0·028). CONCLUSION: PTNS may offer a small advantage in the clinical management of FI that is insufficiently responsive to conservative treatment. The key challenge will be to identify patients who may benefit most from this minimally invasive surgical procedure. Registration number: NCT00974909 (http://www.clinicaltrials.gov).

Randomized clinical trial of sacral nerve stimulation for refractory constipation.

BACKGROUND: Open studies have reported favourable results for sacral nerve stimulation in the treatment of refractory constipation. Here, its efficacy was assessed in a double-blind crossover RCT. METHODS: Patients with at least two of the following criteria were included: fewer than three bowel movements per week; straining to evacuate on more than 25 per cent of attempts; or sensation of incomplete evacuation on more than 25 per cent of occasions. Response to therapy was defined as at least three bowel movements per week and/or more than 50 per cent improvement in symptoms. Responders to an initial 3-week peripheral nerve evaluation were offered permanent implantation of a pulse generator and were assigned randomly in a crossover design to two 8-week intervals of active or sham stimulation. At the end of the two trial periods, the patients received active stimulation until the final evaluation at 1 year. RESULTS: Thirty-six patients (34 women; mean(s.d.) age 45(14) years) underwent peripheral nerve evaluation. Twenty responded and received a permanent stimulator. A positive response was observed in 12 of 20 and 11 of 20 patients after active and sham stimulation periods respectively (P = 0·746). Pain related to the device occurred in five patients and wound infection or haematoma in three, leading to definitive removal of the pulse generator in two patients. At 1 year, 11 of the 20 patients with an implanted device continued to respond. Stimulation had no significant effect on colonic transit time. CONCLUSION: These results do not support the recommendation of permanent implantation of a pulse generator in patients with refractory constipation who initially responded to temporary nerve stimulation. Registration number: NCT01629303 (http://www.clinicaltrials.gov).

Internal rectal prolapse: Definition, assessment and management in 2016.

Internal rectal prolapse (IRP) is a well-recognized pelvic floor disorder mainly seen during defecatory straining. The symptomatic expression of IRP is complex, encompassing fecal continence (56%) and/or evacuation disorders (85%). IRP cannot be characterized easily by clinical examination alone and the emergence of dynamic defecography (especially MRI) has allowed a better comprehension of its pathophysiology and led to the proposition of a severity score (Oxford score) that can guide management. Decision for surgical management should be multidisciplinary, discussed after a complete work-up, and only after medical treatment has failed. Information should be provided to the patient, outlining the goals of treatment, the potential complications and results. Stapled trans-anal rectal resection (STARR) has been considered as the gold standard for IRP treatment. However, inconsistent results (failure observed in up to 20% of cases, and fecal incontinence occurring in up to 25% of patients at one year) have led to a decrease in its indications. Laparoscopic ventral mesh rectopexy has substantial advantages in solving the functional problems due to IRP (efficacy on evacuation and resolution of continence symptoms in 65-92%, and 73-97% of patients, respectively) and is currently considered as the gold standard therapy for IRP once the decision to operate has been made.

Carcinoma arising in enteric diversion or rectal neobladder for bladder exstrophy.

Bladder exstrophy is a rare malformation. Ureteral diversion, such as ureterosigmoidostomy or a neorectal bladder, has been described. When the patients reach adulthood, cancer may arise in these reconstructions. Our aim was to perform a systematic review (all languages) of the published literature on neoplasia after urinary diversion and suggested management in cases of cancer. PubMed and Cochrane library were searched for relevant articles published within the last 20 years. All identified articles were reviewed for inclusion. Carcinoma occurring in the bladder and unreconstructed exstrophy were excluded. Out of 47 articles found, 12 matched our search criteria. The outcomes of 23 patients (including 2 from the authors' institution) were reported. Twenty-two patients with adenocarcinoma and 1 with carcinoid tumour were identified. Median age at urinary diversion was 3 (range 1-13) years. There were 20 ureterosigmoidostomies and 2 neorectal bladders. Cancer was diagnosed subsequently at a median of 31 (range 5-55) years after urinary diversion still in place (n = 18) or 21 years (range 1-30) after incomplete excision of ureteric stump when re-diverted (n = 5). The long-term outcomes of 15 patients were available. Ten died due to colorectal adenocarcinoma, and 5 were disease-free at 3 years. Patients with enteric diversion for bladder exstrophy, including those with subsequent reconstruction, are at risk of adenocarcinoma during adulthood. It is important to provide adequate surveillance. If lesions suggestive of carcinoma are seen, complete excision of the receptive bowel and urinary diversion are mandatory.

Is the efficacy of sacral nerve stimulation for faecal incontinence dependent on the number of active electrode poles achieved during permanent lead insertion?

AIM: Sacral nerve stimulation (SNS) is effective for faecal incontinence (FI). Little is known about the relationship between the implantation technique and the functional outcome. This study aimed to explore the relationship between the numbers of active electrode poles (AEP) achieved during permanent lead placement and subsequent function, therapeutic amplitude and the need for extra appointments between scheduled follow-up visits. METHOD: One hundred and eighty-six patients with FI who underwent permanent implantation between May 2009 and March 2015 with a tined (barbed) lead (3093/3080, Medtronic) using the straight stylet were registered on the European two-centre SNS prospective database (SNSPD). Correlation between the number of AEP, function, stimulation amplitude and the need for extra visits was analysed. RESULTS: The numbers of patients having an intra-operative motor response on stimulation of one, two, three and four poles were 18 (9.7%), 75 (40.3%), 61 (32.8%) and 32 (17.2%). The Wexner incontinence score was significantly reduced from 15 (±2.8) at baseline to 9.2 (±4.8) at the latest follow-up after a mean 878 ± 561 days (SD; P < 0.001). No correlation was found between the number of AEP and the functional outcome (P > 0.05). Patients with four-AEP had a reduced therapeutic amplitude up to 289 (±146) days of follow-up (P < 0.03). The number of AEP did not influence the need for extra follow-up visits (P < 0.223). CONCLUSION: The functional outcome and number of extra visits after SNS for FI did not depend on the number of AEP achieved. The therapeutic amplitude was reduced during the first postoperative year if four AEP were achieved during lead placement.

Current surgical treatment of obstructed defecation among selected European opinion leaders in pelvic floor surgery.

BACKGROUND: The aim of this study was to perform a survey on the surgical management of obstructed defecation (OD) across advocated selected coloproctological experts across Europe. METHODS: Surgeons from 42 centers of coloproctology in Europe were asked to complete a questionnaire, including seven questions about their past and present operative treatment strategy for patients with OD. RESULTS: The questionnaire was completed by 32 experts of pelvic floor surgery in 13 European countries. All but one indicated that they consider surgical treatment for OD. Seventy-four percent of these have been using transanal stapled rectal resection (STARR) and 96 % transabdominal rectopexy. While only 65 %, who have begun performing STARR are still using transanal resection, the technique is still being used by all surgeons performing abdominal procedures. Rectopexy only, STARR only, or both approaches are offered by 52, 3, and 45 % of surgeons, respectively. CONCLUSIONS: The use of STARR in the treatment of OD is decreasing among European opinion leaders in the field of pelvic floor surgery, while the application of transabdominal procedures continues.

Sacral nerve stimulation for faecal incontinence and constipation: a European consensus statement.

AIM: In Europe during the last decade sacral nerve stimulation (SNS) or sacral neuromodulation (SNM) has been used to treat faecal incontinence (FI) and constipation. Despite this, there is little consensus on baseline investigations, patient selection and operative technique. A modified Delphi process was conducted to seek consensus on the current practice of SNS/SNM for FI and constipation. METHOD: A systematic literature search of SNS for FI and constipation was conducted using PubMed. A set of questions derived from the search and expert opinion were answered on-line on two occasions by an international panel of specialists from Europe. A 1-day face-to-face meeting of the experts finalized the discussion. RESULTS: Three hundred and ninety-three articles were identified from the literature search, of which 147 fulfilled the inclusion criteria. Twenty-two specialists in FI and constipation from Europe participated. Agreement was achieved on 43 (86%) of 50 domains including the set-up of service, patient selection, baseline investigations, operative technique and programming of the device. The median of agreement was 95% (35-100%). CONCLUSION: Consensus was achieved on the majority of domains of SNS/SNM for FI and constipation. This should serve as a benchmark for safe and quality practice of SNS/SNM in Europe.

Relief of obstructed defecation syndrome after stapled transanal rectal resection (STARR): a meta-analysis.

OBJECTIVES: Stapled transanal rectal resection (STARR) is a promising new treatment for obstructed defecation syndrome (ODS) associated with rectal intussusception and/or rectocele. The aim of this work was to assess the efficacy of STARR to treat ODS. METHODS: Outcome data after STARR for ODS were pooled according to the used constipation score. As different types of constipation scores were reported, and standardized effect sizes were calculated before performing a meta-analysis. RESULTS: Twenty-six publications were identified with a median follow-up of 12 months (range: 3-42). In total 1298 patients were included. Six different scoring systems were used. In total 43 estimates of the effect STARR were analyzed. All studies showed a significant improvement in ODS yielding a combined standardized effect size of 3.8 (95% CI : 3.2-4.5). Although a very high degree of heterogeneity between effect sizes has been observed (I2 = 93.3%), suggesting an overestimation of this improvement. This is partially due to the use of various instruments, but largely originating from (unmeasured) study characteristics. CONCLUSIONS: The consistent finding of a decrease in the various ODS-scores confirms that STARR can reduce ODS but the effect is overestimated. This meta-analysis clearly highlights some methodological shortcomings in published data. Heterogeneity in ODS scoring implies the need for standard effect size calculation to compare published results, and underlines the urgent need for a more uniform and accurate data reporting.

Percutaneous tibial nerve stimulation vs sacral nerve stimulation for faecal incontinence: a comparative case-matched study.

AIM: The study assessed the initial experience with posterior tibial nerve stimulation (PTNS) for faecal incontinence and compared it with sacral nerve stimulation (SNS) performed in a single centre during the same timespan. METHOD: A retrospective review of a prospectively collected database was conducted at the colorectal unit, University Hospital, Nantes, France, from May 2009 to December 2010. Seventy-eight patients diagnosed with chronic severe faecal incontinence underwent neurostimulation including PTNS in 21 and SNS in 57. The main outcome measures were faecal incontinence (Wexner score) and quality of life (Fecal Incontinence Quality of Life, FIQL) scores in a short-term follow-up. RESULTS: No significant differences were observed in patients' characteristics. Of 57 patients having SNS, 18 (32%) failed peripheral nerve evaluation and 39 (68%) received a permanent implant. Two (5%) developed a wound infection. No adverse effects were recorded in the PTNS group. There was no significant difference in the mean Wexner and FIQL scores between patients having PTNS and SNS at 6 (P = 0.39 and 0.09) and 12 months (P = 0.79 and 0.37). A 50% or more improvement in Wexner score was seen at 6 and 12 months in 47% and 30% of PTNS patients and in 50% and 58% of SNS patients with no significant difference between the groups. CONCLUSION: Posterior tibial nerve stimulation is a valid method of treating faecal incontinence in the short term when conservative treatment has failed. It is easier, simpler, cheaper and less invasive than SNS with a similar short-term outcome.