Intrarectal injections of botulinum toxin versus placebo for the treatment of urge faecal incontinence in adults (FI-Toxin): a double-blind, multicentre, randomised, controlled phase 3 study.

BACKGROUND: Non-randomised studies assessing intrarectal botulinum toxin type A (BoNTA) injections for faecal incontinence are promising. We aimed to evaluate the efficacy of BoNTA for the treatment of faecal incontinence in a randomised study. METHODS: In this randomised, double-blind, placebo-controlled study, we included adult patients who had at least one urgency or faecal incontinence episode per week for at least 3 months and who had experienced a failure of conservative or surgical treatment from eight French specialist hospital units with the skills to manage patients with faecal incontinence. Patients were randomly assigned (1:1) by a central web form to receive intrarectal submucosal injections of either 200 units of BoNTA (Botox; Allergan, Irvine, CA, USA; BoNTA group) or an equivalent volume of saline (placebo group), stratified by Cleveland Clinic Severity scores (CCS score; ≥12 or <12). Patients, investigators, study site staff, and sponsor personnel were masked to treatment allocation up to the 6-month visit. The primary endpoint was the number of episodes of faecal incontinence and urgency per day assessed using 21-day patient bowel diaries 3 months after the treatment. The primary analysis was performed using a modified intention-to-treat (mITT) approach (ie, in all the randomised patients who had received a treatment) with adjustment for baseline faecal incontinence and urgency episodes. After the final data collection at 6 months after injections, patients were unmasked and offered the BoNTA treatment if they were in the placebo group (rescue therapy) without masking, with an additional 6 months of safety follow-up. This trial is registered with ClinicalTrials.gov, number NCT02414425. FINDINGS: Between Nov 25, 2015, and Nov 25, 2020, we randomly assigned 200 patients to receive either BoNTA (n=100) or placebo (n=100) injections. Due to withdrawals before the injections, 96 patients were included in the BoNTA group and 95 patients were included in the placebo group (mITT analysis). The mean number of faecal incontinence and urgency episodes per day in the BoNTA group decreased from 1·9 (SD 2·2) at baseline to 0·8 (1·8) at 3 months after the injections, and from 1·4 (1·1) to 1·0 (1·0) in the placebo group, with a baseline-adjusted mean group difference at 3 months estimated at -0·51 (95% CI -0·80 to -0·21, p=0·0008). No serious treatment-related adverse events were reported in the trial. The most frequently reported non-serious adverse event (treatment related or not) following the BoNTA or placebo injections was constipation (reported in 68 [40%] of 169 patients who received the BoNTA injections and 38 [40%] of 95 patients who received placebo injections). INTERPRETATION: BoNTA injections are an efficacious treatment for urge faecal incontinence. Further research will define the optimum selection criteria, dose, site of injection, re-injection frequency, and long-term results. FUNDING: General Direction of Healthcare (French Ministry of Health).

Interferential therapy for chronic constipation in adults: The CON-COUR randomizedcontrolled trial.

BACKGROUND: Chronic constipation (CC) is a frequent condition, and the first-line treatment includes dietary rules, the use of laxatives, and biofeedback for evacuation disorders. However, almost half of the patients are dissatisfied with their current treatment. We report the first double-blind randomized multicenter trial assessing the effectiveness of transabdominal electrical stimulation by interferential therapy (IFT) in the treatment of CC in adults. METHODS: A prospective, multicenter, randomized, double-blind, sham-controlled, parallel-group, phase 3 trial was conducted at 7 centers in France. The primary endpoint was 8-week efficacy as defined by the number of complete spontaneous bowel movements during the last 4 weeks of the 8-week stimulation period. Secondary endpoints included the evaluation of the effects of IFT on symptoms (Patient Assessment of Constipation Symptoms questionnair (PAC-SYM)), quality of life (QOL) (Patient Assessment of Constipation Quality of Life), Colonic transit time (CTT), anorectal manometry, and patient satisfaction. RESULTS: The proportion of 8-week responders was not significantly different between the two groups (73.2% in the IFT group vs. 67.1% in the sham group). After 8 weeks of stimulation, the mean overall PAC-SYM score and the mean reduction in the overall PAC-SYM score were significantly greater in the IFT group than in the sham group. No differences were observed concerning CTT, anorectal manometry, or patient satisfaction. CONCLUSIONS: Although the primary endpoint was not reached, IFT can significantly alleviate the symptoms and improve the QOL of CC patients. It can be assumed that new treatments require different modes of evaluation and that the assessment of patient-reported outcomes may become a priority among therapeutic targets of CC. Trial registration number NCT02381665.

Endoscopic Kehr's T-Tube Placement to Treat Persistent Large Gastro-cutaneous Fistula After One Anastomosis Gastric Bypass: Video Demonstration.

BACKGROUND: We aim to show the endoscopic placement of a T-tube to treat a persistent large gastro-cutaneous fistula after OAGB. METHODS: We present the case of a 46-year-old woman with BMI of 48 kg/m2, who underwent OAGB and was re-operated on the 2nd postoperative day (POD) for leakage. Washing and drainage of the abdominal cavity was performed, and no fistulous orifice was identified. An upper gastrointestinal (GI) endoscopy was performed at POD 20 for the persistence of leakage of 150 ml/day by the drain and a gastric fistulous orifice of 2 cm was detected. RESULTS: At POD 22, under general anesthesia, upper GI endoscopy was performed and a T-tube was placed in the fistulous orifice with a "rendez-vous" technique (as demonstrated in the Video), placing the T branch in the digestive lumen pressed against the wall and the long part of the T exiting at the cutaneous orifice. The T-tube was clamped after 3 days and the patient could be gradually re-fed. The patient was discharged 8 days after the procedure, with perfect clinical tolerance and no complications. The ablation of the tube one was performed on POD 84. No relapse occurred during a follow-up of 48 months. CONCLUSION: Persistent large gastro-cutaneous fistulas with an orifice bigger than 1 cm in diameter are difficult to manage. The endoscopic placement of a T-tube seems a useful option, which may facilitate the healing of the fistula. Further studies are needed to better define the role of this procedure.

Ten-year outcome of one-anastomosis gastric bypass with a biliopancreatic limb of 150 cm versus Roux-en-Y gastric bypass: a single-institution series of 940 patients.

BACKGROUND: Long-term outcomes of one-anastomosis gastric bypass (OAGB) need to be compared with those of Roux-en-Y gastric bypass (RYGB). OBJECTIVE: The present study evaluates the long-term outcomes at 10-year follow-up of OAGB with a biliopancreatic limb of 150 cm versus RYGB. SETTING: Private practice, France. METHODS: Data of patients who underwent OAGB or RYGB as primary or secondary procedures between 2010 and 2011 at a referral center were collected prospectively and analyzed retrospectively. RESULTS: A total of 940 patients underwent OAGB (n = 405) or RYGB (n = 535). Operative time was significantly shorter in the OAGB group. Postoperative morbidity occurred in 17.2% of patients after RYGB versus 8.1% after OAGB (P ≤ .0001). Patients in the RYGB group had a significantly higher rate of kinking of the jejuno-jejunal anastomosis, stenosis of the gastrojejunal anastomosis, and dysphagia for early ulcers. At long term, no differences were found in the rate of severe malnutrition. Cumulated morbidity was significantly higher after RYGB, with higher incidence of internal hernia, anastomotic ulcer, blind-loop syndrome, and hypoglycemia. Conversion to RYGB and laparoscopic exploration for chronic pain were more frequent after OAGB. Surgery for weight regain was significantly more frequent after RYGB. Patients in the OAGB group had significantly lower weight, body mass index, and greater percentage excess, and total weight losses at 120 months. No significant differences were detected in co-morbidity outcomes. CONCLUSION: After 10 years, both RYGB and OAGB are effective procedures. However, OAGB is associated with shorter operative times and better results in short- and long-term morbidity and weight loss outcomes.

Treatment of Persistent Large Gastrocutaneous Fistulas After Bariatric Surgery: Preliminary Experience with Endoscopic Kehr's T-Tube Placement.

PURPOSE: Post-bariatric surgery gastrocutaneous fistula is a chronic leak with an incidence of 1.7 to 4.0% and no standardized management. A large gastrocutaneous fistula (LGCF) is not indicated for treatment with pigtail drains. We aimed to evaluate results of a novel treatment using endoscopic Kehr's T-tube placement. METHODS: Only patients with a postoperative LGCF duration of > 10 days and a flow rate of > 50 cc by external drainage after revisional surgery for sepsis were included. Endoscopic placement of Kehr's T-tube was performed. Patients had been reoperated with wash and drainage for severe sepsis after initial bariatric surgery in which no fistula had been discovered. Patients not reoperated, or with a fistula requiring intraoperative Kehr's T-tube placement, or a pigtail drain were excluded. Primary outcomes were endoscopic characteristics and results (LGCF closure rate, Kehr T-tube retention time, etc.). RESULTS: The study group included 12 women, 2 men; body mass index 43.1 ± 4.5 kg/m2. Interventions were SG (7), RYGB (2), OAGB (4), and SADI-S (1). Endoscopic assessment was carried out after a mean of 33.2 ± 44.3 days after the bariatric procedure. The mean fistula orifice diameter was 2.0 ± 0.9 cm. Kehr's T-tube was positioned at a mean 51.5 ± 54.8 days after the bariatric procedure. T-tube tolerance was excellent. Mean additional days: hospitalization, 34.4 ± 27.0; T-tube retention, 86.4 ± 73.1; fistula healing, 139.9 ± 111.5, LGCF closure rate, 92.9%. COMPLICATIONS: 1 pulmonary embolism, 2 T-tube migrations,1 drain-path bleed, 1 skin abscess. No mortality. CONCLUSIONS: Endoscopic Kehr's T-tube placement was successful in closing persistent post-bariatric surgery LGCF in 92.9% of patients.

Multidisciplinary Management of Leaks After One-Anastomosis Gastric Bypass in a Single-Center Series of 2780 Consecutive Patients.

PURPOSE: Few data exist in the literature concerning leaks after one-anastomosis gastric bypass (OAGB). Our aim was to describe the incidence, presentation, and management of leaks after OAGB. SETTING: A private clinic in France. METHODS: Between May 2010 and December 2017, 2780 consecutive patients underwent OAGB. A retrospective chart review was performed on the 46 patients (1.7%) who experienced postoperative leaks. RESULTS: Leaks arose from the anastomosis in 6 cases (13%) and from the gastric pouch in 27 cases (59%), while the remaining 13 patients (28%) had leaks from an undetermined origin. Management followed a standardized algorithm taking into consideration the clinical situation and findings on an oral contrast computed tomography (CT) scan. All patients were treated by fasting, total parenteral nutrition, and antimicrobial therapy. Nine patients (20%) could be managed by medical treatment only, 13 patients (28%) underwent laparoscopic management (washout and drainage plus T-tube placement in 5 cases or conversion to Roux-en-Y gastric bypass (RYGB) in one case). The remaining 23 patients (50%) were managed by percutaneous drainage and/or endoscopy. No mortality was observed; the major morbidity rate was 20%. The median length of a hospital stay was 17 days (5-80). CONCLUSION: Management of leaks after OAGB depends on clinical conditions and presence, size, and location of an abscess and/or a fistula. If endoscopy and interventional radiology are available, reoperation can be avoided in most patients. In most leaks at the gastrojejunal anastomosis, inserting a T-tube in the leak orifice avoids the necessity for conversion to RYGB.

A comparison of surgical devices for grade II and III hemorrhoidal disease. Results from the LigaLongo Trial comparing transanal Doppler-guided hemorrhoidal artery ligation with mucopexy and circular stapled hemorrhoidopexy.

PURPOSE: Little is presently known on the impact of device type for Doppler-guided hemorrhoidal artery ligation/mucopexy (DGHAL) or circular stapled hemorrhoidopexy (CSH) when a surgical treatment is considered for hemorrhoidal disease (HD). In this study, we aimed to compare the outcome in terms of adverse events and recurrence rate, of patients included in the multicenter LigaLongo RCT ( ClinicalTrials.gov NCT01240772) according to the type of devices used. METHODS: In the DGHAL arm (N = 193), the procedure was done with transanal hemorrhoidal dearterialization (THD)™ (THD, Correggio, Italy) (104 patients) and with HAL-RAR™ (Agency for Medical Innovations (AMI) GmbH, Feldkirch, Austria) (89 patients). In the CSH arm (N = 184), procedure for prolapse and hemorrhoids (PPH)-03™ (Ethicon Endo-Surgery, Cincinnati OH) and hemorrhoidopexy and prolapse (HEM)™ (Covidien, Inc.) staplers were used in respectively 106 and 78 cases. Surgery-related morbidity at 90 postoperative days (POD) based on the Clavien-Dindo procedure-related complication score and clinical outcome in terms of recurrence and reoperation rate at 12 postoperative months (POM) was collected. RESULTS: Three hundred and seventy-seven patients were randomized according to HD grade. In the DGHAL arm, the number of ligations and mucopexies was higher in the AMI group (p < 0.0001); at 90 POD, the overall morbidity was similar between the two groups. In the CSH arm, donut sizes were similar; at 90 POD, the PPH group had a higher risk of postoperative grade 1 morbidity (anal urgency or incontinence) compared to the HEM group (p = 0.003). At 12 POM, no statistical difference was found between the two groups of each arm in terms of grade III recurrence or reoperation. CONCLUSION: Postoperative morbidity and outcome at 1 year were similar regardless of the type of devices used. These findings suggest that device type has little impact on HD treatment results. TRIAL REGISTRATION: clinicaltrials.gov -Identifier NCT01240772.

Outcomes of stapled transanal rectal resection vs. biofeedback for the treatment of outlet obstruction associated with rectal intussusception and rectocele: a multicenter, randomized, controlled trial.

PURPOSE: This study was designed to assess the safety and outcomes achieved with stapled transanal rectal resection vs. biofeedback training in obstructed defecation patients. METHODS: A total of 119 women patients who suffered from obstructed defecation with associated rectocele and rectal intussusception were randomized to stapled transanal rectal resection or biofeedback training. Stapled transanal rectal resection was performed by using two circular staplers to produce transanal full-thickness rectal resection. Primary outcome was symptoms of obstructed defecation resolution at 12 months; secondary outcomes included safety, change in quality of life score, and anatomic correction of rectocele and rectal intussusception. RESULTS: Fourteen percent (8/59) stapled transanal rectal resection and 50 percent (30/60) biofeedback training patients withdrew early. Eight (15 percent) patients treated with stapled transanal rectal resection and 1 (2 percent) biofeedback patient experienced adverse events. One serious adverse event (bleeding) occurred after stapled transanal rectal resection. Scores of obstructed defecation improved significantly in both groups as did quality of life (both P < 0.0001). Successful treatment was observed in 44 (81.5 percent) stapled transanal rectal resection vs. 13 (33.3 percent) evaluable biofeedback training patients (P < 0.0001). Functional benefit was observed early and remained stable during the study. CONCLUSIONS: In this controlled trial, stapled transanal rectal resection was well tolerated, was more effective than biofeedback training for the resolution of obstructed defecation symptoms, and improved quality of life, with minimal risk of impaired continence. Thus, stapled transanal rectal resection offers a new treatment alternative for obstructed defecation after failure of conservative measures including biofeedback training, a noninvasive approach.