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.

Organ preservation for clinical T2N0 distal rectal cancer using neoadjuvant chemoradiotherapy and local excision (ACOSOG Z6041): results of an open-label, single-arm, multi-institutional, phase 2 trial.

BACKGROUND: Local excision is an organ-preserving treatment alternative to transabdominal resection for patients with stage I rectal cancer. However, local excision alone is associated with a high risk of local recurrence and inferior survival compared with transabdominal rectal resection. We investigated the oncological and functional outcomes of neoadjuvant chemoradiotherapy and local excision for patients with stage T2N0 rectal cancer. METHODS: We did a multi-institutional, single-arm, open-label, non-randomised, phase 2 trial of patients with clinically staged T2N0 distal rectal cancer treated with neoadjuvant chemoradiotherapy at 26 American College of Surgeons Oncology Group institutions. Patients with clinical T2N0 rectal adenocarcinoma staged by endorectal ultrasound or endorectal coil MRI, measuring less than 4 cm in greatest diameter, involving less than 40% of the circumference of the rectum, located within 8 cm of the anal verge, and with an Eastern Cooperative Oncology Group performance status of at least 2 were included in the study. Neoadjuvant chemoradiotherapy consisted of capecitabine (original dose 825 mg/m(2) twice daily on days 1-14 and 22-35), oxaliplatin (50 mg/m(2) on weeks 1, 2, 4, and 5), and radiation (5 days a week at 1·8 Gy per day for 5 weeks to a dose of 45 Gy, followed by a boost of 9 Gy, for a total dose of 54 Gy) followed by local excision. Because of adverse events during chemoradiotherapy, the dose of capecitabine was reduced to 725 mg/m(2) twice-daily, 5 days per week, for 5 weeks, and the boost of radiation was reduced to 5·4 Gy, for a total dose of 50·4 Gy. The primary endpoint was 3-year disease-free survival for all eligible patients (intention-to-treat population) and for patients who completed chemotherapy and radiation, and had ypT0, ypT1, or ypT2 tumours, and negative resection margins (per-protocol group). This study is registered with ClinicalTrials.gov, number NCT00114231. FINDINGS: Between May 25, 2006, and Oct 22, 2009, 79 eligible patients were recruited to the trial and started neoadjuvant chemoradiotherapy. Two patients had no surgery and one had a total mesorectal excision. Four additional patients completed protocol treatment, but one had a positive margin and three had ypT3 tumours. Thus, the per-protocol population consisted of 72 patients. Median follow-up was 56 months (IQR 46-63) for all patients. The estimated 3-year disease-free survival for the intention-to-treat group was 88·2% (95% CI 81·3-95·8), and for the per-protocol group was 86·9% (79·3-95·3). Of 79 eligible patients, 23 (29%) had grade 3 gastrointestinal adverse events, 12 (15%) had grade 3-4 pain, and 12 (15%) had grade 3-4 haematological adverse events during chemoradiation. Of the 77 patients who had surgery, six (8%) had grade 3 pain, three (4%) had grade 3-4 haemorrhage, and three (4%) had gastrointestinal adverse events. INTERPRETATION: Although the observed 3-year disease free survival was not as high as anticipated, our data suggest that neoadjuvant chemoradiotherapy followed by local excision might be considered as an organ-preserving alternative in carefully selected patients with clinically staged T2N0 tumours who refuse, or are not candidates for, transabdominal resection. FUNDING: National Cancer Institute and Sanofi-Aventis.

Magnetic anal sphincter augmentation for the treatment of fecal incontinence: a preliminary report from a feasibility study.

BACKGROUND: Magnetic sphincter augmentation, a successful treatment of gastroesophageal reflux disease, has been applied to treat fecal incontinence. The purpose of this feasibility study was to understand the safety profile as well as the potential benefit of this new device when it is implanted in patients with fecal incontinence. METHODS: A magnetic anal sphincter device was surgically implanted in candidates with documented fecal incontinence of more than 2 episodes per week at 3 investigational centers in Europe and the United States following ethics/institutional review board approval. The magnetic anal sphincter device was placed around the anal canal via a single anterior incision. All data were collected prospectively. The primary outcome measure was the reduction of incontinent episodes based on a daily continence diary. RESULTS: To date 14 patients have been implanted with the device (all female; mean age, 62.8 y; range, 41-74 y) with a median follow-up of 6 months. There have been no intraoperative complications. Mean hospital stay was 3 days; range, 1 to 7 days. Adverse events were observed in 7 patients. Three patients are no longer implanted with a device; 2 devices were removed and one passed spontaneously following a separation at the suture connection. Five patients with 6-month follow-up demonstrated a mean reduction in the number of average weekly incontinence episodes from 7.2 to 0.7 (90.9%) and a mean reduction in Wexner Continence Score from 17.2 to 7.8 (54.7%). Compared with baseline, quality of life improved in all 4 domains of the fecal incontinence quality of life (FIQoL) scoring system. No patients have reported that their condition has worsened. Two patients at 1-year follow-up both reported perfect continence. CONCLUSION: This preliminary study describes the use of a new device to treat fecal incontinence. Compared with existing devices, implantation is simple and it requires no adjustments from the physician or patient once the device is implanted. Initial assessment with a small number of patients shows promising outcomes with a limited incidence of complications and good restoration of continence.

Postoperative outcomes of Bascom cleft lift for pilonidal disease: A single-center experience.

INTRODUCTION: Limited data exists regarding outcomes for the Bascom cleft lift procedure for pilonidal disease. METHODS: Single-center retrospective review of patients who underwent a Bascom cleft lift from 2013 to 2018. Univariate analysis was performed to determine associations between patient-specific characteristics and post-operative complications. Postoperative complications were categorized as major or minor. Multivariate analysis was performed to identify predictors of postoperative complications. RESULTS: 235 patients were included. Forty-five percent were obese and 24% were active smokers. Minor complications occurred in 34.5% (81); major complications occurred in 19.1% (45). The recurrence rate was 4.7% (11). Smoking was not associated with postoperative complications. Obesity was independently associated with higher rates of both minor (OR 2.6, p = 0.001) and major (OR 2.3, p = 0.001) complications. DISCUSSION: Wound complications are common after Bascom cleft lift. Obesity is an independent predictor of postoperative complications. Obese patients should be appropriately counseled regarding their increased risk prior to surgery.

A 12-Month Clinical Durability of Effectiveness and Safety Evaluation of a Vaginal Bowel Control System for the Nonsurgical Treatment of Fecal Incontinence.

OBJECTIVE: The aim of this study was to characterize clinical success, impact on quality of life, and durability up to 1 year in women with fecal incontinence (FI) responsive to an initial test period with a trial vaginal bowel control system. METHODS: This was a prospective open-label study in subjects with FI and successfully fit who underwent an initial 2-week trial period. Those achieving 50% or greater reduction in FI episodes were provided the long-term system. Primary outcome was success at 3 months defined as 50% or greater reduction in baseline FI episodes, also assessed at 6 and 12 months. Secondary outcomes included symptom impact measured with Fecal Incontinence Quality of Life scale, symptom severity by the St Mark's (Vaizey) questionnaire, Patient Global Impression of Improvement, and satisfaction. Adverse events were collected. Primary analysis was intention to treat (ITT). RESULTS: Seventy-three subjects with baseline mean of 14.1 ± 12.15 FI episodes over 2 weeks entered the treatment period. Success rate at 3 months was 72.6% (53/73, P < 0.0001); per-protocol, 84.1% (53/63, P < 0.0001). Significant improvement in all Fecal Incontinence Quality of Life subscales and St Mark's questionnaire meeting minimally important differences was noted. Satisfaction was 91.7%, 89.7%, and 94.4% at 3, 6, and 12 months, respectively; 77.4%, 77.6%, and 79.6% were very much/much better on the Patient Global Impression of Improvement at 3, 6, and 12 months, respectively. Most common adverse event was vaginal wall injury, with most adverse events (90/134, 67%) occurring during fitting period. CONCLUSIONS: In women with successful fitting and initial treatment response, durable efficacy was seen at 3, 6, and 12 months by objective and subjective measures, with favorable safety.

A preliminary evaluation of the TOPAS system for the treatment of fecal incontinence in women.

OBJECTIVES: The TOPAS AMS pelvic floor repair system is a self-fixating polypropylene mesh intended for use to reinforce soft tissues where weakness exists in the gynecological and gastroenterological anatomy. It is not available commercially in any country. This was a preliminary study conducted to obtain initial clinical experience with the TOPAS system for the treatment of fecal incontinence (FI) in women. METHODS: This was a prospective study conducted at 5 centers in the United States. Women with FI who failed 1 or more conservative therapies were candidates for the study. Fecal incontinence was assessed with a bowel diary, Cleveland Clinic incontinence scores (CCISs), and Fecal Incontinence Quality of Life (FIQOL) questionnaires, and patients were followed prospectively up to 24 months. Treatment success was defined as a reduction in number of FI episodes of 50% or more compared with baseline. RESULTS: A total of 29 women (mean age, 60.6 years) were implanted with the TOPAS system. Mean number of FI episodes per 14 days decreased from 6.9 at baseline to 3.5 at 24 months of follow-up, and the reduction was significant for the entire follow-up period compared with baseline (P < 0.001). A total of 55.6% of the subjects reported treatment success. The CCIS and FIQOL scores for all domains were significantly improved during the overall follow-up period compared with baseline (P < 0.001). The most common procedure and/or device-related adverse events were de novo urinary incontinence, including bladder spasms (n = 6), worsening FI (n = 2), and constipation (n = 2). No device-related erosions or extrusions were reported. CONCLUSIONS: Initial experience of the TOPAS system demonstrated a significant improvement in FI episodes, CCIS and FIQOL scores, and a benign safety profile. These results indicate that the TOPAS system has potential as a new therapeutic option for FI, but it needs to be confirmed in a larger study.

Routine leak testing in colorectal surgery in the Surgical Care and Outcomes Assessment Program.

OBJECTIVE: To evaluate the effect of routine anastomotic leak testing (performed to screen for leaks) vs selective testing (performed to evaluate for a suspected leak in a higher-risk or technically difficult anastomosis) on outcomes in colorectal surgery because the value of provocative testing of colorectal anastomoses as a quality improvement metric has yet to be determined. DESIGN: Observational, prospectively designed cohort study. SETTING: Data from Washington state's Surgical Care and Outcomes Assessment Program (SCOAP). PATIENTS: Patients undergoing elective left-sided colon or rectal resections at 40 SCOAP hospitals from October 1, 2005, to December 31, 2009. INTERVENTIONS: Use of leak testing, distinguishing procedures that were performed at hospitals where leak testing was selective (<90% use) or routine (≥ 90% use) in a given calendar quarter. MAIN OUTCOME MEASURE: Adjusted odds ratio of a composite adverse event (CAE) (unplanned postoperative intervention and/or in-hospital death) at routine testing hospitals. RESULTS: Among 3449 patients (mean [SD] age, 58.8 [14.8] years; 55.0% women), the CAE rate was 5.5%. Provocative leak testing increased (from 56% in the starting quarter to 76% in quarter 16) and overall rates of CAE decreased (from 7.0% in the starting quarter to 4.6% in quarter 16; both P ≤ .01) over time. Among patients at hospitals that performed routine leak testing, we found a reduction of more than 75% in the adjusted risk of CAEs (odds ratio, 0.23; 95% CI, 0.05-0.99). CONCLUSION: Routine leak testing of left-sided colorectal anastomoses appears to be associated with a reduced rate of CAEs within the SCOAP network and meets many of the criteria of a worthwhile quality improvement metric.