The fecal incontinence quality of life scale (FIQL) and fecal incontinence severity index (FISI): Validation of the Dutch versions.

AIMS: Fecal incontinence (FI) is known to have a major impact on quality of life. The Fecal Incontinence Quality of Life scale (FIQL) and Fecal Incontinence Severity Index (FISI) have been developed to assess this impact. The aim of this study was to validate the FIQL and FISI in the Dutch language. METHODS: The study population consisted of women and men experiencing FI and a reference group. The FIQL (four domains) and FISI questionnaires were validated by testing standardized measurement properties: discriminative ability, internal consistency, reproducibility, construct validity, and responsiveness. RESULTS: A total of 55 patients and 277 reference participants were included. Patients had significant lower and higher scores at the FIQL and FISI, respectively, than references (FIQL: 2.58 ± 0.70 and 3.92 ± 0.36, FISI: 38.57 ± 10.73 and 23.17 ± 15.01; P < 0.001), indicating worse functioning in patients and with this the discriminative abilities of the measures. The FIQL demonstrated adequate internal consistency on all domains (0.72-0.96), except for the embarrassment domain (0.55). The reproducibility was good for both measures. A negative correlation was found between the FIQL and FISI. Furthermore, the FIQL showed a positive (0.77) and the FISI a negative correlation (-0.31) with the Mental Component Summary scale of the SF-12. Responsiveness analysis showed a minimal important change of 0.40 points for the FIQL. CONCLUSIONS: Validity and reliability were good in the Dutch FIQL, but inconclusive in the FISI. The Dutch FIQL can support physicians in determining the impact of FI on patient's quality of life. Neurourol. Urodynam. 36:710-715, 2017. © 2016 Wiley Periodicals, Inc.

Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial.

BACKGROUND: Incisional hernia is a frequent complication of midline laparotomy and is associated with high morbidity, decreased quality of life, and high costs. We aimed to compare the large bites suture technique with the small bites technique for fascial closure of midline laparotomy incisions. METHODS: We did this prospective, multicentre, double-blind, randomised controlled trial at surgical and gynaecological departments in ten hospitals in the Netherlands. Patients aged 18 years or older who were scheduled to undergo elective abdominal surgery with midline laparotomy were randomly assigned (1:1), via a computer-generated randomisation sequence, to receive small tissue bites of 5 mm every 5 mm or large bites of 1 cm every 1 cm. Randomisation was stratified by centre and between surgeons and residents with a minimisation procedure to ensure balanced allocation. Patients and study investigators were masked to group allocation. The primary outcome was the occurrence of incisional hernia; we postulated a reduced incidence in the small bites group. We analysed patients by intention to treat. This trial is registered at Clinicaltrials.gov, number NCT01132209 and with the Nederlands Trial Register, number NTR2052. FINDINGS: Between Oct 20, 2009, and March 12, 2012, we randomly assigned 560 patients to the large bites group (n=284) or the small bites group (n=276). Follow-up ended on Aug 30, 2013; 545 (97%) patients completed follow-up and were included in the primary outcome analysis. Patients in the small bites group had fascial closures sutured with more stitches than those in the large bites group (mean number of stitches 45 [SD 12] vs 25 [10]; p<0·0001), a higher ratio of suture length to wound length (5·0 [1·5] vs 4·3 [1·4]; p<0·0001) and a longer closure time (14 [6] vs 10 [4] min; p<0·0001). At 1 year follow-up, 57 (21%) of 277 patients in the large bites group and 35 (13%) of 268 patients in the small bites group had incisional hernia (p=0·0220, covariate adjusted odds ratio 0·52, 95% CI 0·31-0·87; p=0·0131). Rates of adverse events did not differ significantly between groups. INTERPRETATION: Our findings show that the small bites suture technique is more effective than the traditional large bites technique for prevention of incisional hernia in midline incisions and is not associated with a higher rate of adverse events. The small bites technique should become the standard closure technique for midline incisions. FUNDING: Erasmus University Medical Center and Ethicon.

Predictors of outcome after transanal advancement flap repair for high transsphincteric fistulas.

BACKGROUND: Transanal advancement flap repair fails in 1 of every 3 patients with a high transsphincteric fistula. It has been reported that smoking, obesity, and previous attempts at repair adversely affect the outcome of transanal advancement flap repair. Because these findings could not be confirmed by other studies, it is still unclear whether these and other factors have an impact on the outcome. OBJECTIVE: The aim of this study was to identify predictors of outcome in a large cohort of patients who underwent transanal advancement flap repair for a high transsphincteric fistula. DESIGN: This study was performed as a retrospective review. SETTINGS: The study was conducted at the Division of Colon and Rectal Surgery, Erasmus MC, between 2000 and 2012. PATIENTS: A consecutive series of 252 patients with a high transsphincteric fistula of cryptoglandular origin were included. Patients with a rectovaginal or Crohn fistula were excluded. INTERVENTIONS: All patients underwent transanal advancement flap repair. Preoperatively, patients underwent endoanal MRI. MAIN OUTCOME MEASURES: Healing was defined as complete wound healing with absence of symptoms. Patients were followed up to assess failure. Seventeen patient- and fistula-related variables were assessed. RESULTS: Median duration of follow-up was 21 months (range, 6-136 months). The failure rate at 3 years was 41% (95% CI, 34-48). None of the studied variables predicted the outcome of flap repair except horseshoe extension. In univariate and multivariate analyses, significantly less failures were observed in patients with a horseshoe extension (p < 0.05). LIMITATIONS: Retrospective design, a single surgeon series, and potential selection bias caused by the tertiary referral center status are the limitations of this study. CONCLUSIONS: Of all studied variables, horseshoe extension was found to be the only positive predictor of outcome after flap repair for high transsphincteric fistulas.

Treatment of anal fistulas with high intersphincteric extension.

BACKGROUND: Intersphincteric fistulas with a high upward extension, up to or above the level of the puborectal muscle, in the intersphincteric plane are rare. Most of these fistulas have no external opening and they are frequently associated with a high intersphincteric and/or supralevator abscess. Division of a large amount of internal anal sphincter by extended fistulotomy has a potential risk of diminished fecal continence. OBJECTIVE: The aim of this study was to evaluate flap repair combined with drainage of associated abscesses in high intersphincteric fistulas. DESIGN: This study was performed as a retrospective review. SETTINGS: The study was conducted at the Division of Colon and Rectal Surgery, Erasmus MC, between March 1995 and February 2011. PATIENTS: Fourteen patients with a cryptoglandular fistula with high intersphincteric extension were included. INTERVENTIONS: Transanal advancement flap repair combined with intersphincteric and/or extrasphincteric drainage of associated abscesses was performed. Preoperatively, patients underwent endoanal MRI. MAIN OUTCOME MEASURES: Healing was defined as complete wound healing with absence of symptoms. Patients were followed up to assess the recurrence rate and Rockwood fecal continence score. RESULTS: In 1 patient the fistula was not associated with an abscess. In 10 patients the fistula tract ended in a high intersphincteric abscess. Three patients presented with a high intersphincteric abscess and a supralevator abscess. Primary healing was observed in 79% of the patients. The 3 patients without primary healing had a supralevator abscess. In these patients, healing was obtained after a second, third, and fourth procedure. The overall healing rate was 100%. Median postoperative Rockwood score was 0 (range, 0-15). LIMITATIONS: Retrospective design and lack of baseline continence data were the limitations of this study. CONCLUSIONS: Since most high intersphincteric fistulas have no external opening and are frequently associated with abscesses, preoperative imaging is useful. Flap repair with adequate drainage of the abscesses is successful, except in fistulas with supralevator extension. However, healing may be achieved by additional procedures.

A multicenter randomized controlled trial evaluating the effect of small stitches on the incidence of incisional hernia in midline incisions.

BACKGROUND: The median laparotomy is frequently used by abdominal surgeons to gain rapid and wide access to the abdominal cavity with minimal damage to nerves, vascular structures and muscles of the abdominal wall. However, incisional hernia remains the most common complication after median laparotomy, with reported incidences varying between 2-20%. Recent clinical and experimental data showed a continuous suture technique with many small tissue bites in the aponeurosis only, is possibly more effective in the prevention of incisional hernia when compared to the common used large bite technique or mass closure. METHODS/DESIGN: The STITCH trial is a double-blinded multicenter randomized controlled trial designed to compare a standardized large bite technique with a standardized small bites technique. The main objective is to compare both suture techniques for incidence of incisional hernia after one year. Secondary outcomes will include postoperative complications, direct costs, indirect costs and quality of life. A total of 576 patients will be randomized between a standardized small bites or large bites technique. At least 10 departments of general surgery and two departments of oncological gynaecology will participate in this trial. Both techniques have a standardized amount of stitches per cm wound length and suture length wound length ratio's are calculated in each patient. Follow up will be at 1 month for wound infection and 1 year for incisional hernia. Ultrasound examinations will be performed at both time points to measure the distance between the rectus muscles (at 3 points) and to objectify presence or absence of incisional hernia. Patients, investigators and radiologists will be blinded during follow up, although the surgeon can not be blinded during the surgical procedure. CONCLUSION: The STITCH trial will provide level 1b evidence to support the preference for either a continuous suture technique with many small tissue bites in the aponeurosis only or for the commonly used large bites technique.