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Video-assisted anal fistula treatment versus fistulectomy and sphincter repair in the treatment of high cryptoglandular anal fistula: a randomized clinical study.

ABSTRACT: Video-assisted anal fistula treatment (VAAFT) may have a recurrence rate comparable to that of fistulectomy and sphincter repair (FSR) in the treatment of high anal fistula and with potential advantages in wound healing, functional outcome and quality of life. The aim and objectives of the study are to compare the outcome of VAAFT with that of FSR for high cryptoglandular anal fistula. This was a single-centre randomized controlled trial of adults with high anal fistula comparing FSR with VAAFT. Primary outcome was fistula recurrence. Secondary outcomes were results of anal manometry, quality of life and faecal continence. A power calculation of 33 patients in each arm (1 : 1) was based on recurrence in the FSR and VAAFT groups of 5 per cent and 30 per cent respectively. Follow-up at 6 months after surgery included physical examination, MRI, anal manometry, quality-of-life assessment (RAND SF 36 questionnaire) and faecal-continence assessment (Wexner score). The study was terminated early due to high recurrence rates in both groups. A total of 45 patients were included. Recurrence rates were 65 per cent for VAAFT and 27 per cent for FSR, with hazard ratio 4.18 (P = 0.016). Length of the fistula was a risk factor with an association with recurrence (hazard ratio 1.8, P = 0.020). There were significant differences in quality of life in favour of FSR and in anal manometry in favour of VAAFT with a significant improvement in Wexner score in both groups. FSR was associated with a lower recurrence rate than VAAFT in the management of complex anal fistulae in this single-centre study but the study was terminated early due to higher than predicted recurrence rate in both groups. NCT02585167 (http://www.clinicaltrials.org).

SUBMITTER: Sorensen KM

PROVIDER: S-EPMC8493008 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundIncidence of complications following obstetrical anal sphincter injury (OASI) during vaginal delivery are poorly defined. They are only studied in high level maternities, small cohorts, all stages of perineal tear or in low-income countries. The aim of our study was to describe complications after primary OASI repair following a vaginal delivery in all French maternity wards at short and midterm and to assess factors associated with complication occurrence.MethodsWe conducted a historical cohort study using the French nationwide claim database (PMSI) from January 2013 to December 2021. All women who sustained an OASI repair following a vaginal delivery were included and virtually followed-up for 2 years. Then, we searched for OASIS complications. Finally, we evaluated factors associated with OASIS complication repaired or not and OASIS complication repairs.ResultsAmong the 61,833 included women, 2015 (2.8%) had an OASI complication and 842 (1.16%) underwent an OASI complication repair. Women were mainly primiparous (71.6%) and 44.3% underwent an instrumental delivery. During a follow-up of 2 years, 0.6% (n = 463), 0.3% (n = 240), 0.2% (n = 176), 0.1% (n = 84), 0.06% (n = 43) and 0.01% (n = 5) of patients underwent second surgery for a perineal repair, a fistula repair, a sphincteroplasty, a perineal infection, a colostomy and a sacral nervous anal stimulation, respectively. Only one case of artificial anal sphincter was noticed. Instrumental deliveries (OR = 1.56 CI95%[1.29;1.9]), private for-profit hospitals (OR = 1.42 [1.11;1.82], reference group "public hospital"), obesity (OR = 1.36 [1;1.84]), stage IV OASIS (OR = 2.98 [2.4;3.72]), perineal wound breakdown (OR = 2.8 [1.4;5.48]), ages between 25 and 29 years old (OR = 1.59 [1.17;2.18], refence group "age between 13 and 24 years old") and 30 and 34 years old (OR = 1.57 [1.14; 2.16], refence group "age between 13 and 24 years old") were factors associated with OASIS complication repairs.ConclusionsMaternal age, stage IV OASIS, obesity, instrumental deliveries and private for-profit hospitals seemed to predict OASIS complications. Understanding factors associated with OASIS complications could be beneficial for the patient to inform them and to influence the patient's follow-up in order to prevent complications, repairs and maternal distress.

Project description:INTRODUCTION:Obstetric anal sphincter injury (OASIS) occurs in 5%-7% of normal deliveries and increases with vacuum extraction (VE) to 12%-14% in nulliparous women in Sweden. Lateral/mediolateral episiotomy may reduce the prevalence of OASIS at VE in nulliparous women. The current use of episiotomy is restrictive. The protective effect and consequences are uncertain. This trial will investigate if lateral episiotomy can reduce the prevalence of OASIS and assess short-term and long-term effects. METHODS AND ANALYSIS:This is a multicentre randomised controlled trial of lateral episiotomy versus no episiotomy in nulliparous women with a singleton, live fetus, after gestational week 34+0 with indication for VE. A lateral episiotomy of 4?cm is cut at crowning, 1-3?cm from the midline, at a 60° angle. The primary outcome is OASIS by clinical diagnosis analysed according to intention to treat. To demonstrate a 50% reduction in OASIS prevalence (from 12.4% to 6.2%), 710 women will be randomised at a 1:1 ratio. Secondary outcomes are pain, blood loss, other perineal injuries, perineal complications, Apgar score, cord pH and neonatal complications. Web-based questionnaires at baseline, 2?months, 1 and 5?years will be used to assess pain, incontinence, prolapse, sexual function, quality of life and childbirth experience. A subset of women will receive follow-up by pelvic floor sonography and pelvic examination. Mode of delivery and recurrence of OASIS/episiotomy in subsequent pregnancies will be assessed at 5 and 10 years using register data. ETHICS AND DISSEMINATION:The trial is open for enrolment. The trial has received ethical approval from the Regional Ethical Review Board of Stockholm and full funding from the Swedish Research Council. Women are interested in participation. The predominant restrictive view on episiotomy may limit recruitment. Results are of global interest and will be disseminated in peer-reviewed journals and at international congresses. TRIAL REGISTRATION NUMBER:NCT02643108; Pre-results.

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Video-assisted anal fistula treatment versus fistulectomy and sphincter repair in the treatment of high cryptoglandular anal fistula: a randomized clinical study.

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