Trial reportBMJ open2015
Therapeutic management of complex anal fistulas by installing a nitinol closure clip: study protocol of a multicentric randomised controlled trial--FISCLOSE.
Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02336867 (Therapeutic Management of Complex Anal Fistulas by Installing a Closure Clip), which is not on this map. Cited by 7 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Therapeutic Management of Complex Anal Fistulas by Installing a Closure Clip: Multicentre Randomized Controlled Trial
Who cites it
7 citing papers in PubMed, 20 citations in OpenAlex.
- Evidence outside the box: Minimally invasive treatment for anal fistula.World journal of gastrointestinal surgery · 2025Review
- Over-the-Scope Clip in the Treatment of Gastrointestinal Leaks and Perforations.Clinical endoscopy · 2021Article
- Efficacy of flap repair for anal fistula: study protocol for a systematic review of randomized controlled trial.Medicine · 2019Article
- Short-term outcomes of the over-the-scope clip proctology system for rectovaginal fistula repair: a prospective study.Techniques in coloproctology · 2019Article
- Micro-fragmented adipose tissue injection for the treatment of complex anal fistula: a pilot study accessing safety and feasibility.Techniques in coloproctology · 2018Article
- Five years of experience with the FiLaC™ laser for fistula-in-ano management: long-term follow-up from a single institution.Techniques in coloproctology · 2017Article
- Unexpected complication after radical (inguinal) orchidectomy: trans-sphincteric anoscrotal fistula.BMJ case reports · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionComplex anal fistulas are responsible for pain, faecal incontinence and impaired quality of life. The rectal mucosa advancement flap (RMAF) procedure to cover the internal opening of the fistula remains a strategy of choice. However, a new procedure for closing anal fistulas is now available with the use of a nitinol closure clip (OTSC Proctology, OVESCO), which should ensure a better healing rate. This procedure is currently becoming more widespread, though without robust scientific validation, and it is therefore essential to carry out a prospective evaluation in order to determine the efficacy and safety of this new medical device for complex anal fistulas. METHODS AND ANALYSIS: The FISCLOSE trial is aimed at evaluating the efficacy and safety of a nitinol closure clip compared to the RMAF procedure for the management of complex anal fistulas. This trial is a prospective, randomised, controlled, single-blind, bicentre and interventional study. Patients (n=46 per group) will be randomly assigned for management with either a closure clip or RMAF. The main objectives are to improve the healing rate of the anal fistula, lessen the postoperative pain and faecal incontinency, enhance the quality of life, and lower the number of reinterventions and therapeutic management costs. The primary outcome is the proportion of patients with a healed fistula at 3 months. The secondary outcomes are anal fistula healing (6 and 12 months), proctological pain (visual analogue scale), the faecal incontinence score (Jorge and Wexner questionnaire), digestive disorders and quality of life (Gastrointestinal Quality of Life Index and Euroqol EQ5D-3 L) up to 1 year. ETHICS AND DISSEMINATION: The study was approved by an independent medical ethics committee 1 (IRB00008526, CPP Sud-Est 6, Clermont-Ferrand, France) and registered by the competent French authority (ANSM, Saint Denis, France). The results will be disseminated in a peer-reviewed journal and presented at international congresses. TRIAL REGISTRATION NUMBER: NCT02336867; pre-result.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.