title: Therapeutic management of complex anal fistulas by installing a nitinol closure clip: study protocol of a multicentric randomised controlled trial--FISCLOSE.
abstract: BACKGROUND
  Complex 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
  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.
  
  
  BACKGROUND
  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.
  
  
  BACKGROUND
  NCT02336867; pre-result.
authors.affiliation: CHU Clermont-Ferrand, service de Chirurgie Digestive, Clermont-Ferrand, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Dubois
authors.affiliation: CHU Clermont-Ferrand, service de Chirurgie Digestive, Clermont-Ferrand, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Carrier
authors.affiliation: CHU Clermont-Ferrand, Délégation à la Recherche Clinique et à l'Innovation, Clermont-Ferrand, France.
authors.forename: Bruno
authors.initials: B
authors.lastname: Pereira
authors.affiliation: CHU Clermont-Ferrand, service de Chirurgie Digestive, Clermont-Ferrand, France.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Gillet
authors.affiliation: CHU Grenoble, service de Chirurgie Digestive, Grenoble, France.
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Faucheron
authors.affiliation: CHU Clermont-Ferrand, service de Chirurgie Digestive, Clermont-Ferrand, France CHU Clermont-Ferrand, Délégation à la Recherche Clinique et à l'Innovation, Clermont-Ferrand, France INSERM, U1071, Clermont-Ferrand, France Université d'Auvergne, Clermont-Ferrand, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Pezet
authors.affiliation: CHU Clermont-Ferrand, Délégation à la Recherche Clinique et à l'Innovation, Clermont-Ferrand, France Université d'Auvergne, Clermont-Ferrand, France INSERM, U1107 NEURO-DOL, Clermont-Ferrand, France.
authors.forename: David
authors.initials: D
authors.lastname: Balayssac
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012003:Rectal Fistula / Q000601:surgery*; D012007:Rectum / Q000601:surgery; D016037:Single-Blind Method; D053831:Surgical Fixation Devices; D013524:Surgical Flaps; D016896:Treatment Outcome; D058106:Wound Closure Techniques / Q000295:instrumentation*; D055815:Young Adult
chemical_list: D000497:Alloys; C013616:nitinol