Clinical Trial

Evaluation of the Recovery Rate and Postoperative Incontinence of Surgical Fistulas in a Cohort of a Reference Centre

Study acronym: PROFIL
Active, Not Recruiting
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Record status
This record was last updated September 23, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
Fistula is a pathology that can be complex and lead to treatment difficulties for the proctologist. The proctologist's objective is to treat the infection (anal fistula and abscess) with the minimum impact on anal continence. Drainage of the fistula pathway(s) and removal of infected tissue during initial surgery are essential. The treatment of upper trans-sphincterial fistulas, i. e. those that span more than half the height of the anal sphincter, poses risks to anal continence. It sometimes requires several times of surgical treatment. The study aim to investigate the fate of all patients treated for anal fistula in an expert team, in terms of impact on healing and anal continence and according to the type of anal fistula, the co-morbidity, the surgical techniques used and the bacterial flora responsible.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2019-03-04; most recent amendment 2025-09-17.
Status change: Recruiting → Active, Not Recruiting 2025-09-17
Trial Details
NCT Number NCT03865823
Lead Sponsor Groupe Hospitalier Diaconesses Croix Saint-Simon
Conditions Anal Fistula
Enrollment 600 participants
Start Date 2019-03-01
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-09-23