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

Study acronym: PROFIL
StatusActive, Not Recruiting
PhaseNot specified
Started
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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.

Record History

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  1. Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Secondary endpoints expanded, about 108 words
    • Site details revised
    v4
  2. Primary and study completion dates: Mar 2025 to Mar 2026v3
  3. Primary and study completion dates: Mar 2023 to Mar 2025v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03865823
Lead Sponsor Groupe Hospitalier Diaconesses Croix Saint-Simon
Conditions
(from sponsor)		 Anal Fistula
Related terms Rectal Fistula
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov