Ireland
--:--IST
Active, not recruiting Observational

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

NCT03865823 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2019-03-01
Last updated
2025-09-23

Condition(s) studied

Anal Fistula

Investigational drug(s) / intervention(s)

pus sample

pus sample: A pus sample from the fistula will be taken by the doctor during this first consultation or, failing that, in the operating room before disinfection.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient over the age of 18, patient with an anus fistula with indication for surgical treatment Exclusion Criteria: * Cutaneous Suppuration, without fistula (e.g., Verneuil disease, boil)

Primary outcome measure(s)

  • Healing rate at 2 years after initial surgical management of anal fistula. — 2 years
    Healing is defined by the absence of anal pain, pus discharge and anal swelling reported by the patient.

Trial sites (1)

FacilityCityRegionStatus
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03865823 on ClinicalTrials.gov ↗ ← All trials in France