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

NCT03865823 | Active Not Recruiting

• 1 other identifier: D_ELK_2018_2
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anal Fistula

Keywords

anal fistula; anal infection

Outcome Measures

Primary Outcomes (1)

• Healing rate at 2 years after initial surgical management of anal fistula.

  Healing is defined by the absence of anal pain, pus discharge and anal swelling reported by the patient.

  2 years

Secondary Outcomes (8)

• Anal incontinence rate in participants operated for anal fistula, 2 years after initial care.

  Year 2

• Healing rate in participants operated for anal fistula, at 6, 12 and 24 months after initial care.

  Month 6, 12, 24

• Assessment of time to consolidated recovery.

  Month 24

• Description of the number of surgeries required to obtain a cure.

  2 years

• Bacteriological profile at the level of the fistula at the time of diagnosis and research into a possible role in the cure rate, the surgical technique used and the rate of post-operative incontinence.

  2 weeks

Study Arms (1)

anal Fistula

patient with anal fistula with indication to surgical treatment

Procedure: pus sample

Interventions

pus sample PROCEDURE

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.

anal Fistula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with an anus fistula with indication for surgical treatment

You may qualify if:

• Patient over the age of 18, patient with an anus fistula with indication for surgical treatment

You may not qualify if:

• Cutaneous Suppuration, without fistula (e.g., Verneuil disease, boil)

Sponsors & Collaborators

• Groupe Hospitalier Diaconesses Croix Saint-Simon: lead

Study Sites (1)

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, 75020, France

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 7, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)