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

Anal Fistula Clinical Trial

— PROFIL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03865823
• Other study ID #: D_ELK_2018_2
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: March 2025

Study information

• Verified date: February 2021
• Source: Groupe Hospitalier Diaconesses Croix Saint-Simon
• Contact: Elsa LAMBRESCAK, MD
• Phone: +33 1 44 64 20 45
• Email: elambrescak[@]hopital-dcss.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Groupe Hospitalier Diaconesses Croix Saint Simon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Diaconesses Croix Saint-Simon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the risk factors, including infectious, of failure of the surgery of the fistula in an expert center	2 year recovery rate after initial surgery of anal fistula	2 years