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

February 10, 2021 updated by: Groupe Hospitalier Diaconesses Croix Saint-Simon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with an anus fistula with indication for surgical treatment

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
anal Fistula
patient with anal fistula with indication to surgical treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify the risk factors, including infectious, of failure of the surgery of the fistula in an expert center
Time Frame: 2 years
2 year recovery rate after initial surgery of anal fistula
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ANTICIPATED)

March 1, 2025

Study Completion (ANTICIPATED)

March 1, 2025

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 4, 2019

First Posted (ACTUAL)

March 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D_ELK_2018_2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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