Analysis of Therapeutic Management Strategies for Anal Suppurations of Crohn's Disease

NCT04192825 | Recruiting

• 1 other identifier: 35RC18_8808_3T-LAP
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the optimal therapeutic combination associated with complete clinical and anatomical remission of anal suppurations of Crohn's disease at 12 months.

Conditions

Crohn Disease; Anal Suppurations; Drainage Procedure

Outcome Measures

Primary Outcomes (1)

• Clinical and anatomical healing

  The healing of anal fistula is defined by the combination of two criteria at 12 months : * MRI criteria = absence of a T2 hyper signal from the path(s) AND the absence of an abscess AND * Complete clinical response = no pain, no discharge, and no drain

  12 months.

Interventions

surgical treatment PROCEDURE

surgical drainage and/or surgical reconstruction procedures to anoperineal suppurations according to the doctor's decision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Person suffering from anal suppuration related to Crohn's Disease

You may qualify if:

• Persons over 18 years of age
• People suffering from anal suppuration of Crohn's disease for whom a drainage procedure is planned.
• Person who has received written and oral information about the protocol and has not expressed opposition to participate in the study.

You may not qualify if:

• No one who is unable to have an anesthetic, structural or psychological examination by MRI and/or surgery.
• Person planning a planned absence that could hinder participation in the research (travel abroad, relocation, impending transfer);
• Person with an associated pathology that is a priority for care;
• Vulnerable person (minors, persons under guardianship or curatorship, or deprived of their liberty by a judicial or administrative decision

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Centre Hospitalier de Rennes

Rennes, 35000, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Laurent SIPROUDHIS, PH-PD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

kristell COAT

CONTACT

299282555; kristell.coat@chu-rennes.fr

Direction de la recherche

CONTACT

299282555; drc@chu-rennes.fr

Study Design

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

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 10, 2019
• Study Start: February 3, 2020
• Primary Completion: August 3, 2025
• Study Completion (Estimated): August 3, 2028
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

FR (1)