Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population

Active, not recruiting

• Conditions: Crohn Disease

• Registration Number: NCT05759104
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

Crohn's disease is a inflammatory bowel disease evolving towards the destruction of the intestinal wall resulting in stenosing or perforating complications (fistulas, abscesses).

The treatment of perforating Crohn's disease is not codified.

Detailed Description

The old dogmas leading to surgery after failure of medical treatment have recently been overturned, particularly since the advent of anti-TNFs.

Biotherapies now have a central place, including for complicated forms. Previous studies have already looked at the usefulness of anti-TNFs in stenosing forms, or concerning ano-perineal lesions, but what about digestive fistulas.

Indeed, data are scarce, especially in paediatrics.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2013-07-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-25
• Study First Submitted QC: 2023-02-25
• Last Update Submitted: 2023-02-25
• Study First Posted: 2023-03-08
• Last Update Posted: 2023-03-08
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Minor patients (aged 3 to 18).
• Diagnosed with Crohn's disease.
• fistulizing crohn's disease

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Exclusion Criteria

• perianal crohn disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
No fistula	12 month	Complete remission = clinical remission and biological remission and iconographic remission: * clinical remission (asymptomatic at 12 months from inclusion).; * biological remission (normalization of biological parameters 12 months after inclusion).; * iconographic remission (no active lesion, and in particular no visualized fistula)