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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05759104
Collaborator
(none)
40
138

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Actual Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Treatment and Fate in Fistulizing Crohn's Disease in a Pediatric Population
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Jul 1, 2013
Anticipated Study Completion Date :
Jul 1, 2023

Outcome Measures

Primary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Minor patients (aged 3 to 18).

  • Diagnosed with Crohn's disease.

  • fistulizing crohn's disease

Exclusion Criteria:
  • perianal crohn disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CHABOT Caroline, Doctor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT05759104
Other Study ID Numbers:
  • 2022PI067
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by CHABOT Caroline, Doctor, Central Hospital, Nancy, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2023