Understanding post-operative outcomes in Crohn's disease after ileocecal resection
Ileal Crohn's Disease and Post-operative Outcome: Prospective Cohort Study of the REMIND Group
This study is trying to learn more about how surgery for Crohn's disease affects recovery and the chances of the disease coming back by collecting samples and tracking patients after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 575 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Saint-Louis Hospital, Paris, France Academic / other |
| Drugs / interventions | ustekinumab |
| Locations | 17 sites (Liège and 16 other locations) |
| Trial ID | NCT03458195 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with Crohn's disease who are scheduled for ileocecal resection. It aims to collect extensive clinical and biological data to better understand factors influencing post-operative recurrence of the disease. Patients will undergo surgery, and various samples will be collected for analysis, including blood and biopsies. The study will also track clinical outcomes through endoscopic examinations scheduled after surgery to assess recurrence risk.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of Crohn's disease requiring ileocecal resection.
Not a fit: Patients with a history of dysplasia or cancer in the ileum or colon, or those who are pregnant, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for Crohn's disease patients, potentially reducing the risk of post-operative recurrence.
How similar studies have performed: Other studies have shown success in understanding post-operative outcomes in Crohn's disease, but this study's comprehensive approach to integrating clinical and biological data is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent obtained before any study-related activities * A diagnosis of CD, based on clinical, radiologic, endoscopic, or histological evidence. * Men and women ≥18 years of age * Required surgical intervention consisting in an ileocecal resection Exclusion Criteria: * Previous history of dysplasia or cancer in the ileum or colon * Unwillingness or inability to follow the procedures outlined in the protocol * Pregnant women
Where this trial is running
Liège and 16 other locations
- SART Tilman Hospital — Liège, Belgium (Recruiting)
- Amiens Hospital — Amiens, France (Recruiting)
- Haut-levêque Hospital — Bordeaux, France (Active_not_recruiting)
- Clermont-Ferrand Hospital — Clermont-Ferrand, France (Recruiting)
- Beaujon Hospital — Clichy, France (Recruiting)
- Henri Mondor Hospital — Créteil, France (Recruiting)
- Kremlin-Bicêtre Hospital — Le Kremlin-Bicêtre, France (Recruiting)
- Lille Hospital — Lille, France (Recruiting)
- Hôpital Nord, CHU Marseille — Marseille, France (Recruiting)
- Montpellier Hospital — Montpellier, France (Recruiting)
- Brabois Hospital — Nancy, France (Recruiting)
- Nantes Hospital — Nantes, France (Recruiting)
- Archet 2 Hospital — Nice, France (Recruiting)
- Saint Louis Hospital — Paris, France (Recruiting)
- Saint Antoine Hospital — Paris, France (Recruiting)
- South Lyon Hospital — Pierre-Bénite, France (Recruiting)
- Strasbourg Hospital — Strasbourg, France (Active_not_recruiting)
Study contacts
- Principal investigator: Matthieu ALLEZ, Pr — Remind
- Study coordinator: Matthieu ALLEZ, Pr
- Email: Matthieu.allez@aphp.fr
- Phone: +33(1) 42 49 95 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.