NCT03458195Recruiting
Ileal Crohn's Disease and Post-operative Outcome: Prospective Cohort Study of the REMIND Group
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
Crohn's disease (CD), a chronic inflammatory process in intestinal segments leads to tissue damage. More than two thirds of CD patients need intestinal resection. Symptomatic clinical recurrence occurs in 60% by 10 years. The principal factors affecting postoperative recurrence are active smoking, penetrating disease, perianal lesions history, prior intestinal resection, small bowel resection extent, and prophylaxis treatment absence. Ileocolonoscopy within one year of surgery can predict clinical recurrence risk. Different therapies are proposed after surgery, to prevent post-operative recurrence : Thiopurines, 6-mercaptopurine (positive for clinical and endoscopic postoperative recurrence prevention), Anti-tumour necrosis factor therapy (anti-TNF), the most effective therapy. Intestinal microbiota acts as a central factor in the CD pathogenesis, and fecal stream role is clearly shown. Various changes in luminal flora with a possible link to local inflammation was also demonstrated. Bacteria associated with postoperative recurrence could be more pathogenic as adherent invasive E coli (AIEC), which could be a pathogen in CD through several mechanisms including increased mucosal colonization, adherence, replication and induction of TNF secretion. Alternatively, postoperative CD recurrence could be linked to a protective commensal species lack, such as Faecalibacterium prausnitzii. Microscopic inflammation occurs as early as 8 days after anastomosis in the neoterminal ileum mucosa. IL6, IL10 and TGFb levels, measured in neoterminal ileum early after surgery are associated with different rates of postoperative recurrence. It suggests cytokines implication in postoperative recurrence. T cells are major players in the intestinal immune response. The presence at time of surgery and persistence of disease inducing T cell clonal expansions could play an important role in post-operative recurrence. The main objective is to define a classification of ileal Crohn's Disease based on data integration on a large cohort of patients.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 575 (estimated)
- First submitted
- 1 Mar 2018
- Start date
- 10 Dec 2009
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- Saint-Louis Hospital, Paris, France
- Diseases
- Crohn's disease
- NCT number
- NCT03458195
What you commit to
- Study type: Interventional
- Planned participants: 575
- From 10 Dec 2009 to the primary completion date, 31 Dec 2030
- 17 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous history of dysplasia or cancer in the ileum or colon
Other
- Unwillingness or inability to follow the procedures outlined in the protocol
- Pregnant women
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SART Tilman Hospital Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Amiens hospital Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| Haut-Lévêque Hospital Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Clermont-Ferrand Hospital Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Beaujon Hospital Coordinator of this site? Confirm its status | Clichy | France | Recruiting |
| Henri Mondor Hospital Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| Kremlin-Bicêtre Hospital Coordinator of this site? Confirm its status | Le Kremlin-Bicêtre | France | Recruiting |
| Lille Hospital Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Hôpital Nord - Chu Marseille Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Montpellier Hospital Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| Brabois Hospital Coordinator of this site? Confirm its status | Nancy | France | Recruiting |
| Nantes Hospital Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Archet 2 Hospital Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Saint Louis Hospital Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Saint-Antoine Hospital Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| South Lyon Hospital Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Strasbourg Hospital Coordinator of this site? Confirm its status | Strasbourg | France | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.