Ileocolic resection with extended mesenteric removal for Crohn's disease
Etude Prospective Exploratoire Pilote de sécurité, d'Une Chirurgie Emportant le mésentère Chez Les Patients Porteurs d'Une Maladie de Crohn Avec Atteinte iléo-colique Sous biothérapie
This trial will try removing more of the mesentery during ileocolic surgery in people with Crohn's disease who are on biologic medicines to see if it is safe and reduces early endoscopic recurrence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Drugs / interventions | infliximab, adalimumab, vedolizumab, ustkinumab, risankizumab, risankinumab |
| Locations | 2 sites (Montpellier and 1 other locations) |
| Trial ID | NCT06856044 on ClinicalTrials.gov |
What this trial studies
This is an interventional surgical study of extended mesenteric resection performed during ileocolic resection in patients with Crohn's disease who are receiving biologic therapy. Eligible participants have histologically proven ileocolic Crohn's disease requiring resection and are treated with anti-TNF agents, vedolizumab, ustekinumab, risankizumab, or similar biologics. Enrolled patients will undergo ileocolic resection with extended removal of the mesentery and be followed for perioperative safety and endoscopic recurrence, with planned endoscopic assessment at six months. The study tests the hypothesis that mesenteric resection is no more risky than standard surgery and may lower six-month endoscopic recurrence rates.
Who should consider this trial
Good fit: Adults with histologically confirmed ileocolic Crohn's disease who require ileocolic resection, are on approved biologic therapy, can undergo endoscopic follow-up, and can read and write French are ideal candidates.
Not a fit: Patients not receiving biologic therapy, those with contraindications to surgery, pregnant or breastfeeding women, and patients unable to complete endoscopic follow-up are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, this approach could lower early endoscopic recurrence and reduce the need for repeat surgery after ileocolic resection.
How similar studies have performed: Previous surgical series have reported encouraging results for mesenteric resection with over a 30% reduction in recurrence requiring reoperation versus standard technique, but randomized confirmation is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient must have given their free and informed consent and signed the consent form * The patient must be a member or beneficiary of a health insurance plan * Patient with histologically proven Crohn's disease * Patient who has undergone ileocolic resection and whose disease site is accessible to endoscopic follow-up (first or repeat operation) * Patient on anti-TNF α: infliximab or adalimumab (ECCO 2014 recommendation), vedolizumab, ustkinumab, or other biotherapy (e.g. risankizumab) * Patient able to understand, write and read French Exclusion Criteria: * The patient is participating in an interventional study * The patient is under safeguard of justice or state guardianship * Medical treatment other than biotherapies including anti-TNF α (infliximab or adalimumab), vedolizumab, ustkinumab, risankinumab * Contraindication to surgery, such as major cardiovascular comorbidities * Pregnant, breast-feeding or parturient women
Where this trial is running
Montpellier and 1 other locations
- CHU de Montpellier Hôpital St Eloi — Montpellier, France (Recruiting)
- CHU de Nîmes — Nîmes, France (Recruiting)
Study contacts
- Principal investigator: Martin BERTRAND — CHU de Nimes
- Study coordinator: Martin BERTRAND
- Email: martin.bertrand@chu-nimes.fr
- Phone: 04 66 68 31 43
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.