Ileocolic resection with extended mesenteric removal for Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.