Actively Recruiting
Safety of Mesentery-embedding Surgery in Patients With Ileocolic Crohn's Disease on Biotherapy
Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2026-03-16
30
Participants Needed
2
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
60% of patients with Crohn's disease will undergo surgery during their lifetime and without recurrence prevention treatment, 80% of patients will have an endoscopic recurrence within 1 year of surgery. This procedure is performed as close as possible to the gastrointestinal tract, but remaining mesenteric disease is a risk factor for recurrence. Mesentery resection has encouraging results on recurrence requiring reoperation, with a reduction of over 30% in recurrences compared with the standard technique. The study authors wish to evaluate the safety of ileocolic resection surgery involving the mesentery in patients with Crohn's disease treated with biotherapy. The study hypothesis is that mesentery surgery is no more risky than conventional (gold standard) surgery, and reduces the 6-month endoscopic recurrence rate in patients with ileocolic Crohn's disease on biotherapy requiring ileocolic resection.
CONDITIONS
Official Title
Safety of Mesentery-embedding Surgery in Patients With Ileocolic Crohn's Disease on Biotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 alpha: infliximab or adalimumab, vedolizumab, ustekinumab, or other biotherapy such as risankizumab
- Patient able to understand, write and read French
You will not qualify if you...
- 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 alpha (infliximab or adalimumab), vedolizumab, ustekinumab, risankizumab
- Contraindication to surgery, such as major cardiovascular comorbidities
- Pregnant, breast-feeding or parturient women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
CHU de Montpellier Hôpital St Eloi
Montpellier, France
Actively Recruiting
2
CHU de Nîmes
Nîmes, France, 30029
Actively Recruiting
Research Team
M
Martin BERTRAND
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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