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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Montpellier Hôpital St Eloi
RECRUITING
Montpellier
CHU de Nîmes
RECRUITING
Nîmes
Contact Information
Primary
Martin BERTRAND
martin.bertrand@chu-nimes.fr
04 66 68 31 43
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2028-03
Participants
Target number of participants: 30
Treatments
Experimental: Patient with Crohn Disease
Sponsors
Leads: Centre Hospitalier Universitaire de Nīmes

This content was sourced from clinicaltrials.gov