RECRUITINGINTERVENTIONAL

Safety of Mesentery-embedding Surgery in Patients With Ileocolic Crohn's Disease on Biotherapy

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - The patient must have given their free and willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

PROCEDURE

ileocolic resection with extended mesenteric resection

The resection limits will be in healthy mesenteric areas. The restoration of continuity in one stage should be preferred. The choice of laparoscopy versus laparotomy is at the surgeon's discretion.

Locations (2)

CHU de Montpellier Hôpital St Eloi

Montpellier, France

CHU de Nîmes

Nîmes, France