NCT06856044 Safety of Mesentery-embedding Surgery in Patients With Ileocolic Crohn's Disease on Biotherapy
| NCT ID | NCT06856044 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-09-15 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Martin BERTRAND
PRINCIPAL INVESTIGATOR
CHU de Nimes
Frequently Asked Questions
Who can join the NCT06856044 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06856044 currently recruiting?
Yes, NCT06856044 is actively recruiting participants. Contact the research team at martin.bertrand@chu-nimes.fr for enrollment information.
Where is the NCT06856044 trial being conducted?
This trial is being conducted at Montpellier, France, Nîmes, France.
Who is sponsoring the NCT06856044 clinical trial?
NCT06856044 is sponsored by Centre Hospitalier Universitaire de Nīmes. The principal investigator is Martin BERTRAND at CHU de Nimes. The trial plans to enroll 30 participants.