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

NCT ID: NCT06856044

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2028-03-31

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with Crohn Disease

Group Type: EXPERIMENTAL

ileocolic resection with extended mesenteric resection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin BERTRAND

Role: PRINCIPAL_INVESTIGATOR

CHU de Nimes

Locations

CHU de Montpellier Hôpital St Eloi

Montpellier, , France

Site Status: RECRUITING

CHU de Nîmes

Nîmes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Martin BERTRAND

Role: CONTACT

martin.bertrand@chu-nimes.fr

04 66 68 31 43

Facility Contacts

Thomas BARDOL

Role: primary

t-bardol@chu-montpellier.fr

04 67 33 77 31

Anissa MEGZARI

Role: primary

drc@chu-nimes.fr

04 66 68 42 36

Other Identifiers

NIMAO/2023-2/MB-01

Identifier Type: -

Identifier Source: org_study_id