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

NCT06856044 | Recruiting

• 1 other identifier: NIMAO/2023-2/MB-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Post-surgical complication rate

  Percentage, graded according to the Clavien-Dindo Classification

  30 days after surgery

Secondary Outcomes (26)

• Postoperative endoscopic recurrence

  6 months

• Surgical time of the ileocolic resection technique

  End of surgery

• Intraoperative bleeding

  End of surgery

• Length of hospital stay

  End of hospitalization (max 1 month)

• Presence of intra- and post-operative complications

  Immediately following surgery

Study Arms (1)

Patient with Crohn Disease

EXPERIMENTAL

Procedure: ileocolic resection with extended mesenteric resection

Interventions

ileocolic resection with extended mesenteric resection 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.

Patient with Crohn Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU de Montpellier Hôpital St Eloi

Montpellier, France

RECRUITING

CHU de Nîmes

Nîmes, 30029, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Martin BERTRAND

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin BERTRAND

CONTACT

04 66 68 31 43; martin.bertrand@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: March 4, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

FR (2)