Safety of Mesentery-embedding Surgery in Patients With Ileocolic Crohn's Disease on Biotherapy (RIC-2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Procedure: ileocolic resection with extended mesenteric resection

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin BERTRAND; Phone Number: 04 66 68 31 43; Email: martin.bertrand@chu-nimes.fr

Study Locations

• France
  • Montpellier, France
    • Recruiting
    • CHU de Montpellier Hôpital St Eloi
    • Contact: Thomas BARDOL; Phone Number: 04 67 33 77 31; Email: t-bardol@chu-montpellier.fr
  • Nîmes, France, 30029
    • Recruiting
    • CHU de Nîmes
    • Contact: Anissa MEGZARI; Phone Number: 04 66 68 42 36; Email: drc@chu-nimes.fr
    • Principal Investigator: Martin BERTRAND

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with Crohn Disease	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-surgical complication rate	Percentage, graded according to the Clavien-Dindo Classification	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative endoscopic recurrence	Yes/No according to Rutgeerts classification (i0-i4), using a cut-off score ≥ i2	6 months
Surgical time of the ileocolic resection technique	Minutes	End of surgery
Intraoperative bleeding	If yes, volume (ml)	End of surgery
Length of hospital stay	Days	End of hospitalization (max 1 month)
Presence of intra- and post-operative complications	Yes/no	Immediately following surgery
Number of intra- and post-operative complications	Number	Immediately following surgery
Time until resumption of transit following surgery	Number of days between surgery and resumption of transit	Following surgery (maximum 5 days)
Time until resumption of eating	Number of days between surgery and resumption of eating	Following surgery (average 1 day)
Presence of myenteric plexitis with at least one inflammatory cell at proximal ileal resection margin	Classed as: Absent; 1-3 inflammatory cells; 4-9; or 10+	Immediately following surgery
Number of lymph nodes in the histological specimen	Number	Immediately following surgery
Resection not in healthy margin	(Yes/No)	Immediately following surgery
Length of resected digestive tract	Centimeters	Immediately following surgery
Area of mesentery removed	Square centimeters	Immediately following surgery
C-reactive protein level		Day before surgery
C-reactive protein level		Day 2
C-reactive protein level		Day 4
C-reactive protein level		Month 1
C-reactive protein level		Month 6
Albuminemia		Day before surgery
Hemoglobinemia		Day before surgery
Hemoglobinemia		Day 2
Hemoglobinemia		Day 4
White blood cells		Day before surgery
White blood cells		Day 2
White blood cells		Day 4
Fecal calprotectin		Month 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Martin BERTRAND, CHU de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: NIMAO/2023-2/MB-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No