Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.

Not Applicable

• Conditions: Recurrence; Crohn Disease; Crohn's Ileocolitis
• Interventions: Procedure: Extended mesenteric resection.

• Registration Number: NCT04539665
• Lead Sponsor: Montreal General Hospital

Brief Summary

The study is looking at the role of the mesentery in disease recurrence for ileocolic Crohn's disease. It is a prospective study that has been designed to perform extended mesenteric excision on patients undergoing their first ileocolic resection for Crohn's disease. Endoscopic recurrence will be monitored with the hypothesis that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection.

Detailed Description

The current standard of care for ileocolic Crohn's disease (CD) is a limited mesenteric resection. There is growing, but still limited, evidence that extended mesenteric excision during ileocolic resection is beneficial in decreasing disease recurrence. We propose a prospective multicenter cohort study to better understand the role of extended mesenteric excision in ileocolic CD and how it affects disease recurrence. The primary outcome of this study will be the rate of endoscopic recurrence at 6 months in patients undergoing first-time resection for ileocolic CD. Secondary outcomes will include endoscopic recurrence at 18 months and rates of recurrence requiring surgery by 2 years. These outcomes will be compared to historical controls (limited mesenteric resection). Our hypothesis is that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection. As seen in previous studies, advanced mesenteric and mucosal disease predicts increased surgical recurrence.

Study Timeline

• Study Start: 2019-09-27
• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-07
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-07
• Primary Completion: 2022-12-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• adults >18 years old
• diagnosis of CD limited to the distal ileum/ileocolic region
• no previous ileocolic resection
• all forms of CD presentation will be included - stricturing, fistulizing, perforating etc.

Exclusion Criteria

• previous ileocolic resection
• other sites of CD
• intraabdominal sepsis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Extended mesenteric resection.	Prospective study arm involving an extended mesenteric ileocolic excision.

Primary Outcome Measures

Name	Time	Method
Number of participants with endoscopic recurrence at 6 months	6 months	Endoscopic recurrence after extended mesenteric ileocolic resection

Secondary Outcome Measures

Name	Time	Method
Rates of post-operative complications compared between study groups	30 days	Post-operative complications including: wound infections, anastomotic leak, intra-abdominal abscess, venous-thromboembolic complications, and primary ileus within 30 days of the first resection.
Number of participants with endoscopic recurrence at 18 months	18 months	Endoscopic recurrence after extended mesenteric ileocolic resection.
Rates of recurrence requiring surgery by 2 years	24 months	Surgical recurrence after extended mesenteric ileocolic resection.

Trial Locations

Locations (2)

Montreal General Hospital; 🇨🇦 Montréal, Quebec, Canada

Jewish General Hospital; 🇨🇦 Montréal, Quebec, Canada