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

Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease: A Multicenter Prospective Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrence; Crohn Disease; Crohn's Ileocolitis
• Intervention / Treatment: Procedure: Extended mesenteric 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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sender Liberman, MD; Phone Number: (514) 934-8486; Email: sender.liberman@mcgill.ca
• Study Contact Backup: Name: Marylise Boutros, MD; Phone Number: 28400 (514) 340-8222; Email: maryliseboutros@gmail.com

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3G 1A4
      • Recruiting
      • Montreal General Hospital
      • Contact: Sender Liberman, MD; Phone Number: (514) 934-8486; Email: sender.liberman@mcgill.ca
      • Contact: Bessissow Talat, MD; Phone Number: (514) 934-8309; Email: talat.bessissow@mcgill.ca
    • Montréal, Quebec, Canada, H3T 1E2
      • Not yet recruiting
      • Jewish General Hospital
      • Contact: Marylise Boutros, MD; Phone Number: 28400 (514) 340-8222; Email: marylise.boutros@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Prospective study arm involving an extended mesenteric ileocolic excision.	Procedure: Extended mesenteric resection.; Patients will undergo an ileocolic resection involving high ligation of the ileocolic pedicle, complete mobilization of the mesentery off of the retroperitoneum, and resection of the entire mesentery related to the specimen.
No Intervention: Control Arm; Historical controls from a retrospective chart review of patients who had a limited ileocolic resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with endoscopic recurrence at 6 months	Endoscopic recurrence after extended mesenteric ileocolic resection	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Montreal General Hospital
• Collaborators: Jewish General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2019
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Recurrence; Crohn Disease
• Other Study ID Numbers: crohn's mesentery

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No