Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease

NCT04266600 | Unknown

• 1 other identifier: MUHC-2020-5789
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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. (limited mesenteric resection).

Conditions

Crohn Disease; Recurrence; Crohn's Ileocolitis

Outcome Measures

Primary Outcomes (1)

• Endoscopic recurrence at 6 months

  Endoscopic recurrence after extended mesenteric ileocolic resection

  6 months

Secondary Outcomes (3)

• Endoscopic recurrence at 18 months

  18 months

• Rates of recurrence requiring surgery by 2 years

  24 months

• Post-operative complications

  30 days

Study Arms (2)

Prospective arm (extended mesenteric resection)

EXPERIMENTAL

Surgery can be performed either laparoscopically or open depending on surgeon preference and the circumstances of the surgery. Surgeons will perform a high ligation of the ileocolic pedicle, between the superior mesenteric artery and the bifurcation of the ileal and right colic branches, and to fully mobilize the mesentery off of the retroperitoneum prior to bowel transection and anastomosis. The entire mesentery related to the specimen will be removed. Outcomes in the prospective arm will be compared to historical controls.

Procedure: Extensive mesentery resection

Retrospective arm

NO INTERVENTION

Retrospective patient data will be obtained by querying the Opera operating room database of both study institutions. Electronic records will be analyzed for all patients undergoing a first-time ileocolic resection for Crohn's Disease between January 1, 2009 - December 31, 2018.

Interventions

Extensive mesentery resection PROCEDURE

Surgeons will perform a high ligation of the ileocolic pedicle, between the superior mesenteric artery and the bifurcation of the ileal and right colic branches, and to fully mobilize the mesentery off of the retroperitoneum prior to bowel transection and anastomosis

Prospective arm (extended mesenteric resection)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• previous ileocolic resection other sites of CD intraabdominal sepsis

Sponsors & Collaborators

• Jewish General Hospital: lead
• Montreal General Hospital: collaborator

Study Sites (2)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Recurrence

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marylise Boutros, MD

CONTACT

514-340-8222; marylise.boutros@mcgill.ca

Sender Liberman, MD

CONTACT

5149348486; sender.liberman@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: September 27, 2019
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2024
• Last Updated: May 19, 2021

Record last verified: 2021-05

Locations

CA (2)