Recruiting

Observational Study

Sponsor:

Jewish General Hospital

Code:

NCT04266600

Conditions

Crohn Disease

Recurrence

Crohn's Ileocolitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Extensive mesentery resection

Study Details

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

Study ID

NCT04266600

Start date

Sep 27, 2019

Status verified date

May, 2021

Completion date

Sep 27, 2024

Anticipated

Primary completion date

Sep 27, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

29 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Prospective arm (extended mesenteric resection)

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.

no intervention: Retrospective arm

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

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

Primary outcome measure

  • Endoscopic recurrence at 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Marylise Boutros, MD

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

Sender Liberman, MD

5149348486sender.liberman@mcgill.ca

Locations

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Contacts

Sender Liberman, MD

5149348486sender.liberman@mcgill.ca

Talat Bessissow, MD

5149348309talat.bessissow@mcgill.ca

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Marylise Boutros, MD

5143408222marylise.boutros@mcgill.ca

More Information

Sponsor

Jewish General Hospital

Last update posted

May 19, 2021

Last verified

May, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jewish General Hospital on 2021-05-19.