Recruiting

Mesenteric Excision

Sponsor:

Montreal General Hospital

Code:

NCT04539665

Conditions

Crohn Disease

Recurrence

Crohn's Ileocolitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Extended mesenteric 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.

Conditions

Crohn Disease

Recurrence

Crohn's Ileocolitis

Study ID

NCT04539665

Start date

Sep 27, 2019

Status verified date

Apr, 2022

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Dec 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: 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

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

Prospective study arm involving an extended mesenteric ileocolic excision.

no intervention: Control Arm

Historical controls from a retrospective chart review of patients who had a limited ileocolic resection.

Interventions

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.

Primary outcome measure

  • Number of participants with endoscopic recurrence at 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Sender Liberman, MD

(514) 934-8486sender.liberman@mcgill.ca

Marylise Boutros, MD

(514) 340-8222maryliseboutros@gmail.com

Locations

Montreal General Hospital

Recruiting

Montréal, Quebec, Canada, H3G 1A4

Contacts

Sender Liberman, MD

(514) 934-8486sender.liberman@mcgill.ca

Bessissow Talat, MD

(514) 934-8309talat.bessissow@mcgill.ca

More Information

Sponsor

Montreal General Hospital

Last update posted

Apr 7, 2022

Last verified

Apr, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montreal General Hospital on 2022-04-07.