Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease

May 17, 2021 updated by: Dr. Marylise Boutros, Jewish General Hospital

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.

(limited mesenteric resection).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
        • Contact:
      • Montreal, Quebec, Canada, H3G 1A4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic recurrence at 6 months
Time Frame: 6 months
Endoscopic recurrence after extended mesenteric ileocolic resection
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic recurrence at 18 months
Time Frame: 18 months
Endoscopic recurrence will be evaluated by the endoscopist and will be evaluated according to the Rutgeert's score
18 months
Rates of recurrence requiring surgery by 2 years
Time Frame: 24 months
Surgical recurrence after extended mesenteric ileocolic resection
24 months
Post-operative complications
Time Frame: 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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jewish General Hospital

Collaborators

Montreal General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 27, 2019

Primary Completion (ANTICIPATED)

September 27, 2023

Study Completion (ANTICIPATED)

September 27, 2024

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 11, 2020

First Posted (ACTUAL)

February 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUHC-2020-5789

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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