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

Primary Purpose

Crohn Disease, Recurrence, Crohn's Ileocolitis

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Extended mesenteric resection.
Sponsored by
Montreal General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Montreal General HospitalRecruiting
  • Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

Prospective study arm involving an extended mesenteric ileocolic excision.

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

Outcomes

Primary Outcome Measures

Number of participants with endoscopic recurrence at 6 months
Endoscopic recurrence after extended mesenteric ileocolic resection

Secondary Outcome Measures

Number of participants with endoscopic recurrence at 18 months
Endoscopic recurrence after extended mesenteric ileocolic resection.
Rates of recurrence requiring surgery by 2 years
Surgical recurrence after extended mesenteric ileocolic resection.
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.

Full Information

First Posted
August 31, 2020
Last Updated
April 5, 2022
Sponsor
Montreal General Hospital
Collaborators
Jewish General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04539665
Brief Title
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.
Official Title
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease: A Multicenter Prospective Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montreal General Hospital
Collaborators
Jewish General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Recurrence, Crohn's Ileocolitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Prospective study arm involving an extended mesenteric ileocolic excision.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Historical controls from a retrospective chart review of patients who had a limited ileocolic resection.
Intervention Type
Procedure
Intervention Name(s)
Extended mesenteric resection.
Intervention Description
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 Information:
Title
Number of participants with endoscopic recurrence at 6 months
Description
Endoscopic recurrence after extended mesenteric ileocolic resection
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of participants with endoscopic recurrence at 18 months
Description
Endoscopic recurrence after extended mesenteric ileocolic resection.
Time Frame
18 months
Title
Rates of recurrence requiring surgery by 2 years
Description
Surgical recurrence after extended mesenteric ileocolic resection.
Time Frame
24 months
Title
Rates of post-operative complications compared between study groups
Description
Post-operative complications including: wound infections, anastomotic leak, intra-abdominal abscess, venous-thromboembolic complications, and primary ileus within 30 days of the first resection.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sender Liberman, MD
Phone
(514) 934-8486
Email
sender.liberman@mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Marylise Boutros, MD
Phone
(514) 340-8222
Ext
28400
Email
maryliseboutros@gmail.com
Facility Information:
Facility Name
Montreal General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sender Liberman, MD
Phone
(514) 934-8486
Email
sender.liberman@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Bessissow Talat, MD
Phone
(514) 934-8309
Email
talat.bessissow@mcgill.ca
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marylise Boutros, MD
Phone
(514) 340-8222
Ext
28400
Email
marylise.boutros@mcgill.ca

12. IPD Sharing Statement

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

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