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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
Extensive mesentery resection
Sponsored by
Jewish General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prospective arm (extended mesenteric resection)

Retrospective arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Endoscopic recurrence at 6 months
Endoscopic recurrence after extended mesenteric ileocolic resection

Secondary Outcome Measures

Endoscopic recurrence at 18 months
Endoscopic recurrence will be evaluated by the endoscopist and will be evaluated according to the Rutgeert's score
Rates of recurrence requiring surgery by 2 years
Surgical recurrence after extended mesenteric ileocolic resection
Post-operative complications
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
February 10, 2020
Last Updated
May 17, 2021
Sponsor
Jewish General Hospital
Collaborators
Montreal General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04266600
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
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
September 27, 2023 (Anticipated)
Study Completion Date
September 27, 2024 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
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. (limited mesenteric 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
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prospective arm (extended mesenteric resection)
Arm Type
Experimental
Arm Description
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.
Arm Title
Retrospective arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Extensive mesentery resection
Intervention Description
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 Information:
Title
Endoscopic recurrence at 6 months
Description
Endoscopic recurrence after extended mesenteric ileocolic resection
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Endoscopic recurrence at 18 months
Description
Endoscopic recurrence will be evaluated by the endoscopist and will be evaluated according to the Rutgeert's score
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
Post-operative complications
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
No
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
Marylise Boutros, MD
Phone
514-340-8222
Ext
26821
Email
marylise.boutros@mcgill.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Sender Liberman, MD
Phone
5149348486
Email
sender.liberman@mcgill.ca
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
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
5149348486
Email
sender.liberman@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Talat Bessissow, MD
Phone
5149348309
Email
talat.bessissow@mcgill.ca
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marylise Boutros, MD
Phone
5143408222
Ext
26821
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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