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Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04266600
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborator:
Montreal General Hospital
Information provided by (Responsible Party):
Dr. Marylise Boutros, Jewish General Hospital

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).


Condition or disease Intervention/treatment Phase
Crohn Disease Recurrence Crohn's Ileocolitis Procedure: Extensive mesentery resection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease: A Multicenter Prospective Cohort Study
Actual Study Start Date : September 27, 2019
Estimated Primary Completion Date : September 27, 2021
Estimated Study Completion Date : September 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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.



Primary Outcome Measures :
  1. Endoscopic recurrence at 6 months [ Time Frame: 6 months ]
    Endoscopic recurrence after extended mesenteric ileocolic resection


Secondary Outcome Measures :
  1. 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

  2. Rates of recurrence requiring surgery by 2 years [ Time Frame: 24 months ]
    Surgical recurrence after extended mesenteric ileocolic resection

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266600


Contacts
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Contact: Marylise Boutros, MD 514-340-8222 ext 26821 marylise.boutros@mcgill.ca
Contact: Sender Liberman, MD 5149348486 sender.liberman@mcgill.ca

Locations
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Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Sender Liberman, MD    5149348486    sender.liberman@mcgill.ca   
Contact: Talat Bessissow, MD    5149348309    talat.bessissow@mcgill.ca   
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Marylise Boutros, MD    5143408222 ext 26821    marylise.boutros@mcgill.ca   
Sponsors and Collaborators
Jewish General Hospital
Montreal General Hospital

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Responsible Party: Dr. Marylise Boutros, Associate Professor of Surgery, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT04266600    
Other Study ID Numbers: MUHC-2020-5789
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes