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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Montreal General Hospital
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Start Date
September 27, 2019
Primary Completion Date
December 30, 2022
Completion Date
June 30, 2024
Last Updated
April 7, 2022
30
ESTIMATED participants
Extended mesenteric resection.
PROCEDURE
Lead Sponsor
Montreal General Hospital
Collaborators
NCT06237452
NCT05739825
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05467891