NCT04539665

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

Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease: A Multicenter Prospective Cohort Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Montreal General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Crohn Disease
• Recurrence
• Crohn's Ileocolitis

Interventions

Type	Name	Description
PROCEDURE	Extended mesenteric resection.	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.

Timeline

• Start date: 2019-09-27
• Primary completion: 2022-12-30
• Completion: 2024-06-30
• First posted: 2020-09-07
• Last updated: 2022-04-07

Locations

2 sites across 1 country: Canada