Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04266600
• Other study ID #: MUHC-2020-5789
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: September 27, 2024

Study information

• Verified date: May 2021
• Source: Jewish General Hospital
• Contact: Marylise Boutros, MD
• Phone: 514-340-8222
• Email: marylise.boutros[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: September 27, 2024
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Ileocolitis
• Recurrence

Intervention

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

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Jewish General Hospital	Montreal General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic recurrence at 6 months	Endoscopic recurrence after extended mesenteric ileocolic resection	6 months
Secondary	Endoscopic recurrence at 18 months	Endoscopic recurrence will be evaluated by the endoscopist and will be evaluated according to the Rutgeert's score	18 months
Secondary	Rates of recurrence requiring surgery by 2 years	Surgical recurrence after extended mesenteric ileocolic resection	24 months
Secondary	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.	30 days