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: NCT04539665
• Other study ID #: crohn's mesentery
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2022
• Source: Montreal General Hospital
• Contact: Sender Liberman, MD
• Phone: (514) 934-8486
• Email: sender.liberman[@]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.

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: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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:
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Montreal General Hospital	Jewish General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with endoscopic recurrence at 6 months	Endoscopic recurrence after extended mesenteric ileocolic resection	6 months
Secondary	Number of participants with endoscopic recurrence at 18 months	Endoscopic recurrence after extended mesenteric ileocolic resection.	18 months
Secondary	Rates of recurrence requiring surgery by 2 years	Surgical recurrence after extended mesenteric ileocolic resection.	24 months
Secondary	Rates of post-operative complications compared between study groups	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