Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.
1 other identifier
interventional
30
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 27, 2019
CompletedFirst Submitted
Initial submission to the registry
August 31, 2020
CompletedFirst Posted
Study publicly available on registry
September 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedApril 7, 2022
April 1, 2022
3.3 years
August 31, 2020
April 5, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with endoscopic recurrence at 6 months
Endoscopic recurrence after extended mesenteric ileocolic resection
6 months
Secondary Outcomes (3)
Number of participants with endoscopic recurrence at 18 months
18 months
Rates of recurrence requiring surgery by 2 years
24 months
Rates of post-operative complications compared between study groups
30 days
Study Arms (2)
Intervention Arm
EXPERIMENTALProspective study arm involving an extended mesenteric ileocolic excision.
Control Arm
NO INTERVENTIONHistorical controls from a retrospective chart review of patients who had a limited ileocolic resection.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- previous ileocolic resection
- other sites of CD
- intraabdominal sepsis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Montreal General Hospitallead
- Jewish General Hospitalcollaborator
Study Sites (2)
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Sender Liberman, Associate Professor of Surgery and Oncology (McGill University), PI
Study Record Dates
First Submitted
August 31, 2020
First Posted
September 7, 2020
Study Start
September 27, 2019
Primary Completion
December 30, 2022
Study Completion
June 30, 2024
Last Updated
April 7, 2022
Record last verified: 2022-04