The MESOCOLIC Trial: Mesenteric Excision Surgery or Conservative Limited Resection in Crohn's Disease
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Jinling Hospital, China
- Enrollment
- 116
- Locations
- 1
- Primary Endpoint
- Accumulated 5-year postoperative surgical recurrence
Overview
Brief Summary
The study evaluates whether there is a reduction in the rate of postoperative progression of the disease following extensive mesenteric excision (EME), when compared to that of limited mesenteric excision (LME), in patients undergoing ileocolic resection for Crohn's disease. Half of participants will receive EME, while the other half will receive LME.
Detailed Description
EME and LME are the two surgical procedures which are commonly used in the treatment of Crohn's disease. However, the areas of the mesenteric tissue resected are different.
EME means that the mesentery is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein.
LME represents that the mesentery is retained, i.e. "Close shave" or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with Crohn's disease limited to the distal ileum and/or right colon receiving their index ileocolonic resection
- •Patients with a documented history of Crohn's disease based on endoscopic, radiological, or histological criteria
Exclusion Criteria
- •Pregnancy or willingness to become pregnant in the following year
- •Previous ileocolic resection history
- •Patients having Crohn's disease lesion at a gastrointestinal site other than the terminal ileum cecum, or right colon
- •Patients having an internal fistula which required resection of another segment of bowel
Outcomes
Primary Outcomes
Accumulated 5-year postoperative surgical recurrence
Time Frame: 5 years after the first surgery
The requirement for repeat surgery for a Crohn's disease related indication.
Secondary Outcomes
- Accumulated 5-year endoscopic recurrence(5 years after the first surgery)
- Accumulated 5-year clinical recurrence(5 years after the first surgery)
Investigators
Weiming Zhu
Chief of general surgery
Jinling Hospital, China