Postoperative Progression of the Disease Following Extensive Versus Limited Mesenteric Excision for Crohn's Disease

Study Overview
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Brief Summary
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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
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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).

Official Title
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The MESOCOLIC Trial: Mesenteric Excision Surgery or Conservative Limited Resection in Crohn's Disease

Conditions
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Postoperative Surgical Recurrence

Intervention / Treatment
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* Procedure: Extensive mesenteric resection
* Procedure: Limited mesenteric excision


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extensive mesenteric resection<br>Mesenteric is resected avoiding the root region, i.e. 1 cm from the root of ileocolic artery and vein. | Procedure: Extensive mesenteric resection<br>* The mesentery is resected avoiding the root region.<br>|
| Active Comparator: Limited mesenteric excision<br>Mesentery is retained, i.e. Close shave or 3 cm from the border of bowel (using whatever approach - clips, or haemostatic vessel sealing device). | Procedure: Limited mesenteric excision<br>* The mesentery is retained.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulated 5-year postoperative surgical recurrence | The requirement for repeat surgery for a Crohn's disease related indication. | 5 years after the first surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accumulated 5-year endoscopic recurrence | Disease proximal to the anastomosis or in the perianastomotic are considered to be a endoscopic recurrence (Rutgeert's score i2, or higher, disease in other sites is not considered recurrence) | 5 years after the first surgery | 
| Accumulated 5-year clinical recurrence | The presence of endoscopic disease (i2, or higher) or radiological evidence plus the presence of symptoms attributable to Crohn's disease that are severe enough to require medical or surgical treatment. | 5 years after the first surgery |