Mesenteric SParIng Versus Central mesenterectomY in Ileocolic Resection for Terminal Ileitis in Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this multicenter randomised controlled trial is to analyse the six month endoscopic recurrence following a mesenteric sparing versus a central mesenterectomy performing an ileocolic resection for CD.

Detailed Description
-----------------
There is emerging evidence to suggest that Crohn's disease (CD) may be a disease of the mesentery rather than just of the bowel alone. A more extensive central mesenterectomy (up to the level of the ileocolic artery), in order to remove an increased volume of affected mesentery to prevent postoperative CD, has been suggested to lead to beneficial results. It is hypothesised that patients who undergo a central mesenterectomy during an ileocolic resection compared to a mesenteric sparing ileocolic resection will have decreased recurrence rates.

Official Title
-----------------
Mesenteric SParIng Versus Central mesenterectomY in Ileocolic Resection for Terminal Ileitis in Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Procedure: Mesenteric sparing ileocolic resection
* Procedure: Central mesenterectomy ileocolic resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Ileocolic disease with an indication for ileocecal resection Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted. All patients should have undergone a colonoscopy and MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease. Ability to comply with protocol. Competent and able to provide written informed consent. Patient must have been discussed in the local MDT Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: Inability to give informed consent. patients less than 16 years of age. Patients undergoing repeated ileocolic resection. Clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient. History of cancer < 5 years which might influence patients prognosis Emergent operation. Pregnant or breast feeding. Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with Crohn's disease will be randomised in a 1:1 ratio for mesenteric sparing versus central mesenterectomy when performing an ileocolic resection for Crohn's disease
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mesenteric Sparing ileocolic resection<br>Standard procedure for CD, ileocolic resection without removal of the mesentery. | Procedure: Mesenteric sparing ileocolic resection<br>* Mesentery left in situ<br>|
| Active Comparator: Central mesenterectomy ileocolic resection<br>Experimental procedure for CD: ileocolic resection in which the mesentery is taken up to the level of the ileocolic trunc. | Procedure: Central mesenterectomy ileocolic resection<br>* Mesentery is taken up to the level of the ileocolic trunk<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The post-operative endoscopic recurrence of Crohn's disease at six months following ileocolic resection |  | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity | Number of patients with Postoperative morbidity | 30 days after surgery | 
| Clinical recurrence rate following ileocolic resection | Number of patients with Clinical recurrence rate following ileocolic resection | 1 year after surgery | 
| The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence | .The need for restarting immunosuppressive medication within the first year postoperatively for endoscopic or clinical recurrence | 1 year after surgery | 
| The 5 year reoperation rate for recurrence of disease at the anastomotic site. | The 5 year reoperation rate for recurrence of disease at the anastomotic site. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mesenteric Sparing, Extended Mesenterectomy, Crohn's Disease, Ileocolic