Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease: A Multicenter Prospective Cohort Study

Conditions
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Crohn Disease, Recurrence, Crohn's Ileocolitis

Intervention / Treatment
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* Procedure: Extended mesenteric resection.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Prospective study arm involving an extended mesenteric ileocolic excision. | Procedure: Extended mesenteric resection.<br>* 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.<br>|
| No Intervention: Control Arm<br>Historical controls from a retrospective chart review of patients who had a limited ileocolic resection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with endoscopic recurrence at 6 months | Endoscopic recurrence after extended mesenteric ileocolic resection | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with endoscopic recurrence at 18 months | Endoscopic recurrence after extended mesenteric ileocolic resection. | 18 months | 
| Rates of recurrence requiring surgery by 2 years | Surgical recurrence after extended mesenteric ileocolic resection. | 24 months | 
| 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 |