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| Name | Class |
|---|---|
| Jewish General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Prospective study arm involving an extended mesenteric ileocolic excision. |
|
| Control Arm | No Intervention | Historical controls from a retrospective chart review of patients who had a limited ileocolic resection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended mesenteric resection. | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with endoscopic recurrence at 6 months | Endoscopic recurrence after extended mesenteric ileocolic resection | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sender Liberman, MD | Contact | (514) 934-8486 | sender.liberman@mcgill.ca | |
| Marylise Boutros, MD | Contact | (514) 340-8222 | 28400 | maryliseboutros@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal General Hospital | Recruiting | Montreal | Quebec | H3G 1A4 | Canada |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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 |
| Jewish General Hospital | Not yet recruiting | Montreal | Quebec | H3T 1E2 | Canada |
|
| D007410 | Intestinal Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |