Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease
- Conditions
- Crohn DiseaseRecurrenceCrohn's Ileocolitis
- Interventions
- Procedure: Extensive mesentery resection
- Registration Number
- NCT04266600
- Lead Sponsor
- Jewish General Hospital
- Brief Summary
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.
(limited mesenteric resection).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 29
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.
previous ileocolic resection other sites of CD intraabdominal sepsis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prospective arm (extended mesenteric resection) Extensive mesentery resection Surgery can be performed either laparoscopically or open depending on surgeon preference and the circumstances of the surgery. Surgeons will perform a high ligation of the ileocolic pedicle, between the superior mesenteric artery and the bifurcation of the ileal and right colic branches, and to fully mobilize the mesentery off of the retroperitoneum prior to bowel transection and anastomosis. The entire mesentery related to the specimen will be removed. Outcomes in the prospective arm will be compared to historical controls.
- Primary Outcome Measures
Name Time Method Endoscopic recurrence at 6 months 6 months Endoscopic recurrence after extended mesenteric ileocolic resection
- Secondary Outcome Measures
Name Time Method Post-operative complications 30 days Post-operative complications including: wound infections, anastomotic leak, intra-abdominal abscess, venous-thromboembolic complications, and primary ileus within 30 days of the first resection.
Endoscopic recurrence at 18 months 18 months Endoscopic recurrence will be evaluated by the endoscopist and will be evaluated according to the Rutgeert's score
Rates of recurrence requiring surgery by 2 years 24 months Surgical recurrence after extended mesenteric ileocolic resection
Trial Locations
- Locations (2)
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Montreal General Hospital
🇨🇦Montreal, Quebec, Canada