Crohn Disease, Crohn's Ileocolitis, Recurrence
Conditions
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.
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.
Interventions
PROCEDUREExtended mesenteric resection.
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.
Sponsors
Jewish General Hospital
Montreal General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with endoscopic recurrence at 6 months | 6 months | Endoscopic recurrence after extended mesenteric ileocolic resection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with endoscopic recurrence at 18 months | 18 months | Endoscopic recurrence after extended mesenteric ileocolic resection. |
| Rates of recurrence requiring surgery by 2 years | 24 months | Surgical recurrence after extended mesenteric ileocolic resection. |
| Rates of post-operative complications compared between study groups | 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. |
Countries
Canada
Contacts
Primary ContactSender Liberman, MD
Backup ContactMarylise Boutros, MD
Outcome results
None listed