Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04266600|
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 17, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease Recurrence Crohn's Ileocolitis||Procedure: Extensive mesentery resection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease: A Multicenter Prospective Cohort Study|
|Actual Study Start Date :||September 27, 2019|
|Estimated Primary Completion Date :||September 27, 2021|
|Estimated Study Completion Date :||September 27, 2021|
Experimental: Prospective arm (extended mesenteric 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.
Procedure: Extensive mesentery resection
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
No Intervention: Retrospective arm
Retrospective patient data will be obtained by querying the Opera operating room database of both study institutions. Electronic records will be analyzed for all patients undergoing a first-time ileocolic resection for Crohn's Disease between January 1, 2009 - December 31, 2018.
- Endoscopic recurrence at 6 months [ Time Frame: 6 months ]Endoscopic recurrence after extended mesenteric ileocolic resection
- Endoscopic recurrence at 18 months [ Time Frame: 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 [ Time Frame: 24 months ]Surgical recurrence after extended mesenteric ileocolic resection
- Post-operative complications [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266600
|Contact: Marylise Boutros, MD||514-340-8222 ext email@example.com|
|Contact: Sender Liberman, MDfirstname.lastname@example.org|
|Montreal General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3G 1A4|
|Contact: Sender Liberman, MD 5149348486 email@example.com|
|Contact: Talat Bessissow, MD 5149348309 firstname.lastname@example.org|
|Jewish General Hospital||Recruiting|
|Montreal, Quebec, Canada, H3T 1E2|
|Contact: Marylise Boutros, MD 5143408222 ext 26821 email@example.com|