Extended Mesenteric Excision for Crohn's Disease

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Jewish General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Research Team

Eligibility Criteria

This trial is for adults over 18 with Crohn's Disease affecting only the distal ileum/ileocolic region, who haven't had previous ileocolic resections. It includes all forms of Crohn's presentations such as stricturing, fistulizing, and perforating. Those with prior surgeries in the area or disease at other sites are excluded.

Inclusion Criteria

My Crohn's disease comes in various forms, including stricturing and fistulizing.

I am over 18 and have Crohn's disease affecting the end of my small intestine.

I have not had surgery to remove part of my small and large intestine.

See 4 more

Exclusion Criteria

My Crohn's disease affects areas other than my intestines.

I have had surgery to remove part of my small and large intestine.

I have an infection in my abdomen.

Treatment Details

Interventions

Extensive mesentery resection (NA)

Trial OverviewThe study tests whether removing more of the mesentery (the tissue that attaches intestines to the back wall of the abdomen) during surgery can reduce recurrence of Crohn's Disease at six months post-operation compared to standard limited removal.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Prospective arm (extended mesenteric resection)Experimental Treatment1 Intervention

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.

Group II: Retrospective armActive Control1 Intervention

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.