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Extended Mesenteric Excision for Crohn's Disease

N/A

Waitlist Available

Research Sponsored by Jewish General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults >18 years old with a diagnosis of Crohn's disease limited to the distal ileum/ileocolic region

No previous ileocolic resection

Must not have

Other sites of Crohn's disease

Previous ileocolic resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a more extensive surgery to remove the mesentery reduces disease recurrence in Crohn's patients.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects aren't listed for this surgical intervention, potential risks may include bleeding, infection, bowel injury or leaks from where intestines are sewn together.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My Crohn's disease affects only the end of my small intestine.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have an infection in my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Endoscopic recurrence at 6 months

Secondary study objectives

Endoscopic recurrence at 18 months

Post-operative complications

Rates of recurrence requiring surgery by 2 years

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 7Eligibility criteria met