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NA

Extended Mesenteric Excision for Crohn's Disease

N/A
Recruiting
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

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.Check my eligibility
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.See study design
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:
Select...
My Crohn's disease affects areas other than my intestines.
Select...
I have had surgery to remove part of my small and large intestine.
Select...
I have an infection in my abdomen.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Endoscopic recurrence at 6 months
Secondary outcome measures
Endoscopic recurrence at 18 months
Post-operative complications
Rates of recurrence requiring surgery by 2 years

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.

Find a Location

Who is running the clinical trial?

Montreal General HospitalOTHER
17 Previous Clinical Trials
10,008 Total Patients Enrolled
Jewish General HospitalLead Sponsor
138 Previous Clinical Trials
272,365 Total Patients Enrolled

Media Library

Extensive mesentery resection (NA) Clinical Trial Eligibility Overview. Trial Name: NCT04266600 — N/A
Crohn's Disease Research Study Groups: Prospective arm (extended mesenteric resection), Retrospective arm
Crohn's Disease Clinical Trial 2023: Extensive mesentery resection Highlights & Side Effects. Trial Name: NCT04266600 — N/A
Extensive mesentery resection (NA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04266600 — N/A
~5 spots leftby Jul 2025