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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study 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.

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

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.

0 / 4Eligibility criteria met

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

137 Previous Clinical Trials

272,015 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrolment capacity for this clinical trial?

"Affirmative, clinicaltrials.gov states that this comparative study is accepting volunteers; it was initially posted on September 27th 2019 and the last update to its records occurred May 17th 2021. There are 29 positions open at two different sites."

Answered by AI

Is there capacity for additional participants in this trial?

"Affirmative, clinicaltrials.gov reveals that the trial is still seeking participants after being first posted on September 27th 2019 and last updated on May 17th 2021. 29 individuals must be recruited from two medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease

Dr. Marylise Boutros 2019. "Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04266600.

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