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Procedure

Extended Mesenteric Excision for Crohn's Disease

N/A

Recruiting

Research Sponsored by Montreal General Hospital

Eligibility Criteria Checklist

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

Must have

No previous ileocolic resection

Diagnosis of CD limited to the distal ileum/ileocolic region

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is looking at whether extend mesenteric excision can help reduce endoscopic recurrence of ileocolic Crohn's disease.

Who is the study for?

This trial is for adults over 18 with Crohn's Disease affecting the distal ileum/ileocolic region, who haven't had previous ileocolic resections. It includes all forms of Crohn's presentations like stricturing and fistulizing. Those with prior surgeries in the area or disease in other sites, as well as those with intraabdominal sepsis, cannot participate.Check my eligibility

What is being tested?

The study tests if removing more of the mesentery (the tissue that attaches intestines to the back wall of the abdomen) during first-time surgery can reduce disease recurrence at six months post-surgery in patients with Crohn's Disease.See study design

What are the potential side effects?

While not specified here, extended mesenteric excision may increase risks such as bleeding, infection, and potential complications related to bowel surgery.

Eligibility Criteria

Inclusion Criteria

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

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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.

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

Number of participants with endoscopic recurrence at 6 months

Secondary outcome measures

Number of participants with endoscopic recurrence at 18 months

Rates of post-operative complications compared between study groups

Rates of recurrence requiring surgery by 2 years

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention

Prospective study arm involving an extended mesenteric ileocolic excision.

Group II: Control ArmActive Control1 Intervention

Historical controls from a retrospective chart review of patients who had a limited ileocolic resection.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Montreal General HospitalLead Sponsor

17 Previous Clinical Trials

10,007 Total Patients Enrolled

Jewish General HospitalOTHER

137 Previous Clinical Trials

272,014 Total Patients Enrolled

Media Library

Extended Mesenteric Resection (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04539665 — N/A

Crohn's Disease Research Study Groups: Control Arm, Intervention Arm

Crohn's Disease Clinical Trial 2023: Extended Mesenteric Resection Highlights & Side Effects. Trial Name: NCT04539665 — N/A

Extended Mesenteric Resection (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04539665 — N/A

Frequently Asked Questions

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

How many individuals are eligible for enrollment in this trial?

"Affirmative. Clinicaltrials.gov shows that the trial, which was first made available on September 27th 2019 is still actively recruiting patients for its protocol. 30 participants need to be recruited from two different medical facilities."

Answered by AI