RecruitingNot ApplicableNCT04578392

MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)


Sponsor

The Cleveland Clinic

Enrollment

181 participants

Start Date

Jul 28, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Study description - Patients will be randomized according to post-operative recurrence risk to either a high ligation of ileocolic artery or mesenteric sparing ileocolic resection for terminal ileal Crohn's disease. The primary endpoint 6-month endoscopic recurrence. Endpoints - Primary endpoint; 6 months Secondary endpoints at 1 and 5 years post ileocecal resection Study population - Adult Crohn's disease patients with medically refractory terminal ileal Crohn's disease undergoing a primary ileocecal resection. Study sites - Multicenter international study Description of study intervention - Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection Participate duration - 5 years


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study compares two surgical techniques for removing part of the bowel (ileocolic resection) in people with Crohn's disease: one that preserves the blood vessels feeding the intestine (mesenteric-sparing) versus the standard technique that ties off higher blood vessels (high ligation). The goal is to see which approach better prevents the disease from coming back. **You may be eligible if...** - You are 18–65 years old - You have Crohn's disease limited to the area where the small and large intestines connect (ileocolic), with affected segment less than 30 cm - Your disease has not responded to medications, or you cannot tolerate continued treatment - You have not had a previous ileocolic resection **You may NOT be eligible if...** - You have Crohn's disease in multiple locations requiring additional surgery beyond ileocolic resection - You have had a prior ileocolic resection - You have had a recent serious health event (heart attack, active angina, or heart failure within 6 months) - You have hepatitis B, C, or HIV - You have had or currently have cancer (except localized skin cancer) - You are pregnant or breastfeeding - You have a history of significant autoimmune conditions other than Crohn's Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREhigh ligation of ileocolic artery

Patients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing

PROCEDUREmesenteric sparing

Patients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing


Locations(7)

Cedars-Sinai Hospital System

Los Angeles, California, United States

Stanford University School of Medicine

Stanford, California, United States

Cleveland Clinic Florida

Weston, Florida, United States

Cleveland Clinic

Cleveland, Ohio, United States

Mt. Sinai

Toronto, Ontario, Canada

Humanitas

Rozzano, Milano, Italy

St Mark's Hospital and Academic Institution

Harrow, Middlesex, United Kingdom

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NCT04578392


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