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RECRUITING
NCT04578392
NA

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

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

181

Start Date

2020-07-28

Completion Date

2027-12-31

Last Updated

2022-04-05

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

high ligation of ileocolic artery

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

PROCEDURE

mesenteric 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