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MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)
Sponsor: The Cleveland Clinic
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
high ligation of ileocolic artery
Patients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing
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