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

Stopped early · Not applicable

Conditions studied: Crohn Disease

In brief

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 facts

Study ID

NCT04578392

Run by

The Cleveland Clinic

People needed

13

Starts

2020-07-28

Expected to finish

2023-12-31

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females 18-65 years of age.
• Isolated ileocolic Crohn's disease of <30 cm in length
• Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, vedolizumab, ustekinumab therapy are permitted.
• Ability to comply with protocol
• Competent and able to provide written informed consent
• Medically refractory disease or inability to tolerate ongoing medical therapy
• Exclusion Criteria:Inability to give informed consent.
• Patients less than 18 years of age
• Patients undergoing repeat ileocolic resection
• Patients with concurrent disease in other locations (e.g. proximal stricturing of the small bowel, fistulizing disease to the sigmoid colon) requiring an additional intervention in the operating room beyond an ileocolic resection.
• Patients with >30 cm of terminal ileal disease
• Patients who are undergoing an ileal resection only (NOT ileocecal) because the disease spares the distal most aspect of ileum and ileocecal valve
• Patient whose anastomosis is diverted intra-operatively with a loop or end ileostomy
• Clinically significant medical conditions within the six months before surgery: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
• Specific exclusions; Evidence of hepatitis B, C, or HIV
• History of cancer including melanoma (with the exception of localized skin cancers)
• Emergent indication for an operation
• Pregnant or breast feeding.
• History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity
• Inability to follow up at respective sites for the primary endpoint

Where it is running

• 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

Full record on ClinicalTrials.gov

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