MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)
The Cleveland Clinic
181 participants
Jul 28, 2020
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
Inclusion Criteria6
- 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 Criteria13
- 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
Interventions
Patients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing
Patients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT04578392