Education and Training
MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)
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
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- procedure: high ligation of ileocolic artery
- procedure: mesenteric sparing
Eligibility
Inclusion Criteria:
- 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
Ages Eligible for Study
18 Years - 65 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Aaron J. Dawes, MD, PhD
I'm interested