Trial Search Results

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.

Lead Sponsor:

The Cleveland Clinic

Intervention(s):

  • Procedure: high ligation of ileocolic artery
  • Procedure: mesenteric sparing

Phase:

N/A

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
Recruiting