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

Description

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

Conditions

Crohn Disease

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Crohn Disease
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Hospital System, Los Angeles, California, United States, 90048

Stanford

Stanford University School of Medicine, Stanford, California, United States, 94305

Weston

Cleveland Clinic Florida, Weston, Florida, United States, 33331

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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 to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Amy Lightner, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2027-12-31