RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2020-07-28
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04578392

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females 18-65 years of age.
  2. * Isolated ileocolic Crohn's disease of \<30 cm in length
  3. * Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, vedolizumab, ustekinumab therapy are permitted.
  4. * Ability to comply with protocol
  5. * Competent and able to provide written informed consent
  6. * Medically refractory disease or inability to tolerate ongoing medical therapy
  1. * Patients less than 18 years of age
  2. * Patients undergoing repeat ileocolic resection
  3. * 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.
  4. * Patients with \>30 cm of terminal ileal disease
  5. * Patients who are undergoing an ileal resection only (NOT ileocecal) because the disease spares the distal most aspect of ileum and ileocecal valve
  6. * Patient whose anastomosis is diverted intra-operatively with a loop or end ileostomy
  7. * 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.
  8. * Specific exclusions; Evidence of hepatitis B, C, or HIV
  9. * History of cancer including melanoma (with the exception of localized skin cancers)
  10. * Emergent indication for an operation
  11. * Pregnant or breast feeding.
  12. * History of clinically significant auto-immunity (other than Crohn's disease) or any previous example of fat-directed autoimmunity
  13. * Inability to follow up at respective sites for the primary endpoint

Contacts and Locations

Study Contact

Allison Bayles, AA
CONTACT
216-444-0887
ibdstemcelltherapy@ccf.org
Alex VanDenBossche, BSN
CONTACT
216-445-3455
ibdstemcelltherapy@ccf.org

Principal Investigator

Amy Lightner, MD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cedars-Sinai Hospital System
Los Angeles, California, 90048
United States
Stanford University School of Medicine
Stanford, California, 94305
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Amy Lightner, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-28
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2020-07-28
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • ileocolic resection
  • Crohn's disease

Additional Relevant MeSH Terms

  • Crohn Disease