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

Sponsor:

The Cleveland Clinic

Code:

NCT04578392

Conditions

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

high ligation of ileocolic artery

mesenteric sparing

Study Details

Brief 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

Conditions

Crohn Disease

Study ID

NCT04578392

Start date

Jul 28, 2020

Status verified date

Apr, 2022

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

181 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: high ligation of ileocolic artery

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

active comparator: mesenteric sparing for a primary ileocolic resection

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

Interventions

high ligation of ileocolic artery

Patients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing

mesenteric sparing

Patients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing

Primary outcome measure

Endoscopic recurrence based on Rutgeert scoring at the time of colonoscopy [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Allison Bayles, AA

216-444-0887 ibdstemcelltherapy@ccf.org

Alex VanDenBossche, BSN

216-445-3455 ibdstemcelltherapy@ccf.org

Locations

Cedars-Sinai Hospital System

Recruiting

Los Angeles, California, United States, 90048

Contacts

Gayane Ovsepyan

Gayane.Ovsepyan@cshs.org

Principal Investigator:

Phillip Fleshner, MD

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Aaron J. Dawes, MD, PhD

ajdawes@stanford.edu

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Allison Bayles, AA

216-444-0887 ibdstemcelltherapy@ccf.org

Principal Investigator:

Amy Lightner, MD

Mt. Sinai

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Principal Investigator:

Anthony de Buck van Overstraeten, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Apr 5, 2022

Last verified

Apr, 2022

Keywords

ileocolic resection
Crohn's disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2022-04-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.