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

NCT04578392 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-04-16

No results posted yet for this study

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

Interventions

PROCEDURE

high ligation of ileocolic artery

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

PROCEDURE

mesenteric sparing

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

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Amy Lightner, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-28
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United States
  • Canada
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04578392 on ClinicalTrials.gov