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Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD
Sponsor: The Cleveland Clinic
Summary
This is a Phase II, single-center (Cleveland Clinic), two-arm, randomized, parallel-group superiority trial. The two arms will compare IOUS-guided margin selection against standard macroscopic margin selection in patients undergoing ileocolic resection for terminal ileal Crohn's disease. Patients and outcome assessors (pathologists, endoscopists) will be blinded to the intervention arm, while surgeons, by the nature of the intervention, cannot be blinded. Randomization will be computer-generated with concealed allocation using permuted blocks to ensure balanced group sizes.
Official title: Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal Crohn's Disease: A Phase II Randomized Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2026-07
Completion Date
2029-01
Last Updated
2026-07-02
Healthy Volunteers
No
Conditions
Interventions
IOUS-guided margin selection
Intra-operative ultrasound (IOUS)-guided proximal resection margin selection during ileocolic resection for terminal ileal Crohn's disease
Locations (1)
Cleveland Clinic
Cleveland, Ohio, United States