Clinical Trial

Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD

Study acronym: SMILE-CD
Recruiting
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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.
Trial Details
NCT Number NCT07680283
Lead Sponsor The Cleveland Clinic
Conditions Crohn's Disease (CD)
Enrollment 44 participants
Start Date 2026-07
Primary Completion 2028-06 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-02