Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD
Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal Crohn's Disease: A Phase II Randomized Trial
The Cleveland Clinic
44 participants
Jul 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Intra-operative ultrasound (IOUS)-guided proximal resection margin selection during ileocolic resection for terminal ileal Crohn's disease
Locations(1)
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NCT07680283