The Cleveland Clinic
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.
Inclusion Criteria: * Adults aged ≥18 years. * Diagnosis of terminal ileal Crohn's disease with inflammatory or fibrostenotic phenotype localized to terminal ileum/ileocecal region and assessed on either preoperative imaging or during surgical exploration at the time of surgery. * Scheduled to undergo primary ileocolic resection. Exclusion Criteria: * Penetrating disease with abscess or complex fistula requiring complex resection. * Prior ileocolic resection. * Diagnosis of Crohn's colitis. * Pregnancy or inability to provide informed consent. * Stoma at or before randomization: Participant…
Intra-operative ultrasound (IOUS)-guided proximal resection margin selection during ileocolic resection for terminal ileal Crohn's disease
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