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

Recruiting

Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal Crohn's Disease: A Phase II Randomized Trial

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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: Participants in whom a stoma is required before randomization (identified intra-operatively) will not be randomized and will be excluded from the trial. Stoma after randomization: If a stoma is created after randomization-either during the index operation or at re-operation for postoperative complications-the participant remains in the trial. All feasibility, histopathology, operative, and safety outcomes will be collected and analyzed in the assigned arm (ITT). However, these participants will not be evaluable for the endoscopic-recurrence endpoint; they will be listed as "not assessed for endoscopic recurrence (stoma)" with reasons documented.
* Contraindication to IOUS (as determined by the surgeon).

About the study

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.

What is being tested

Sponsor: The Cleveland Clinic · Participants: 22 · Started: 2026-09

Contact the study team

Official record on ClinicalTrials.gov — NCT07680283

Locations in the U.S.

OhioCleveland Clinic, Cleveland

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.