Ultrasound-guided margin choice during ileocolic resection for Crohn's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase II, single-center randomized trial at the Cleveland Clinic comparing ultrasound-guided margin selection to standard macroscopic margin selection in patients undergoing primary ileocolic resection for terminal ileal Crohn's disease. Participants and outcome assessors are blinded to the treatment arm, while surgeons cannot be blinded due to the nature of the intervention. Randomization is computer-generated with concealed allocation to ensure balanced groups. The primary goal is to determine if ultrasound guidance improves surgical precision and outcomes compared with conventional margin selection. The study focuses on adults with Crohn's disease localized to the terminal ileum/ileocecal region and excludes those needing more complex resections or with pre-existing stomas at randomization.

Why it matters

Who can join: the full rules

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).

Where it's running

• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.