Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD (NCT07680283)
Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal Crohn's Disease: A Phase II Randomized Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (7 items).
Location: Cleveland Clinic — Cleveland, Ohio
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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).
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Cleveland Clinic — Cleveland, Ohio
📞 Contact the Study Coordinator
Phone: (216) 445-6570
Email: BRANCHM2@ccf.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Crohn's Disease (CD)
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- Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD) — Chapel Hill, North Carolina
- Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD) — Chandler, Arizona
Explore by condition: All Crohn's Disease (CD) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.