Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IOUS-guided margin selection.
- Who it may be relevant to
- Registry conditions: Crohn's Disease (CD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal Crohn's Disease: A Phase II Randomized Trial
Overview
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.
Interventions
- Device IOUS-guided margin selection
Intra-operative ultrasound (IOUS)-guided proximal resection margin selection during ileocolic resection for terminal ileal Crohn's disease
Primary outcome measures
- feasibility in ultrasound assessment of resection margin [Time frame: Intraoperative / day of surgery]
Secondary outcome measures (1)
- Comparison of histologic inflammation within the IOUS arm at 6 to 12 months [Time frame: 6 to 12 months]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Cleveland Clinic — Cleveland
Identifiers
NCT: NCT07680283 · 26-491