Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD
Purpose
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.
Condition
- Crohn's Disease (CD)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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).
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental IOUS-guided margin selection "Margin B" |
After the surgeon initially selects the macroscopic Margin A, IOUS will be performed to guide the selection of a proximal resection margin ("Margin B"). Margin B will be defined by specific IOUS criteria: mural thickness ≤ 2.5 mm and preserved stratification of the bowel wall. |
|
|
No Intervention Macroscopic margin selection "Margin A" |
The proximal transection site of the ileocecal resection will be chosen by the surgeon based on gross visual and tactile assessment of the bowel ("Margin A"). This represents the current standard of care. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- The Cleveland Clinic