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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

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

ArmDescriptionAssigned 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.
  • Device: IOUS-guided margin selection
    Intra-operative ultrasound (IOUS)-guided proximal resection margin selection during ileocolic resection for terminal ileal Crohn's disease
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

Cleveland Clinic
Cleveland, Ohio 44195
Contact:
Monica Branche
216-445-6570
BRANCHM2@ccf.org

More Details

Status
Recruiting
Sponsor
The Cleveland Clinic

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.