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Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal CD

Ultrasound-Guided Versus Standard Margin Selection in Ileocecal Resection of Terminal Ileal Crohn's Disease: A Phase II Randomized Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two ways to choose where to cut the bowel during surgery: using ultrasound images or looking at the bowel directly. It is for adults with Crohn’s disease at the end of the small bowel who are having their first surgery to remove that area and part of the colon.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have Crohn’s disease with swelling or scar-related narrowing limited to the end of the small bowel or where it joins the colon.
  • The affected area is confirmed by scans before surgery or by checking during surgery.
  • Plan to have a first surgery to remove the end of the small bowel and part of the colon.

Who can't join

  • Have disease that breaks through the bowel wall, with a pocket of pus or a complex abnormal tunnel that needs complex surgery.
  • Have already had surgery to remove the end of the small bowel and part of the colon.
  • Have Crohn’s disease in the colon.
  • Are pregnant or unable to give informed consent to join the study.
  • Have or need a stoma before being assigned to a study group. A stoma is an opening in the belly for bowel waste. If one is made after group assignment, you stay in the study, but cannot have the scope-based check for Crohn’s returning.
  • The surgeon decides that ultrasound during surgery is not suitable for you.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (1)

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