At-home bowel stimulation before ileostomy closure
Official title: At-Home Bowel Stimulation: A Prospective Cohort Study
Run by The Cleveland Clinic · NCT07574437 · Data updated 2026-11-12
This study tests whether people with a protective loop ileostomy can do daily at-home bowel stimulation for three weeks before closure to lower their chance of postoperative ileus.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Weston, Florida) |
| Status | Recruiting |
| Started | October 28, 2025 |
| Main results expected | July 7, 2027 |
| Study ends | July 7, 2027 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07574437 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a protective loop ileostomy after partial colectomy or proctectomy who are scheduled for elective closure, can speak English or Spanish, provide informed consent, and can perform daily home stimulation are ideal candidates.
✕Probably not a fit
Patients with inflammatory bowel disease, known peritoneal metastases, prior subtotal colectomy or total proctocolectomy, a planned laparotomy for closure, or inability to consent or perform the protocol are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, prospective interventional study trains patients with a protective loop ileostomy to perform daily at-home bowel stimulation sessions for three weeks before ileostomy closure following an initial in-person training. The study will track feasibility, adherence, safety, and clinical outcomes including rates of postoperative ileus and hospital length of stay. The protocol adapts previously studied bowel stimulation methods that were delivered by nursing staff in clinic or hospital settings for patient-performed home use. Researchers will compare outcomes around the time of ileostomy closure to determine whether the at-home approach is practical and clinically useful.
Why it matters
Potential benefit: If successful, at-home stimulation could reduce postoperative ileus rates and shorten hospital stays after ileostomy closure while reducing the need for specialized nursing support.
How similar studies have gone: Previous studies, including a multicenter randomized trial, showed that preoperative bowel stimulation delivered by nursing staff reduced postoperative ileus and shortened hospital stay, but patient-performed at-home stimulation has not been widely tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Adult patients who have undergone a partial colectomy or proctectomy for benign or malignant disease with a protective loop ileostomy Exclusion Criteria: * Underlying inflammatory bowel disease (IBD) * Known peritoneal metastases at the time of ileostomy closure * Inability to provide clear and informed consent * History of subtotal colectomy or total proctocolectomy * Planned laparotomy for ileostomy closure * Inability to speak English or Spanish
Where it's running
-
Cleveland Clinic Florida
Weston, Florida, United States Recruiting
Study contacts
- Study coordinator: Marylise Boutros, MD
- Email: BOUTROM3@ccf.org
- Phone: 954-659-5278
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.