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NCT07574437 · ClinicalTrials.gov registry record
At-Home Bowel Stimulation
A clinical trial, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- 34
- Enrollment target
NCT07574437 is a clinical trial that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 34 participants.
The verdict
NCT07574437 is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- 34 participants
- Enrollment target
Study Summary
Postoperative ileus (POI) is a common complication after ileostomy closure and is associated with patient discomfort, delayed return of bowel function, prolonged hospital stay, and increased healthcare costs. One proposed contributor to POI is prolonged inactivity of the bowel segment distal to the ileostomy prior to restoration of intestinal continuity. Previous studies, including a multicenter randomized controlled trial, have shown that preoperative bowel stimulation of the defunctionalized intestine can reduce rates of POI and shorten length of hospital stay. However, these interventions were performed in outpatient or hospital settings and required specialized nursing support. This single-center, prospective interventional study aims to evaluate the feasibility and clinical impact of a patient-performed, at-home bowel stimulation program prior to ileostomy closure. Participants will perform daily bowel stimulation sessions at home for 3 weeks before surgery, following an initial supervised session. The primary objective is to assess feasibility, defined as successful completion of at least 6 of 9 at-home stimulation sessions by more than 75% of participants. Secondary outcomes include return to normal bowel function and length of hospital stay. Exploratory outcomes include postoperative bowel function, quality of life, and patient satisfaction. Study outcomes will be compared with a retrospective cohort of patients who previously underwent ileostomy closure without at-home bowel stimulation. The long-term goal of this research is to support incorporation of preoperative bowel stimulation into Enhanced Recovery After Surgery (ERAS®) pathways for patients undergoing ileostomy closure.
Interventions
- OTHER At-home bowel stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2025-10-28 |
| Est. Completion | 2026-07-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07574437
The ClinicalTrials.gov registry entry for NCT07574437 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which At-home bowel stimulation is the first listed.
NCT07574437 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07574437 about?
NCT07574437 is a clinical study titled "At-Home Bowel Stimulation". Postoperative ileus (POI) is a common complication after ileostomy closure and is associated with patient discomfort, delayed return of bowel function, prolonged hospital stay, and increased healthcare costs. One proposed contributor to POI is prolonged inactivity of the bowel segment distal to the ...
What is the current status of trial NCT07574437?
This trial is currently recruiting. The enrollment target is 34 participants. The study started on 2025-10-28. Estimated completion is 2026-07-07.
What interventions are being tested in trial NCT07574437?
The interventions under investigation include: At-home bowel stimulation (OTHER).
Who is sponsoring clinical trial NCT07574437?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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