Clinical Trial

At-Home Bowel Stimulation

Recruiting
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Record status
This record was last updated May 20, 2026 (before its estimated July 7, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-05.
Trial Details
NCT Number NCT07574437
Lead Sponsor The Cleveland Clinic
Conditions Post-Operative Ileus (POI)
Enrollment 34 participants
Start Date 2025-10-28
Primary Completion 2026-07-07 (estimated)
Study Completion 2026-07-07 (estimated)
Updated on ClinicalTrials.gov 2026-05-20