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At-Home Bowel Stimulation

NCT07574437 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 34

Last updated 2026-05-20

No results posted yet for this 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.

Conditions

  • Post-Operative Ileus (POI)

Interventions

OTHER

At-home bowel stimulation

All participants will undergo a standardized preoperative bowel stimulation protocol prior to ileostomy closure. The intervention includes a total of 10 stimulation sessions performed over approximately three weeks. An initial in-person visit (≤30 minutes) with a trained research nurse will include placement of a catheter into the efferent limb of the ileostomy and performance of the first supervised stimulation as instruction. Each stimulation consists of instilling 500 mL of a thickened saline solution through the catheter using a syringe. Participants will then complete nine additional stimulations at home during the two weeks prior to surgery on weekdays only. Nursing phone support will be available during business hours, and weekday check-in calls will confirm completion. Participants will receive written instructions and a log to record session details, including symptoms and bowel movements. In-office stimulation will be available if needed.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2026-07-07
Completion
2026-07-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07574437 on ClinicalTrials.gov