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Recruiting No phase listed Observational

At-Home Bowel Stimulation

ClinicalTrials.gov ID: NCT07574437

Public ClinicalTrials.gov record NCT07574437. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 9:26 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

At-Home Bowel Stimulation: A Prospective Cohort Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07574437
Recruitment status
Recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
The Cleveland Clinic
Other
Enrollment
34 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 27, 2025
Primary completion
Jul 6, 2026
Completion
Jul 6, 2026
Last update posted
May 19, 2026

2025 – 2026

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Cleveland Clinic Florida Weston Florida 33331 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07574437, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 19, 2026 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07574437 live on ClinicalTrials.gov.

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