At-Home Bowel Stimulation

Recruiting now

Conditions studied: Post-Operative Ileus (POI)

In brief

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.

Key facts

Study ID

NCT07574437

Run by

The Cleveland Clinic

People needed

34

Starts

2025-10-28

Expected to finish

2026-07-07

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients who have undergone a partial colectomy or proctectomy for benign or malignant disease with a protective loop ileostomy

You may not qualify if…

• 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 is running

• Cleveland Clinic Florida — Weston, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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