At-Home Bowel Stimulation

Conditions

• Post-Operative Ileus (POI)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• At-home bowel stimulation — OTHER
  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.

Study Details

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 Dates

Start date

Oct 28, 2025

Status verified

Mar 2026

Primary completion

Jul 7, 2026

Completion

Jul 7, 2026

Study Design

Enrollment

34 participants (estimated)

Arms

• Arm: Prospective cohort
  The prospective cohort will consist of 34 adult patients undergoing elective ileostomy closure at Cleveland Clinic Florida. Participants will complete 10 bowel stimulations within 3 weeks prior to ileostomy closure.
• Arm: Retrospective cohort
  This cohort will consist of patients who previously underwent ileostomy closure at Cleveland Clinic Florida without the at-home bowel stimulation intervention.

Primary Outcome Measure

Percentage of participants who successfully completed at least 6 of the 9 at-home bowel stimulation sessions [ Time Frame: Within 3 weeks prior to operative day (i.e., ileostomy closure date - day 0) ]

Central Contacts

• Marylise Boutros, MD
  954-659-5278
  [email protected]

Locations (1)

Find similar trials in Weston, FL