At-Home Bowel Stimulation

NCT07574437 | Recruiting DMC

• 1 other identifier: 24-1049
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Post-operative ileus; Bowel stimulation

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who successfully completed at least 6 of the 9 at-home bowel stimulation sessions

  75% of enrolled participants successfully completing at least 6 of the 9 at-home bowel stimulation sessions

  Within 3 weeks prior to operative day (i.e., ileostomy closure date - day 0)

Secondary Outcomes (2)

• Return to normal bowel function

  From operative day (i.e., ileostomy closure date - day 0)

• Length of stay

  From operative day (i.e., ileostomy closure date - day 0)

Other Outcomes (5)

• Bowel function

  Bowel function will be assessed at hospital discharge and at 1, 2, 3, and 4 weeks, as well as at 3 and 6 months following operative day (i.e., ileostomy closure date - day 0).

• European Quality of Life 5 Dimension

  Quality of life will be assessed at 4 weeks, as well as at 3 and 6 months following operative day (i.e., ileostomy closure date - day 0).

• Patient satisfaction

  Patient satisfaction will be assessed at 4 weeks, as well as at 3 and 6 months following operative day (i.e., ileostomy closure date - day 0)

Study Arms (2)

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.

Other: At-home bowel stimulation

Retrospective cohort

This cohort will consist of patients who previously underwent ileostomy closure at Cleveland Clinic Florida without the at-home bowel stimulation intervention.

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.

Prospective cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

RECRUITING

Central Study Contacts

Marylise Boutros, MD

CONTACT

954-659-5278; BOUTROM3@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: May 8, 2026
• Study Start: October 28, 2025
• Primary Completion (Estimated): July 7, 2026
• Study Completion (Estimated): July 7, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)