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NCT Number: NCT07574437

At-Home Bowel Stimulation

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.

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Key information

Conditions

Post-Operative Ileus (POI)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location status: Recruiting

Location contact

Marylise Boutros, MD

CONTACT

[email protected]

954-659-5278

Marylise Boutros, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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)

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

Secondary outcomes

  1. Return to normal bowel function

    Time frame: From postoperative day 0 (ileostomy closure date) until return of normal bowel function, assessed daily during the index hospitalization, up to 30 days postoperatively.

    Normal bowel function will be defined as the absence of postoperative ileus. Postoperative ileus is defined as intolerance of oral intake, in the absence of clinical or radiographic evidence of obstruction, that either (a) requires nasogastric tube insertion or (b) is accompanied by at least two of the following on or after postoperative day 3: nausea or vomiting, abdominal distension, and absence of flatus.

  2. Length of stay

    Time frame: From postoperative day 0 (ileostomy closure date) until hospital discharge, assessed during the index hospitalization, up to 30 days postoperatively.

    Length of hospital stay after ileostomy closure

Other outcomes

  1. Bowel function

    Time frame: From postoperative day 0 through hospital discharge during the index hospitalization; postoperative weeks 1, 2, 3, and 4; and postoperative months 3 and 6 following ileostomy closure.

    Post-operative bowel dysfunction will be assessed using the Low Anterior Resection Syndrome (LARS) score in rectal cancer patients only.

    The LARS score has a minimum value of 0 and a maximum value of 42 and higher scores mean worse outcome (no LARS: 0-20, minor LARS: 21-29, and major LARS: 30-42).

  2. European Quality of Life 5 Dimension

    Time frame: 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).

    Quality of life will be measure by the European Quality of Life 5 Dimension (EQ-5D).

    The EQ-5D has two separate components:

    • EQ-5D health state index / utility score: Minimum is usually below 0 and maximum is 1.0. 1.0 = full health. Negative values mean a health state considered worse than death. Exact minimum depends on the country/value set used.
    • EQ visual analogue scale (VAS): Minimum 0, maximum 100. 0 = worst imaginable health, 100 = best imaginable health.

  3. Patient satisfaction

    Time frame: 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)

    A satisfaction survey will be administered to participants

  4. Global Physical Health (GPH) as measured by Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)

    Time frame: Global Physical Health (GPH) will be assessed at 4 weeks, as well as at 3 and 6 months following operative day (i.e., ileostomy closure date - day 0).

    Global Physical Health (GPH) will be assessed using the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10). Scores are converted to T-scores standardized to a mean of 50 and standard deviation of 10 in the general population. Higher scores indicate better physical health.

  5. Global Mental Health (GMH) as measured by Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)

    Time frame: Global Mental Health (GMH) will be assessed at 4 weeks, as well as at 3 and 6 months following operative day (i.e., ileostomy closure date - day 0).

    Global Mental Health (GMH) will be assessed using the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10). Scores are converted to T-scores standardized to a mean of 50 and standard deviation of 10 in the general population. Higher scores indicate better mental health.

Study contacts

Contact information is provided by the study sponsor or research team.

Marylise Boutros, MD

CONTACT

[email protected]

954-659-5278

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

At-Home Bowel Stimulation: A Prospective Cohort Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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