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At-Home Bowel Stimulation

18 mei 2026 bijgewerkt door: The Cleveland Clinic

At-Home Bowel Stimulation: A Prospective Cohort Study

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Observationeel

Inschrijving (Geschat)

34

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Marylise Boutros, MD
  • Telefoonnummer: 954-659-5278
  • E-mail: BOUTROM3@ccf.org

Studie Locaties

  • Verenigde Staten
    • Florida
      • Weston, Florida, Verenigde Staten, 33331
        • Werving
        • Cleveland Clinic Florida
        • Hoofdonderzoeker:
          • Marylise Boutros, MD
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Ander: At-home bowel stimulation
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.
Retrospective cohort
This cohort will consist of patients who previously underwent ileostomy closure at Cleveland Clinic Florida without the at-home bowel stimulation intervention.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Return to normal bowel function
Tijdsspanne: 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.
From postoperative day 0 (ileostomy closure date) until return of normal bowel function, assessed daily during the index hospitalization, up to 30 days postoperatively.
Length of stay
Tijdsspanne: 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
From postoperative day 0 (ileostomy closure date) until hospital discharge, assessed during the index hospitalization, up to 30 days postoperatively.

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
European Quality of Life 5 Dimension
Tijdsspanne: 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.
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
Tijdsspanne: 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
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)
Global Physical Health (GPH) as measured by Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)
Tijdsspanne: 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.
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 Mental Health (GMH) as measured by Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10)
Tijdsspanne: 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.
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).
Bowel function
Tijdsspanne: 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).
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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The Cleveland Clinic

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

28 oktober 2025

Primaire voltooiing (Geschat)

7 juli 2026

Studie voltooiing (Geschat)

7 juli 2026

Studieregistratiedata

Eerst ingediend

20 maart 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 mei 2026

Eerst geplaatst (Werkelijk)

8 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

18 mei 2026

Laatst geverifieerd

1 maart 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 24-1049

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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