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At-Home Bowel Stimulation

18. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

34

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Marylise Boutros, MD
  • Telefonnummer: 954-659-5278
  • E-Mail: BOUTROM3@ccf.org

Studienorte

  • Vereinigte Staaten
    • Florida
      • Weston, Florida, Vereinigte Staaten, 33331
        • Rekrutierung
        • Cleveland Clinic Florida
        • Hauptermittler:
          • Marylise Boutros, MD
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of participants who successfully completed at least 6 of the 9 at-home bowel stimulation sessions
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Return to normal bowel function
Zeitfenster: 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
Zeitfenster: 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 Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
European Quality of Life 5 Dimension
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The Cleveland Clinic

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

28. Oktober 2025

Primärer Abschluss (Geschätzt)

7. Juli 2026

Studienabschluss (Geschätzt)

7. Juli 2026

Studienanmeldedaten

Zuerst eingereicht

20. März 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Mai 2026

Zuerst gepostet (Tatsächlich)

8. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Mai 2026

Zuletzt verifiziert

1. März 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 24-1049

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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