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At-Home Bowel Stimulation

18 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Osservativo

Iscrizione (Stimato)

34

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Marylise Boutros, MD
  • Numero di telefono: 954-659-5278
  • Email: BOUTROM3@ccf.org

Luoghi di studio

  • Stati Uniti
    • Florida
      • Weston, Florida, Stati Uniti, 33331
        • Reclutamento
        • Cleveland Clinic Florida
        • Investigatore principale:
          • Marylise Boutros, MD
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of participants who successfully completed at least 6 of the 9 at-home bowel stimulation sessions
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Return to normal bowel function
Lasso di tempo: 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
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
European Quality of Life 5 Dimension
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Cleveland Clinic

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

28 ottobre 2025

Completamento primario (Stimato)

7 luglio 2026

Completamento dello studio (Stimato)

7 luglio 2026

Date di iscrizione allo studio

Primo inviato

20 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

8 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 maggio 2026

Ultimo verificato

1 marzo 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 24-1049

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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