Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

At-Home Bowel Stimulation

18 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Estimé)

34

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Marylise Boutros, MD
  • Numéro de téléphone: 954-659-5278
  • E-mail: BOUTROM3@ccf.org

Lieux d'étude

  • États-Unis
    • Florida
      • Weston, Florida, États-Unis, 33331
        • Recrutement
        • Cleveland Clinic Florida
        • Chercheur principal:
          • Marylise Boutros, MD
        • Contact:
          • Marylise Boutros, MD
          • Numéro de téléphone: 954-659-5278
          • E-mail: BOUTROM3@ccf.org

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of participants who successfully completed at least 6 of the 9 at-home bowel stimulation sessions
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Return to normal bowel function
Délai: 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
Délai: 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.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
European Quality of Life 5 Dimension
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The Cleveland Clinic

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

28 octobre 2025

Achèvement primaire (Estimé)

7 juillet 2026

Achèvement de l'étude (Estimé)

7 juillet 2026

Dates d'inscription aux études

Première soumission

20 mars 2026

Première soumission répondant aux critères de contrôle qualité

5 mai 2026

Première publication (Réel)

8 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 mai 2026

Dernière vérification

1 mars 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 24-1049

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner