Individualized Non-pharmacological Intervention for Bowel Preparation
1 juillet 2026 mis à jour par: Xingshun Qi, General Hospital of Shenyang Military Region
Effect of an Individualized Non-pharmacological Intervention Based on a Predictive Model for Inadequate Bowel Preparation on Bowel Preparation Quality: a Three-arm, Prospective, Randomized Controlled Study
Colonoscopy is essential for the early detection of colorectal cancer.
However, inadequate bowel preparation remains a common challenge, associated with reduced adenoma detection rates, prolonged procedure time, and increased healthcare costs.
Current individualized regimens rely largely on higher laxative dosages-an approach with limited clinical utility.
Non-pharmacological interventions, including dietary modification, physical activity, and health education, are safe and tend to have better patient adherence.
The effectiveness of health education depends largely on message framing.
Guided by information-framing theory, we developed an individualized non-pharmacological regimen.
This randomized controlled trial aims to evaluate the efficacy of this regimen in improving bowel preparation quality.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
A total of 339 patients are enrolled and randomly assigned in a 1:1:1 ratio to the information-framing + individualized bowel preparation (BP) group, the individualized BP group, and the control group.
All patients receive oral instructions on bowel preparation.
On this basis, the control group receives a standard BP regimen and written educational materials; the individualized BP group is assessed using a risk prediction model for inadequate bowel preparation, with the results disclosed to the patients.
Those with a risk score ≥3.25 receive an enhanced BP regimen, while those with a risk score <3.25 receive the standard BP regimen, and all patients in this group receive illustrated educational materials.
In the information-framing + individualized BP group, educational materials are further tailored according to the information framework theory.
Specifically, patients with a risk score ≥3.25 receive loss-framed materials emphasizing the harms of non-adherence, whereas those with a score <3.25 receive gain-framed materials highlighting the benefits of adherence.
On the day of the colonoscopy, patients' willingness to undergo a repeat colonoscopy and the occurrence of adverse events are recorded in the waiting area.
Patients also complete the Bowel Preparation Adherence Behavior Assessment Scale and the Treatment Self-Regulation Questionnaire.
Bowel preparation quality is evaluated by endoscopists blinded to group allocation using the Boston Bowel Preparation Scale (BBPS), and polyp/adenoma detection rates are also recorded.
Type d'étude
Interventionnel
Inscription (Estimé)
339
Phase
- N'est pas applicable
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: Xingshun Qi
- Numéro de téléphone: +8618909881019
- E-mail: xingshunqi@126.com
Sauvegarde des contacts de l'étude
- Nom: weiyi wang
- Numéro de téléphone: 13019441021
- E-mail: 373302698@qq.com
Lieux d'étude
-
-
Liaoning
-
Shenyang, Liaoning, Chine, 110016
- Recrutement
- General Hospital of Northern Theater Command
-
Contact:
- Xingshun Qi
- Numéro de téléphone: 13019441024
- E-mail: xingshunqi@126.com
-
Contact:
- E-mail: 373302698@qq.com
-
-
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
La description
Inclusion Criteria:
- age ≥ 18 years;
- outpatient scheduled for colonoscopy using oral laxatives for bowel preparation;
- able to understand the study and provide written informed consent.
Exclusion Criteria:
- undergoing emergency colonoscopy;
- suspected intestinal obstruction, stricture, or perforation;
- severe cardiac, cerebral, hepatic, or renal disease;
- severe psychiatric disorder;
- impaired consciousness or communication difficulties;
- pregnancy or lactation;
- previous enrollment in this study.
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
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Standard bowel preparation group
Patients receive verbal instructions and printed text-based bowel preparation education materials, along with a standard bowel preparation regimen.
|
Patients receive verbal bowel preparation instruction and printed text-based bowel preparation education materials.
|
|
Expérimental: Individualized bowel preparation group
Patients receive verbal instructions and printed illustrated bowel preparation educational materials.
The inadequate bowel preparation risk score is calculated using the established prediction model.
Patients with a risk score ≥ 3.25 receive an enhanced bowel preparation regimen, whereas those with a score < 3.25 receive the standard bowel preparation regimen.
The enhanced bowel preparation regimen is based on the standard protocol, with two additional components.
First, starting 3 days before the colonoscopy, patients are instructed to avoid high-fiber foods and, from 1 day before the colonoscopy, to adopt a semiliquid low-residue diet.
They are also asked to walk for 30 minutes after each meal, with a target of approximately 6,000 steps per day.
Second, after consuming each 500 mL of the polyethylene glycol electrolyte solution and upon finishing the entire solution, patients are asked to chew one piece of sugar-free gum for 10 minutes.
|
Patients receive verbal instructions and printed illustrated bowel preparation educational material.
Patients with a risk score ≥ 3.25 are instructed to take low-residue diet 3 days before colonoscopy and walk for 30 minutes after each meal, with a target of approximately 6,000 steps per day.
After consuming each 500 mL of polyethylene glycol electrolyte solution, and finishing the entire solution, patients are asked to chew one piece of sugar-free gum for 10 minutes.
Patients with a score < 3.25 received the standard bowel preparation regimen.
|
|
Expérimental: Information-framing guided individualized bowel preparation group
Patients receive the same interventions as those in the individualized group.
In addition, they receive information-framed educationa material.
For those with an inadequate bowel preparation risk score ≥ 3.25, negatively-framed materials emphasizing the harms of non-adherence are provided; for those with a score < 3.25, positively-framed materials emphasizing the benefits of adherence are provided.
|
Patients receive verbal instructions and printed illustrated bowel preparation educational material.
Patients with a risk score ≥ 3.25 are instructed to take low-residue diet 3 days before colonoscopy and walk for 30 minutes after each meal, with a target of approximately 6,000 steps per day.
After consuming each 500 mL of polyethylene glycol electrolyte solution, and finishing the entire solution, patients are asked to chew one piece of sugar-free gum for 10 minutes.
Patients with a score < 3.25 received the standard bowel preparation regimen.
For those with an inadequate bowel preparation risk score ≥ 3.25, negatively-framed materials emphasizing the harms of non-adherence are provided; for those with a score < 3.25, positively-framed materials emphasizing the benefits of adherence are provided.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Bowel preparation quality
Délai: Assessed by the endoscopist during colonoscopy procedure
|
Bowel preparation quality is assessed using the Boston Bowel Preparation Scale (BBPS).
Bowel preparation was considered adequate when the total BBPS score was ≥ 6, with each colonic segment score ≥ 2.
|
Assessed by the endoscopist during colonoscopy procedure
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of bowel preparation-related adverse events
Délai: Recorded during the waiting period prior to colonoscopy procedure
|
Incidence of nausea, vomiting, abdominal distension, abdominal pain
|
Recorded during the waiting period prior to colonoscopy procedure
|
|
Polyp/adenoma detection rate
Délai: Assessed by the endoscopist during colonoscopy procedure
|
Assessed by the endoscopist during colonoscopy procedure
|
|
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Compliance of bowel preparation
Délai: Assessed during the waiting period prior to colonoscopy procedure
|
Compliance of bowel preparation is assessed by Bowel Preparation Adherence Behavior Assessment Scale.
The Bowel Preparation Adherence Behavior Assessment Scale has a total score ranging from 12 to 60, with higher scores indicating better adherence.
|
Assessed during the waiting period prior to colonoscopy procedure
|
|
Willingness to undergo colonoscopy again (yes/no)
Délai: Assessed during the waiting period prior to colonoscopy procedure
|
Patients are asked whether they are willing to undergo a repeat colonoscopy.
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Assessed during the waiting period prior to colonoscopy procedure
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chaise d'étude: Xingshun Qi, The General Hospital of Northern Theater Command
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)
8 juin 2026
Achèvement primaire (Estimé)
30 août 2026
Achèvement de l'étude (Estimé)
30 septembre 2026
Dates d'inscription aux études
Première soumission
26 juin 2026
Première soumission répondant aux critères de contrôle qualité
1 juillet 2026
Première publication (Réel)
6 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 juillet 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- XHNKKY-INPI-1.0
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
The datasets analyzed during the current study are not publicly available due to ethical considerations.
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
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