Individualized Non-pharmacological Intervention for Bowel Preparation
1 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
339
Fase
- Non applicabile
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: Xingshun Qi
- Numero di telefono: +8618909881019
- Email: xingshunqi@126.com
Backup dei contatti dello studio
- Nome: weiyi wang
- Numero di telefono: 13019441021
- Email: 373302698@qq.com
Luoghi di studio
-
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Liaoning
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Shenyang, Liaoning, Cina, 110016
- Reclutamento
- General Hospital of Northern Theater Command
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Contatto:
- Xingshun Qi
- Numero di telefono: 13019441024
- Email: xingshunqi@126.com
-
Contatto:
- Email: 373302698@qq.com
-
-
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
Descrizione
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.
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
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Standard bowel preparation group
Patients receive verbal instructions and printed text-based bowel preparation education materials, along with a standard bowel preparation regimen.
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Patients receive verbal bowel preparation instruction and printed text-based bowel preparation education materials.
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Sperimentale: 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.
|
|
Sperimentale: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Bowel preparation quality
Lasso di tempo: Assessed by the endoscopist during colonoscopy procedure
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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.
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Assessed by the endoscopist during colonoscopy procedure
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of bowel preparation-related adverse events
Lasso di tempo: Recorded during the waiting period prior to colonoscopy procedure
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Incidence of nausea, vomiting, abdominal distension, abdominal pain
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Recorded during the waiting period prior to colonoscopy procedure
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Polyp/adenoma detection rate
Lasso di tempo: Assessed by the endoscopist during colonoscopy procedure
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Assessed by the endoscopist during colonoscopy procedure
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Compliance of bowel preparation
Lasso di tempo: Assessed during the waiting period prior to colonoscopy procedure
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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.
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Assessed during the waiting period prior to colonoscopy procedure
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Willingness to undergo colonoscopy again (yes/no)
Lasso di tempo: 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
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Cattedra di studio: Xingshun Qi, The General Hospital of Northern Theater Command
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)
8 giugno 2026
Completamento primario (Stimato)
30 agosto 2026
Completamento dello studio (Stimato)
30 settembre 2026
Date di iscrizione allo studio
Primo inviato
26 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 luglio 2026
Primo Inserito (Effettivo)
6 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
6 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 luglio 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- XHNKKY-INPI-1.0
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
The datasets analyzed during the current study are not publicly available due to ethical considerations.
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 .