Individualized Non-pharmacological Intervention for Bowel Preparation
1. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Podmínky
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
339
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Xingshun Qi
- Telefonní číslo: +8618909881019
- E-mail: xingshunqi@126.com
Studijní záloha kontaktů
- Jméno: weiyi wang
- Telefonní číslo: 13019441021
- E-mail: 373302698@qq.com
Studijní místa
-
-
Liaoning
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Shenyang, Liaoning, Čína, 110016
- Nábor
- General Hospital of Northern Theater Command
-
Kontakt:
- Xingshun Qi
- Telefonní číslo: 13019441024
- E-mail: xingshunqi@126.com
-
Kontakt:
- E-mail: 373302698@qq.com
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Bowel preparation quality
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of bowel preparation-related adverse events
Časové okno: 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
|
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Polyp/adenoma detection rate
Časové okno: Assessed by the endoscopist during colonoscopy procedure
|
Assessed by the endoscopist during colonoscopy procedure
|
|
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Compliance of bowel preparation
Časové okno: 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)
Časové okno: Assessed during the waiting period prior to colonoscopy procedure
|
Patients are asked whether they are willing to undergo a repeat colonoscopy.
|
Assessed during the waiting period prior to colonoscopy procedure
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Studijní židle: Xingshun Qi, The General Hospital of Northern Theater Command
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
8. června 2026
Primární dokončení (Odhadovaný)
30. srpna 2026
Dokončení studie (Odhadovaný)
30. září 2026
Termíny zápisu do studia
První předloženo
26. června 2026
První předloženo, které splnilo kritéria kontroly kvality
1. července 2026
První zveřejněno (Aktuální)
6. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
6. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
1. července 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- XHNKKY-INPI-1.0
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Popis plánu IPD
The datasets analyzed during the current study are not publicly available due to ethical considerations.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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