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Individualized Non-pharmacological Intervention for Bowel Preparation

1. juli 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

339

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Liaoning
      • Shenyang, Liaoning, Kina, 110016

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard bowel preparation group
Patients receive verbal instructions and printed text-based bowel preparation education materials, along with a standard bowel preparation regimen.
Andet: Standard bowel preparation guidance
Patients receive verbal bowel preparation instruction and printed text-based bowel preparation education materials.
Eksperimentel: 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.
Andet: Individualized bowel preparation regimen
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.
Eksperimentel: 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.
Andet: Individualized bowel preparation regimen
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.
Andet: Information-framing guidance
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bowel preparation quality
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of bowel preparation-related adverse events
Tidsramme: 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
Tidsramme: Assessed by the endoscopist during colonoscopy procedure
Assessed by the endoscopist during colonoscopy procedure
Compliance of bowel preparation
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

General Hospital of Shenyang Military Region

Efterforskere

  • Studiestol: Xingshun Qi, The General Hospital of Northern Theater Command

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. juni 2026

Primær færdiggørelse (Anslået)

30. august 2026

Studieafslutning (Anslået)

30. september 2026

Datoer for studieregistrering

Først indsendt

26. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • XHNKKY-INPI-1.0

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

The datasets analyzed during the current study are not publicly available due to ethical considerations.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Tarmforberedelse til koloskopi

Kliniske forsøg med Standard bowel preparation guidance

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