Individualized Non-pharmacological Intervention for Bowel Preparation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral Hospital of Shenyang Military Region

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age ≥ 18 years;

outpatient scheduled for colonoscopy using oral laxatives for bowel preparation;

able to understand the study and provide written informed consent.

Disqualifiers

undergoing emergency colonoscopy;

suspected intestinal obstruction, stricture, or perforation;

severe cardiac, cerebral, hepatic, or renal disease;

severe psychiatric disorder;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Individualized bowel preparation regimen

    Other intervention

    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.

  • Information-framing guidance

    Other intervention

    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.

  • Standard bowel preparation guidance

    Other intervention

    Patients receive verbal bowel preparation instruction and printed text-based bowel preparation education materials.

Treatment groups

339 Participants
are divided into 3 treatment groups
Group A: Standard bowel preparation groupActive comparator 1 intervention
Group B: Individualized bowel preparation groupExperimental treatment 1 intervention
Group C: Information-framing guided individualized bowel preparation groupExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Bowel preparation quality

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.

Time frame
Assessed by the endoscopist during colonoscopy procedure

Secondary outcomes

1

Incidence of bowel preparation-related adverse events

Incidence of nausea, vomiting, abdominal distension, abdominal pain

Time frame
Recorded during the waiting period prior to colonoscopy procedure
2

Polyp/adenoma detection rate

Time frame
Assessed by the endoscopist during colonoscopy procedure
3

Compliance of bowel preparation

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.

Time frame
Assessed during the waiting period prior to colonoscopy procedure
4

Willingness to undergo colonoscopy again (yes/no)

Patients are asked whether they are willing to undergo a repeat colonoscopy.

Time frame
Assessed during the waiting period prior to colonoscopy procedure

Other outcomes

Sponsors and contacts

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