Individualized Non-pharmacological Intervention for Bowel Preparation

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Other 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.
• Other 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.
• Other Standard bowel preparation guidance
  Patients receive verbal bowel preparation instruction and printed text-based bowel preparation education materials.

Primary outcome measures

• Bowel preparation quality [Time frame: Assessed by the endoscopist during colonoscopy procedure]

Secondary outcome measures (4)

• Incidence of bowel preparation-related adverse events [Time frame: Recorded during the waiting period prior to colonoscopy procedure]
• Polyp/adenoma detection rate [Time frame: Assessed by the endoscopist during colonoscopy procedure]
• Compliance of bowel preparation [Time frame: Assessed during the waiting period prior to colonoscopy procedure]
• Willingness to undergo colonoscopy again (yes/no) [Time frame: Assessed during the waiting period prior to colonoscopy procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• General Hospital of Northern Theater Command — Shenyang

Identifiers

NCT: NCT07684716 · XHNKKY-INPI-1.0

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗