Individualized Non-pharmacological Intervention for Bowel Preparation

NCT07684716 | Recruiting

• 1 other identifier: XHNKKY-INPI-1.0
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bowel Preparation for Colonoscopy

Keywords

colonoscopy; bowel praparation; individualized non-pharmacological intervention

Outcome Measures

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.

  Assessed by the endoscopist during colonoscopy procedure

Secondary Outcomes (4)

• Incidence of bowel preparation-related adverse events

  Recorded during the waiting period prior to colonoscopy procedure

• Polyp/adenoma detection rate

  Assessed by the endoscopist during colonoscopy procedure

• Compliance of bowel preparation

  Assessed during the waiting period prior to colonoscopy procedure

• Willingness to undergo colonoscopy again (yes/no)

  Assessed during the waiting period prior to colonoscopy procedure

Study Arms (3)

Standard bowel preparation group

ACTIVE COMPARATOR

Patients receive verbal instructions and printed text-based bowel preparation education materials, along with a standard bowel preparation regimen.

Other: Standard bowel preparation guidance

Individualized bowel preparation group

EXPERIMENTAL

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.

Other: Individualized bowel preparation regimen

Information-framing guided individualized bowel preparation group

EXPERIMENTAL

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.

Other: Individualized bowel preparation regimen; Other: Information-framing guidance

Interventions

Individualized bowel preparation regimen OTHER

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.

Individualized bowel preparation group; Information-framing guided individualized bowel preparation group

Information-framing guidance OTHER

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.

Information-framing guided individualized bowel preparation group

Standard bowel preparation guidance OTHER

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

Standard bowel preparation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years;
• outpatient scheduled for colonoscopy using oral laxatives for bowel preparation;
• able to understand the study and provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

RECRUITING

Study Officials

• Xingshun Qi

  The General Hospital of Northern Theater Command

  STUDY CHAIR

Central Study Contacts

Xingshun Qi

CONTACT

+8618909881019; xingshunqi@126.com

weiyi wang

CONTACT

13019441021; 373302698@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastroenterology

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 6, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)