Risk Factors for Inadequate Bowel Preparation Before Colonoscopy

Naval Military Medical University

Status: Enrolling

Conditions: Colonoscopy: Bowel Preparation; Colonoscopy

Treatments: Other: Investigation of Factors Influencing Bowel Preparation Quality

Study type: Observational

Funder types: Other

Identifiers

NCT06878378

CHEC2025-083

Details and patient eligibility

About

The primary objectives of this study are twofold:

Firstly, to investigate the current status of bowel preparation protocols and their quality across hospitals at various levels in China, particularly following the release of the updated 2023 bowel preparation guidelines. This aims to standardize and optimize bowel preparation protocols nationwide.

Secondly, to identify and analyze risk factors contributing to suboptimal bowel preparation quality in patients undergoing colonoscopy. The study will examine the correlation between these factors and bowel preparation scores, establish a risk prediction model for preparation failure, and provide a theoretical foundation for developing personalized bowel preparation regimens tailored to individual patient characteristics.

Full description

The project is divided into three key phases:

1. Initiation Phase:

   Develop a Bowel Preparation Assessment Questionnaire (BPAQ) to standardize data collection.

   Establish collaborative centers (multicenter hospitals) nationwide for coordinated implementation.

2. Implementation Phase:

   Conduct on-site audits to evaluate bowel preparation practices across participating centers.

   Deliver protocol-specific training to healthcare providers, emphasizing compliance with the 2023 guidelines.

   Systematically collect bowel preparation data, including patient demographics, protocol adherence metrics, and clinical outcomes.

3. Conclusion Phase:

Prioritize data quality assurance through dual-entry validation and logic checks to ensure authenticity, comprehensiveness, and objectivity.

Generate consolidated reports to identify systemic gaps and propose evidence-based optimization strategies.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged >18 years, regardless of gender, scheduled for colonoscopy
• Written informed consent has been obtained

Exclusion criteria

• History of acute myocardial infarction (within 6 months), severe cardiac/hepatic/renal insufficiency, or psychiatric disorders
• Current use of anticoagulants (e.g., aspirin, warfarin) or presence of coagulation disorders
• Pregnancy or lactation;
• History of inflammatory bowel disease or acute intestinal infection within the past 2 weeks;
• History of colorectal cancer, familial adenomatous polyposis (FAP), or Peutz-Jeghers syndrome;
• History of intestinal obstruction, perforation, stricture, or other conditions precluding completion of colonoscopy;
• Non-compliance with bowel preparation protocols (e.g., ingestion of <80% of prescribed polyethylene glycol (PEG) electrolyte solution);
• Severe hearing impairment, cognitive dysfunction, or inability to cooperate with the study;
• Prior enrollment in this study with a repeat colonoscopy appointment;
• Current participation in other clinical trials or participation in any trial within the preceding 60 days;
• Refusal to provide written informed consent.

Trial design

10,000 participants in 1 patient group

outpatients and inpatients scheduled for colonoscopy or polypectomy

Description:

The target population includes outpatients and inpatients scheduled for colonoscopy or polypectomy in the gastroenterology departments of participating centers between February 2025 and December 2026. Data from these individuals will be collected to assess factors influencing bowel preparation quality.

Treatment:

Other: Investigation of Factors Influencing Bowel Preparation Quality