Risk Factors for Inadequate Bowel Preparation Before Colonoscopy

Last updated: March 14, 2025
Sponsor: Changhai Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer Screening

Treatment

Investigation of Factors Influencing Bowel Preparation Quality

Clinical Study ID

NCT06878378
CHEC2025-083
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged >18 years, regardless of gender, scheduled for colonoscopy

  • Written informed consent has been obtained

Exclusion

Exclusion Criteria:

  • History of acute myocardial infarction (within 6 months), severecardiac/hepatic/renal insufficiency, or psychiatric disorders

  • Current use of anticoagulants (e.g., aspirin, warfarin) or presence of coagulationdisorders

  • 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-Jegherssyndrome;

  • History of intestinal obstruction, perforation, stricture, or other conditionsprecluding completion of colonoscopy;

  • Non-compliance with bowel preparation protocols (e.g., ingestion of <80% ofprescribed polyethylene glycol (PEG) electrolyte solution);

  • Severe hearing impairment, cognitive dysfunction, or inability to cooperate with thestudy;

  • Prior enrollment in this study with a repeat colonoscopy appointment;

  • Current participation in other clinical trials or participation in any trial withinthe preceding 60 days;

  • Refusal to provide written informed consent.

Study Design

Total Participants: 10000
Treatment Group(s): 1
Primary Treatment: Investigation of Factors Influencing Bowel Preparation Quality
Phase:
Study Start date:
February 21, 2025
Estimated Completion Date:
February 01, 2026

Study 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.

Connect with a study center

  • Changhai Hospital

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

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