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NCT Number: NCT06878378

Risk Factors for Inadequate Bowel Preparation Before Colonoscopy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The project is divided into three key phases:

  • Initiation Phase:

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

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

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Investigation of Factors Influencing Bowel Preparation Quality

Other

Observed parameters include BMI, history of abdominal surgery, history of diabetes, history of diarrhea and constipation, stool characteristics, and specific bowel preparation protocols.

Primary outcomes

  1. adequate bowel preparation rate

    Time frame: The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy

Secondary outcomes

  1. adenoma detection rate

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Identification of Risk Factors for Inadequate Bowel Preparation Before Colonoscopy and Construction of a Predictive Model: a Nationwide Multicenter Prospective Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 17, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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