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Recruiting NCT06878378

Risk Factors for Inadequate Bowel Preparation Before Colonoscopy

Observational Colonoscopy Colonoscopy: Bowel Preparation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Investigation of Factors Influencing Bowel Preparation Quality.
Who it may be relevant to
Registry conditions: Colonoscopy, Colonoscopy: Bowel Preparation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed 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.

Interventions

  • Other Investigation of Factors Influencing Bowel Preparation Quality
    Observed parameters include BMI, history of abdominal surgery, history of diabetes, history of diarrhea and constipation, stool characteristics, and specific bowel preparation protocols.

Primary outcome measures

  • adequate bowel preparation rate [Time frame: The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy]
Secondary outcome measures (1)
  • adenoma detection rate [Time frame: 1 year]

Eligibility criteria

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.

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

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Changhai Hospital — Shanghai

Identifiers

NCT: NCT06878378 · CHEC2025-083

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗