Risk Factors for Inadequate Bowel Preparation Before Colonoscopy
NCT ID: NCT06878378
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10000 participants
OBSERVATIONAL
2025-02-21
2026-02-01
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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outpatients and inpatients scheduled for colonoscopy or polypectomy
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Written informed consent has been obtained
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Zhaoshen Li
professor
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHEC2025-083
Identifier Type: -
Identifier Source: org_study_id
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