Risk Factors for Inadequate Bowel Preparation Before Colonoscopy

NCT ID: NCT06878378

Last Updated: 2025-03-18

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-21

Study Completion Date

2026-02-01

Brief Summary

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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

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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.

Conditions

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Colonoscopy Colonoscopy: Bowel Preparation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhao-shen Li

Role: CONTACT

0086-13386273620

Zi-xuan He

Role: CONTACT

0086-15901597359

Facility Contacts

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Zhao-shen Li

Role: primary

0086-13386273620

Zi-xuan He

Role: backup

0086-15901597359

Other Identifiers

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CHEC2025-083

Identifier Type: -

Identifier Source: org_study_id

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