Risk Factors for Inadequate Bowel Preparation Before Colonoscopy

March 14, 2025 updated by: Zhaoshen Li, Changhai Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The target population includes outpatients and inpatients scheduled for colonoscopy or polypectomy in the gastroenterology departments of participating centers between February 2025 and February 2026.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adequate bowel preparation rate
Time Frame: The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy
The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy

Secondary Outcome Measures

Outcome Measure
Time Frame
adenoma detection rate
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHEC2025-083

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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