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Risk Factors for Inadequate Bowel Preparation Before Colonoscopy

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06878378
Enrollment
10000
Registered
2025-03-17
Start date
2025-02-21
Completion date
2026-02-01
Last updated
2025-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Colonoscopy: Bowel Preparation

Keywords

bowel preparation, colonoscopy

Brief summary

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

OTHERInvestigation 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.

Sponsors

Changhai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
adequate bowel preparation rateThe adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy

Secondary

MeasureTime frame
adenoma detection rate1 year

Countries

China

Contacts

Primary ContactZhao-shen Li
zhaoshenli@hotmail.com0086-13386273620
Backup ContactZi-xuan He
zixuan931004@163.com0086-15901597359

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026