Investigating bowel preparation quality before colonoscopy
Identification of Risk Factors for Inadequate Bowel Preparation Before Colonoscopy and Construction of a Predictive Model: a Nationwide Multicenter Prospective Study
Changhai Hospital · NCT06878378
This study is testing how well different bowel prep methods work for people getting a colonoscopy to see if new guidelines can help improve the process.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Changhai Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06878378 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the current bowel preparation protocols and their effectiveness across various hospitals in China, particularly in light of the updated 2023 guidelines. It will identify risk factors that lead to inadequate bowel preparation in patients scheduled for colonoscopy. The study involves developing a standardized questionnaire for data collection, conducting audits of preparation practices, and training healthcare providers on compliance with the new guidelines. Ultimately, it seeks to create a risk prediction model and propose personalized bowel preparation strategies based on individual patient characteristics.
Who should consider this trial
Good fit: Ideal candidates include patients over 18 years old who are scheduled for a colonoscopy and can provide informed consent.
Not a fit: Patients with severe health conditions, recent surgeries, or those unable to comply with bowel preparation protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved bowel preparation quality, enhancing the effectiveness of colonoscopy procedures for patients.
How similar studies have performed: While there have been studies on bowel preparation, this specific approach focusing on risk factors and standardization in China is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- Changhai Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Zhao-shen Li
- Email: zhaoshenli@hotmail.com
- Phone: 0086-13386273620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colonoscopy, Colonoscopy: Bowel Preparation, bowel preparation, colonoscopy