Identification of Risk Factors for Inadequate Bowel Preparation Before Colonoscopy and Construction of a Predictive Model: a Nationwide Multicenter Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- adequate bowel preparation rate
研究概览
简要总结
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.
详细描述
The project is divided into three key phases:
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged >18 years, regardless of gender, scheduled for colonoscopy
- •Written informed consent has been obtained
排除标准
- •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.
结局指标
主要结局
adequate bowel preparation rate
时间窗: The adequate bowel preparation rate can be assessed immediately upon completion of colonoscopy
次要结局
- adenoma detection rate(1 year)