Randomized Controlled Trial of Different Ratios of Electrolyte Beverage and Water Combined With Polyethylene Glycol on Bowel Preparation Quality and Ingestion Rhythm Before Colonoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 405
- 试验地点
- 1
研究概览
简要总结
This randomized controlled trial aims to evaluate the effects of different ratios of electrolyte beverage and water combined with polyethylene glycol (PEG) on bowel preparation quality before colonoscopy. Participants undergoing elective colonoscopy will be randomly assigned to one of three bowel preparation regimens: PEG prepared with water only, PEG prepared with a low ratio of electrolyte beverage and water, or PEG prepared with a medium ratio of electrolyte beverage and water. The primary outcome is adequate bowel preparation assessed by the Boston Bowel Preparation Scale (BBPS). Secondary outcomes include bowel preparation completion rate, tolerability, adverse events, repeat colonoscopy rate, adenoma detection rate, and ingestion rhythm characteristics during bowel preparation. This study also aims to explore whether electrolyte beverage-assisted bowel preparation may improve bowel cleansing quality by influencing participants' ingestion rhythm and adherence during PEG intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-75 years scheduled to undergo elective colonoscopy
- •Meet the standard clinical indications for colonoscopy;
- •Able to understand and comply with the bowel preparation procedure and complete oral polyethylene glycol (PEG) intake as required;
- •Able to comply with study-related data collection and follow-up;
- •Provide written informed consent voluntarily.
排除标准
- •Previously diagnosed colorectal cancer, intestinal obstruction, or suspected intestinal obstruction;
- •Active gastrointestinal bleeding or a definite history of gastrointestinal bleeding within the past 4 weeks (including melena, hematochezia, or hematemesis);
- •Severe renal insufficiency, decompensated heart failure, significant electrolyte imbalance, or other conditions unsuitable for PEG bowel preparation;
- •Known allergy to polyethylene glycol or components of the electrolyte beverage used in the study;
- •Pregnant or breastfeeding women;
- •Any other condition considered by the investigators to make the participant unsuitable for the study.