Comparison of Electrolyte Beverages and Water as Solvents for Bowel Preparation: A Single-Blind, Prospective, Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,766
- 试验地点
- 1
- 主要终点
- The Boston Bowel Preparation Scale
研究概览
简要总结
Using Electrolyte Beverages as replacement for water to dissolve PEG(2L plan) in bowel preparation process.
The aim of this study is to test whether Electrolyte Beverages as solvents can improve the cleanness of bowel preparation and the satisfaction of patients.
详细描述
The application of electronic colonoscopy has shown a significant upward trend in the diagnosis, screening, and health check-ups for colorectal diseases.
To clean the colon, patients must consume several liters of bowel preparation solution in a short period before the procedure.
However, a significant number of patients experience nausea or even vomiting, preventing them from completing the recommended dose, resulting in suboptimal bowel preparation and affecting the colonoscopy process.
Therefore, the investigators have designed a protocol that uses sugar-free electrolyte beverages instead of regular drinking water as a solvent for the laxative solution. By improving the taste of the oral solution and increasing the electrolyte content, the investigators aim to enhance patient compliance with colonoscopy preparation and ultimately assess the effectiveness of bowel cleansing.
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
- Double (Care Provider, Investigator)
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
- •Healthy individuals or those with mild or well-controlled chronic diseases.
- •Patients scheduled for outpatient colonoscopy.
- •Patients prescribed sodium phosphate or polyethylene glycol for bowel preparation.
- •Willing to participate and sign the informed consent form.
- •Age ≥18 years
- •ECOG performance status <2
排除标准
- •Patients who refuse to participate in the study.
- •Patients requiring enema preparation.
- •Uncontrolled hypertension.
- •Patients with diabetes.
- •Pregnant patients.
- •Suspected bowel obstruction.
- •Risk of aspiration.
- •Patients with severe ulcerative colitis, gastric retention, bowel perforation, toxic colitis, or megacolon.
- •Patients with severe systemic diseases (including NYHA class 3-4 heart failure, Child-Pugh class C liver failure).
- •Patients with a known allergy to polyethylene glycol.
- •Patients with a history of major gastrointestinal surgery or any other conditions that may interfere with study outcomes or adherence.
结局指标
主要结局
The Boston Bowel Preparation Scale
时间窗: From enrollment to the time point when patients finished colonscopy (within a week).
The BBPS is a standardized 9-point assessment scale for the colon. The structure of the colon is divided into its three segments: right colon, transverse colon, and left colon. Each segment is classified from 0 to 3 depending on the degree of soiling. The sum total of the three segments represents the degree of soiling, so that a total ≤ 5 points shows poor bowel preparation, while 6-7 shows good bowel preparation, and ≥ 8 very good bowel preparation.
次要结局
- The Palatability(From enrollment to the time point when patients finished colonscopy(within a week).)
- Lesion Detection Rate(From enrollment to the time point when patients finished colonscopy (within a week).)
研究者
Weidong Tong
Director
Third Military Medical University