The Efficacy and Tolerability of Mizone Versus Water in Bowel Preparations: a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Quality of Bowel Preparation
研究概览
简要总结
In order to analyze the effectiveness and patient tolerance of the two bowel preparation regimens, we will compare Polyethylene Glycol Electrolytes Powder (PEG-4000) and Mizone with PEG-ELS. The aim was to demonstrate that polyethylene glycol electrolyte powder (PEG-4000) and Mizone is not inferior in overall quality of intestinal preparation to PEG-ELS in subjects undergoing colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •Patients age between 18-75 years old requiring colonoscopy and willing to participate in this study.
排除标准
- •Patients with constipation;
- •Patients with congestive heart failure;
- •Patients with a history of kidney disease;
- •Patients with a history of poor intestinal preparation;
- •Pregnant / lactating women;
- •Patients without informed consent;
- •Allergic or intolerant to any research drug;
- •Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon;
- •Patients with a history of inflammatory bowel disease;
- •Significant electrolyte anomalies, including phosphorus, sodium, potassium, calcium, chloride and magnesium;
- •History of colorectal resection；
- •Patients with diabetes.
研究组 & 干预措施
PEG-Mizone prep
The evening before the colonoscopy: The patients who are randomized to the " PEG-Mizone prep " arm will drink single dose of 60g Polyethylene Glycol (PEG-4000) with 0.6L Mizone+0.4L water at a rate of 250 ml every 15 min.
On the day of the colonoscopy: The patients who are randomized to the " PEG-Mizone prep " arm will drink single dose of 120g Polyethylene Glycol (PEG-4000) with 1.2L Mizone+0.8L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min.
干预措施: PEG-Mizone (Drug)
PEG-ELS prep
The evening before the colonoscopy: In the PEG-ELS prep group, all the patients drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at a rate of 250 ml every 15 min.
On the day of the colonoscopy: all the patients drink single dose of 120g Polyethylene Glycol (PEG-4000) with 2L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min.
干预措施: PEG-ELS (Drug)
结局指标
主要结局
Quality of Bowel Preparation
时间窗: 1 Day of colonoscopy
The OBPS，a scoring system with scores between 0 and 14, where 0 is the best score，divides the colon into 3 segments (right, transverse and rectosigmoid colon); each is scored from 0-4 (0=excellent, If it is necessary to suction liquid stool to adequately see the colonic wall, a score of 2 (fair) is given; if it is necessary to wash and to suction, a score of 3 (poor) is given. The remaining scores fall into place around these anchors. ). A score 0-2 is added to indicate the total amount of luminal fluid.(0=The total amount of fluid in the colon is very small,1=a moderate volume of fluid overall in the colon,2=a large volume of fluid overall in the colon)
次要结局
- Adverse event rate(3 days)
- patient tolerability of bowel preparation(1 Day of colonoscopy)