A Predictive Model for Inadequate Bowel Preparation: Development and Validation With a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 429
- 试验地点
- 1
- 主要终点
- Quality of Bowel Preparation
研究概览
简要总结
We aimed to develop a predictive model of inadequate bowel preparation and to further validate it by a randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, 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 aged 18-75 years undergoing colonoscopy
排除标准
- •known or suspected bowel obstruction, stricture or perforation
- •compromised swallowing reflex or mental status
- •severe chronic renal failure(creatinine clearance < 30 ml/min)
- •severe congestive heart failure (New York Heart Association class III or IV)
- •uncontrolled hypertension (systolic blood pressure > 170 mm Hg, diastolic blood pressure > 100 mm Hg)
- •dehydration
- •disturbance of electrolytes
- •pregnancy or lactation
- •hemodynamically unstable
- •unable to give informed consent
研究组 & 干预措施
Tailored Group
In the tailored group, high-risk patients are instructed to drink the first 2 L of Polyethylene Glycol (PEG) at 19:00-21:00 hours on the day before colonoscopy at a rate of 250 ml every 15 min. On the day of the procedure, they take another 2 L PEG 4-6 h before colonoscopy. The low-risk patients were given a standard dose of 2 L PEG 4-6 h before colonoscopy.
干预措施: Polyethylene Glycol (Drug)
Control Group
In the control group, all the patients drink single dose of 2 l Polyethylene Glycol (PEG) 4-6 h before colonoscopy at a rate of 250 ml every 15 min.
干预措施: Polyethylene Glycol (Drug)
结局指标
主要结局
Quality of Bowel Preparation
时间窗: 10 months
The quality of bowel preparation is evaluated using BBPS.
次要结局
- Adverse Events(10 months)
- Adenoma Detection Rate(10 months)
- Polyp Detection Rate(10 months)
研究者
Xiuli Zuo
director of Qilu Hospital gastroenterology department
Shandong University