Efficacy of Prucalopride Plus Polyethylene Glycol in Bowel Preparation for Colonoscopy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Difference of scores rating by Boston Bowel Preparation Scale between 2 groups.
研究概览
简要总结
Prucalopride based bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.
详细描述
Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost.Unfortunately, despite advances in bowel preparation methods, up to one-third of all colonoscopies are reported to have an inadequate bowel preparation.
Prucalopride can accelerate colonic transit and has been demonstrated to be efficient in constipation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older,
- •scheduled to undergo elective outpatient colonoscopy,
- •and were able to provide informed consent.
排除标准
- •history of colorectal surgery
- •severe colonic stricture or obstructing tumour
- •dysphagia
- •compromised swallowing reflex or mental status
- •significant gastroparesis or gastric outlet obstruction
- •known or suspected bowel obstruction or perforation
- •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
- •haemodynamically unstable
- •unable to give informed consent.
研究组 & 干预措施
Prucalopride group
2 mg Prucalopride plus 2 L Polyethylene Glycol regimen
干预措施: 2 mg Prucalopride plus 2 L Polyethylene Glycol regimen (Drug)
Placebo group
2 mg Placebo plus 2 L Polyethylene Glycol regimen
干预措施: 2 mg Placebo plus 2 L Polyethylene Glycol regimen (Drug)
结局指标
主要结局
Difference of scores rating by Boston Bowel Preparation Scale between 2 groups.
时间窗: 9 months
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between 2 groups.
次要结局
- Polyp detection rate between 2 groups.(9 months)
- rate of adverse events between 2 groups.(9 months)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University