Efficacy of addition of oral simethicone on the quality of bowel preparation for colonoscopy– a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Boston Bowel Preparation Scale
研究概览
简要总结
Colonoscopy is considered to be the gold standard investigation for assessing colonic lesions; but many factors, such as the quality of bowel preparation, endoscopist, and patient factors, may affect the diagnostic accuracy and therapeutic safety. Inadequate bowel preparation has been reported in 10%-75% of colonoscopic examinations. For bowel preparation, laxatives such as polyethylene glycol (PEG), magnesium citrate plus picosulfate, and oral sulfate are consumed with water. During the bowel cleansing process, many bubbles are generated because a large amount of water mixed with mucus and bile. Endoscopists encounter a new obstacle -bubbles- even in the absence of stool. Polyethylene glycol (PEG), an orally-administered purgative, is recommended as the first-line bowel preparation regimen, mainly due to its effectiveness and safety. Simethicone (CH3)2 SiO, a silicone-based polymer, can disperse bubbles by decreasing surface tension. The hypothesis of this project is that addition of simethicone to low-volume PEG solution improves bowel-cleansing efficacy and compliance with shorter caecal intubation time and higher Adenoma Detection Rate. Hence the primary objective of this study is to compare the quality of colonoscopy bowel preparation of patients taking low volume PEG-Electrolyte solution(PEG-ELSE) with patients taking simethicone along with PEG-ELS. Secondary Objective is to compare the visibility, caecal intubation time, withdrawal time, adenoma detection rate and incidence of adverse events in patients taking low volume PEG-ELS solution with patients taking simethicone along with PEG-ELS solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 74.00 Year(s)(—)
- 性别
- All
入选标准
- •Consecutive adult patients aged between 18 and 74 years who were scheduled for diagnostic colonoscopy.
排除标准
- •Previous history of abdominal surgery Chronic kidney disease with eGFR less than 60ml per min per 1.73m2 Congestive heart failure with New York Heart Association class II to IV Pregnancy or lactation Inflammatory bowel disease Psychiatric illness including diagnosed case of psychosis or schizophrenia or dementia Any patient with suspected lower gastrointestinal bleed.
结局指标
主要结局
Boston Bowel Preparation Scale
时间窗: Baseline, during colonoscopy
次要结局
- Bubble score(Caecal intubation time)
研究者
Sukrati Maheshwari
Kalinga Institute of Medical Sciences, Bhubaneswar
