跳至主要内容
临床试验/CTRI/2024/06/068842
CTRI/2024/06/068842尚未招募3 期

Efficacy of addition of oral simethicone on the quality of bowel preparation for colonoscopy– a Randomized Controlled Trial

Sukrati Maheshwari1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2024年7月30日最近更新:

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

发起方
Sukrati Maheshwari
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sukrati Maheshwari

Kalinga Institute of Medical Sciences, Bhubaneswar

研究点 (1)

Loading locations...

相似试验