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临床试验/NCT03157791
NCT03157791已完成4 期

Addition of Oral Simethicone to Bowel Preparation in Colonoscopy

University of Manitoba1 个研究点 分布在 1 个国家目标入组 471 人开始时间: 2017年7月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
471
试验地点
1
主要终点
Bubble Scale Score

研究概览

简要总结

This Clinical Trial is being conducted to study the effect of oral simethicone on the presence of bubbles during colonoscopy. The purpose of this study is to find out what effects (good and bad) the addition of oral simethicone to bowel preparation has on the ability to visualize the colon mucosa (bowel) during colonoscopy.

详细描述

Evaluation of the lower gastrointestinal (GI) tract by colonoscopy is now considered the gold standard and its use is on the rise in all GI units. Clean bowel preparation is a mandatory part of the procedure in order to visualize the bowel mucosa to determine pathology and provide therapeutic intervention safely if needed.

Colon lavage preparations have been effective in improving visibility of the colon and are well tolerated. Split dose bowel preparation regimens have been developed and adapted in order to optimize patient comfort and provide adequate cleanliness .

These bowel preparations address issues regarding the feculent residual material, however bubbles lining the mucosa remain a problem in attempting to visualize the colon mucosa. About 30% of adequately prepared bowels are now affected with mucosa lined with bubbles . The bubbles limit evaluation of the entire bowel, requiring more time to clean the bowel and possibly missing pathology such as small, flat sessile, serrated polyps, small apthous ulcers for crohns and many other pathologies.

Simethicone is a mixture of polydimethylsiloxane and hydrated silica gel and works by reducing surface tension of air bubbles, allowing small bubbles to coalesce to form larger bubbles allowing the air to pass as belching or flatulence. This makes simethicone an ideal antifoaming agent that has been used in all age groups to reduce bloating, abdominal discomfort, and abdominal pain.

In the past, use of simethicone in the irritant fluid has been used to wash away the bubbles, however there has been recent concern with scope manufacturers advising that simethicone not to be used routinely because of simethicone settling in the irrigation channel. This causes a concerning biofilm in the endoscope.

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
Double (Investigator, Outcomes Assessor)

盲法说明

The endoscopist and endoscopy nurse will not know to which treatment arm the patient belongs as only the interviewing nurse will have taken down this information. This information does not travel with the patient to the endoscopy room. The patient is also instructed to not reveal to the endoscopist or endoscopy nurse if he or she has taken simethicone or not.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients receiving colonoscopy who are within 30km of Brandon Manitoba and no other exclusion criteria

排除标准

  • inability to provide informed consent, under 18 years old, inpatient, pregnancy, known hypersensitivity to simethicone, or excessive language barriers.

研究组 & 干预措施

Simethicone with Bowel Prep

Experimental

Group A will receive 2 simethicone tablets (180mg each) so that one tablet is taken at the same time as each bowel preparation dose.

干预措施: Simethicone 180Mg Cap (Drug)

结局指标

主要结局

Bubble Scale Score

时间窗: Will be completed immediately after colonoscopy is completed

The scale grades the amount of bubbles present in the colon from 0 (none) to 3 (severe)

次要结局

  • Ottawa Stool Scale(Will be completed immediately after colonoscopy is completed)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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