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临床试验/NCT03166605
NCT03166605Unknown不适用

Ingestion of Simethicone After Capsule Ingestion and Its Impact on Quality of Video Capsule Endoscopy- a Pilot Study

Albany Medical College1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年5月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
36
试验地点
1
主要终点
Small bowel visualization quality (SBVQ)

研究概览

简要总结

Wireless video capsule endoscopy (VCE) is a non-invasive technology that looks into small intestine and gives images of its lumen as the wireless capsule passes through it. It is used widely to access this anatomically difficult part of the body that cannot be seen via either colonoscopy or endoscopy. Currently various studies have been done that give multiple comparisons between various bowel preparation in terms of quality of the small bowel visualization. No studies have been done where simethicone (Gas-X) is ingested after capsule swallowing. We intend to give patients simethicone 1 hour after capsule ingestion for two consecutive hours and compare results of capsule endoscopy outcomes like small bowel transit time (SBTT), diagnostic yield (DY), small bowel visualization quality (SBVQ) and completion rate (CR).

详细描述

Currently various studies have been done that give multiple comparisons between various bowel preparation in terms of small bowel transit time (SBTT), diagnostic yield (DY), small bowel visualization quality (SBVQ), completion rate (CR). Studies suggest that using Polyethylene glycol (PEG) prep is significantly better compared to clear liquid and overnight fast in terms if SBVQ and DY (Rokkas et al 2009). Other studies have shown using simethicone 30 minutes before capsule ingestion increases visibility compared to clear liquid and PEG preparation but no significant difference in gastrointestinal transit time or examination completion rate (Wei et al 2008). No studies have been done where simethicone is ingested after capsule swallowing.

Simethicone helps absorb the air bubble in the lumen which can improve the image quality. It decreases the surface tension of gas bubbles thereby dissolving them and preventing gas pockets from forming in GI system. It's often used over the counter for gas relief. Gastric emptying time is usually less than 5 hours, small bowel transit time is usually less than 6 hours, and colonic transit time is usually less than 59 hours (Rao et al 2009). Giving simethicone till 2 hours after swallowing capsule can help clear gas bubble before the capsule migrates into the small bowel.

Albert et al 2004 gave patients 80mg simethicone before swallowing the wireless capsule for their study. Wei et al 2008 gave 300mg of simethicone 20 minutes before swallowing the capsule. Chen et al 2011 gave 20ml (40mg/ml) simethicone 30 minutes before capsule ingestion which amounts to 800 mg total. Current FDA recommendation for adults is 500mg maximum daily dose. The liquid form comes in concentration of 20mg/0.3ml which constitutes to 7.5 ml for 500mg dose.

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 (Care Provider, Outcomes Assessor)

盲法说明

Randomized control

入排标准

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

入选标准

  • patients aged 18 and older
  • patients undergoing capsule endoscopy for standard of care
  • patients able to give consent for themselves

排除标准

  • prisoners

研究组 & 干预措施

Sham

Sham Comparator
  • Receive 3 ml simethicone 20 minutes prior to capsule swallowing
  • Do not drink anything for an additional 2 hours after swallowing pill cam. After which patient may drink clear liquids
  • Do not eat solid food until 4 hours after swallowing. After which patient may eat light that includes soup, toast.
  • Return to clinic (RTC) 8 hours after to remove equipment
  • Avoid carbonated beverages and gas forming foods for the completion of the 8-hours study period.

干预措施: Simethicone (Drug)

Experiment

Experimental
  • Receive 3 ml simethicone 20 minutes prior to capsule swallowing.
  • Receive 3 ml simethicone 1 hours after capsule swallowing
  • Receive 1.5 ml simethicone 2 hours after capsule swallowing
  • Do not drink anything for an additional 1 hour after taking last simethicone dose. After which patient may drink clear liquids
  • Do not eat solid food until 4 hours after swallowing. After which patient may eat light that includes soup, toast.
  • Return to clinic (RTC) 8 hours after to remove equipment
  • Avoid carbonated beverages and gas forming foods for the completion of the 8-hours study period.

干预措施: Simethicone (Drug)

结局指标

主要结局

Small bowel visualization quality (SBVQ)

时间窗: 8 hours

次要结局

  • Diagnostic yield (DY)(8 hours)
  • completion rate (CR)(8 hours)
  • Small bowel transit time (SBTT),(8 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gurjiwan Virk

MD, Resident Physician

Albany Medical College

研究点 (1)

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