Effect of Simethicone on Screening Colonoscopy
2019年6月3日 更新者：Antonio Mendoza-Ladd、Texas Tech University Health Sciences Center, El Paso
The Effect Of Adding High Dose Simethicone To A Standard Polyethylene Glycol Preparation On Adenoma Detection Rate During Screening Colonoscopy: A Randomized Controlled Pilot Trial
This study is evaluating the effect of adding a high dose of simethicone to the standard polyethylene glycol preparation for screening colonoscopy in the quality of the preparation , adenoma detection rate and withdrawal times.
研究概览
详细说明
A proper bowel preparation is key to a thorough and safe colonoscopy.
Several factors affect the mucosal visualization during colonoscopy, and consequently the quality of such evaluation.
Undoubtedly, this can have unfavorable implications like missed lesions.
One of the most commonly encountered scenarios is the presence of multiple bubbles that interfere with mucosal visualization.
When this occurs, simethicone (an antifoam agent used to reduce bloating when ingested orally) is injected through the colonoscope to eliminate the bubbles and get a clear view of the mucosa.
A few studies have used oral simethicone in conjunction with oral preparation agents (PEG, magnesium citrate, sodium phosphate) in an attempt to improve the quality of the preparation.
Unfortunately these studies have not used the exact same preparation agent with and without simethicone, making it difficult to draw conclusions on its efficacy.
However, it is important to understand that simethicone is not intended to decrease the amount of stool in the colon, and it's purpose is to decrease the amount of bubbles interfering with the visualization of the mucosa provided that there is no stool present .
Furthermore, it is unclear if adding simethicone to a standard bowel preparation makes a significant difference in key aspects of screening colonoscopy such as adenoma detection rate or withdrawal times.
This prospective randomized controlled, observer blinded study at Texas Tech University Health Sciences Center in El Paso, aims at studying the effect of simethicone on the overall colon preparation as well as on adenoma detection rate and withdrawal times.
研究类型
介入性
注册 (实际的)
268
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Texas
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El Paso、Texas、美国、79905
- Texas Tech University Health Sciences Center El Paso
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
30年 至 80年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients between the ages of 30-80 scheduled for screening colonoscopy.
- Male and female patients
- Ambulatory patients
- Signed informed consent form
Exclusion Criteria:
- Previous colonic surgery
- Patient with mental/physical condition that impairs oral ingestion of preparation
- Allergy or hypersensitivity to simethicone
- Patients with limited mobility (bedridden patients)
- Patients with gastrointestinal obstruction
- Patients with gastroparesis
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Simethicone solution + Polyethylenglycol
This arm of the study will include the patients assigned to take simethicone solution with their colon preparations ( 4L Polyethyleneglycol)
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Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol
其他名称：
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有源比较器：Polyethylenglycol
This arm of the study will include the patients assigned to take a regular bowel preparation (4L Polyethylenglycol)
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Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Adenoma Detection Rate
大体时间：25 minutes
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The number of adenomatous polyps removed at colonoscopy
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25 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Withdrawal Times
大体时间：6-10 minutes
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Amount spent withdrawing the scope during the colonoscopy
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6-10 minutes
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Colon Preparation
大体时间：25 minutes
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Boston Bowel Preparation Scale (BBPS): scale that rates the quality of the colon preparation based on the amount of stool present. 0:solid stool that cannot be cleared; 1:areas not well seen due to residual stool and/or opaque liquid; 2:small fragments of stool and/or opaque liquid, but mucosa seen well; 3:no residual stool or opaque liquid seen. Score determined by adding the score of each individual segment of the colon (right side, transverse and left side). Scores range from 0 to 3 in each segment, therefore, a total composite score ranges from 0 (poor) to 9 (excellent). Bubble Score (BS): scale that rates the amount of bubbles present in the colon. 0:no or minimal bubbles; 1:bubbles covering up to half the luminal diameter; 2:bubbles covering the circumference of the lumen; 3:bubbles filling the entire lumen. Score determined the same way as BBPS score but in this case a total score of 0 is excellent and 9 is poor. |
25 minutes
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Intraprocedural Use of Simethicone
大体时间：6-10 minutes
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The number of colonoscopies during which the endoscopist requested simethicone to be flushed through the endoscope.
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6-10 minutes
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Antonio H Mendoza-Ladd, MD、Texas Tech University Health Sciences Center, El Paso
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Yoo IK, Jeen YT, Kang SH, Lee JH, Kim SH, Lee JM, Choi HS, Kim ES, Keum B, Chun HJ, Lee HS, Kim CD. Improving of bowel cleansing effect for polyethylene glycol with ascorbic acid using simethicone: A randomized controlled trial. Medicine (Baltimore). 2016 Jul;95(28):e4163. doi: 10.1097/MD.0000000000004163.
- Park JJ, Lee SK, Jang JY, Kim HJ, Kim NH. The effectiveness of simethicone in improving visibility during colonoscopy. Hepatogastroenterology. 2009 Sep-Oct;56(94-95):1321-5.
- Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.
- Rex DK, Petrini JL, Baron TH, Chak A, Cohen J, Deal SE, Hoffman B, Jacobson BC, Mergener K, Petersen BT, Safdi MA, Faigel DO, Pike IM. Quality indicators for colonoscopy. Gastrointest Endosc. 2006 Apr;63(4 Suppl):S16-28. doi: 10.1016/j.gie.2006.02.021. No abstract available.
- Moraveji S, Casner N, Bashashati M, Garcia C, Dwivedi A, Zuckerman MJ, Carrion A, Ladd AM. The role of oral simethicone on the adenoma detection rate and other quality indicators of screening colonoscopy: a randomized, controlled, observer-blinded clinical trial. Gastrointest Endosc. 2019 Jul;90(1):141-149. doi: 10.1016/j.gie.2019.03.018. Epub 2019 Mar 26.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月15日
初级完成 (实际的)
2019年4月10日
研究完成 (实际的)
2019年4月10日
研究注册日期
首次提交
2017年4月10日
首先提交符合 QC 标准的
2017年4月13日
首次发布 (实际的)
2017年4月18日
研究记录更新
最后更新发布 (实际的)
2019年6月5日
上次提交的符合 QC 标准的更新
2019年6月3日
最后验证
2019年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Simethicone Solution的临床试验
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