Split Dose Golytely With Amitiza Pretreatment Versus Split Dose Golytely Plus Placebo in Outpatient Colonoscopy
2012年10月3日 更新者：Joel Z. Stengel、Brooke Army Medical Center
Single Dose Lubiprostone Along With Split-dose PEG Solution Without Dietary Restrictions for Bowel Cleansing Prior to Colonoscopy, a Randomized, Double-blind, Placebo Controlled Trial
The primary outcomes of this procedure will be: 1.
The cleanliness of the prep as measured by the Ottawa Scale (attachment a).
Secondary outcomes will be: 1. Patient satisfaction with the prep measured by 5 point Likert scale (attachment b); 2. Procedure time; 3. The number and size of polyps detected on examination.
研究概览
研究类型
介入性
注册 (实际的)
191
阶段
- 不适用
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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Fort Sam Houston、Texas、美国、78234
- Brooke Army Medical Center
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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
18年 及以上 (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:
- Adult patients referred to our clinic for Average or Increased Risk screening for Colorectal Cancer
- Ages will be from 18 years of age and older
Exclusion Criteria:
- Chronic kidney disease
- Previous diagnosis of congestive heart failure
- History of bowel obstruction
- History of solid organ transplant
- Pregnancy
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：治疗
- 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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有源比较器：1
split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
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lubiprostone 24mcg gelcap, 1 gelcap taken at noon the day prior to the colonoscopy
其他名称：
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安慰剂比较：2
split-dose PEG solution without dietary restrictions plus placebo pretreatment
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placebo gelcap, taken at noon the day prior to the colonoscopy
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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 |
|---|---|---|
|
The Overall Cleanliness of the Prep as Measured by the Ottawa Scale
大体时间：measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
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Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy.
Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy.
The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy.
This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2).
The total score ranges from 0 to 14.
An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7would indicate progressively worsening bowel preparations.
A completely unprepared colon would score 11-14, depending on the amount of colonic fluid
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measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
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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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Patient Satisfaction With the Prep Measured by 5 Point Likert Scale
大体时间：measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)
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The participants completed a survey prior to the colonoscopy that graded their overall satisfaction with the bowel preparation.
The subjects rated the survey questions on a 5-point Likert scale where 1 = severely distressing, 2=distressing, 3=bothersome, 4=mild, and 5=none.
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measured after completion of the bowel preparation and prior to the colonoscopy, completed during the course of the study (approximately 4 month period)
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Procedure Time
大体时间：measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
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Procedure time refers to the total length of time required to complete the colonoscopy
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measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
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The Number of Polyps Detected on Examination
大体时间：measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
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The number of colon polyps detected during the colonoscopy.
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measured upon completion of the colonoscopy, colonoscopies completed during the course of the study (approximately 4 month period)
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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。
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
- Tan JJ, Tjandra JJ. Which is the optimal bowel preparation for colonoscopy - a meta-analysis. Colorectal Dis. 2006 May;8(4):247-58. doi: 10.1111/j.1463-1318.2006.00970.x.
- Harewood GC, Wiersema MJ, Melton LJ 3rd. A prospective, controlled assessment of factors influencing acceptance of screening colonoscopy. Am J Gastroenterol. 2002 Dec;97(12):3186-94. doi: 10.1111/j.1572-0241.2002.07129.x.
- El Sayed AM, Kanafani ZA, Mourad FH, Soweid AM, Barada KA, Adorian CS, Nasreddine WA, Sharara AI. A randomized single-blind trial of whole versus split-dose polyethylene glycol-electrolyte solution for colonoscopy preparation. Gastrointest Endosc. 2003 Jul;58(1):36-40. doi: 10.1067/mge.2003.318.
- Church JM. Effectiveness of polyethylene glycol antegrade gut lavage bowel preparation for colonoscopy--timing is the key! Dis Colon Rectum. 1998 Oct;41(10):1223-5. doi: 10.1007/BF02258217.
- Lacy BE, Levy LC. Lubiprostone: a chloride channel activator. J Clin Gastroenterol. 2007 Apr;41(4):345-51. doi: 10.1097/01.mcg.0000225665.68920.df.
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
2007年10月1日
初级完成 (实际的)
2008年1月1日
研究完成 (实际的)
2008年1月1日
研究注册日期
首次提交
2008年1月29日
首先提交符合 QC 标准的
2008年1月29日
首次发布 (估计)
2008年2月11日
研究记录更新
最后更新发布 (估计)
2012年11月1日
上次提交的符合 QC 标准的更新
2012年10月3日
最后验证
2012年10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.