Combined Chromoendoscopy and Water Method for Screening Colonoscopy
Randomized Controlled Trial (RCT) to Compare Adenoma Detection Rate of Combined Chromoendoscopy (Indigo Carmine) With Water Infusion in Lieu of Air Insufflation (Water Method) vs. Water Method Alone in Screening Colonoscopy
研究概览
详细说明
Background: Warm water infusion in lieu of air insufflation (water method) improves overall success of screening colonoscopy and our retrospective data indicate a higher adenoma detection rate. Dye spray methods to improve neoplastic polyp detection such as targeted staining or pancolonic chromoendoscopy have been described.
Aim: In a RCT in screening colonoscopy subjects, we will determine if chromoendoscopy using a dilute solution of Indigocarmine (IC) delivered by the water method (study method) will improve adenoma detection rate compared with the water method with plain water alone (control method).
Methods: After informed consent patients undergoing screening colonoscopy will be randomized to be examined by the study or control method. Study method will employ a 0.008% IC solution. Control method will employ plain water. The water method in both study and control groups will be applied as previously described. The colonoscopy will be performed under sedation. Primary outcome measure: adenoma detection rate; secondary outcome: relevant procedure-related variables.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Mather、California、美国、95655
- Sacramento VA Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult (≥50 years old
- Male and female patients
- Scheduled for screening colonoscopy
- Consented and accept randomization to study or control method
Exclusion Criteria:
- Patients who decline to participate
- Unable to give informed consent
- Unable to complete questionnaires due to language or other difficulties
学习计划
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:单组作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Water method and chromoendoscopy
Combined water method with chromoendoscopy using 0.008% IC solution for screening colonoscopy
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Study method will employ a 0.008% IC solution used with the water method for screening colonoscopy
其他名称:
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有源比较器:Water method
Control method will use plain water with the water method for screening colonoscopy
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Control method will use plain water with water method for screening colonoscopy
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Diagnosis of adenoma
大体时间:24 months
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24 months
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合作者和调查者
调查人员
- 首席研究员:Joseph Leung, MD、Sacramento VA Medical Center
出版物和有用的链接
一般刊物
- Leung J, Mann S, Siao-Salera R, Ransibrahmanakul K, Lim B, Canete W, Samson L, Gutierrez R, Leung FW. A randomized, controlled trial to confirm the beneficial effects of the water method on U.S. veterans undergoing colonoscopy with the option of on-demand sedation. Gastrointest Endosc. 2011 Jan;73(1):103-10. doi: 10.1016/j.gie.2010.09.020.
- Leung JW, Mann SK, Siao-Salera R, Ransibrahmanakul K, Lim B, Cabrera H, Canete W, Barredo P, Gutierrez R, Leung FW. A randomized, controlled comparison of warm water infusion in lieu of air insufflation versus air insufflation for aiding colonoscopy insertion in sedated patients undergoing colorectal cancer screening and surveillance. Gastrointest Endosc. 2009 Sep;70(3):505-10. doi: 10.1016/j.gie.2008.12.253. Epub 2009 Jun 24.
- Leung J, Mann S, Siao-Salera R, Ngo C, McCreery R, Canete W, Leung F. Indigocarmine added to the water exchange method enhances adenoma detection - a RCT. J Interv Gastroenterol. 2012 Jul;2(3):106-111. doi: 10.4161/jig.23728. Epub 2012 Jul 1.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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