Endoscopy Nurse Participation in Adenoma Detection Rate During Colonoscopy
Can Involvement of Endoscopy Nurse Participation Increase Adenoma Detection Rate During Screening Colonoscopy?:A Prospective Multicenter Randomized Trial
Colorectal cancer (CRC) is the second most common cancer and the fourth leading cause of cancer death in Korea. Colonoscopy with polypectomy decreases the incidence and mortality from colorectal cancer. However, significant lesions can be missed during colonoscopy. Recent retrospective studies have shown that fellow involvement as a second observer may increase adenoma detection rate in colonoscopy.
The aim of this prospective, multicenter, randomized study is to evaluate the impact when endoscopy nurse participate in adenoma detection during screening colonoscopy. The primary outcome measure is the adenoma detection rate (ADR).
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
-
Cheonan、大韩民国
- Dankook University Hospital
-
Cheonan、大韩民国
- Soon Chun Hyang University Cheonan Hospital
-
Guri、大韩民国
- Hanyang University Guri Hospital
-
Incheon、大韩民国
- The Catholic University Incheon St. Mary's Hospital
-
Seoul、大韩民国
- Kangbuk Samsung Hospital
-
Seoul、大韩民国
- Kyung Hee University Gangdong Hospital
-
-
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:
- age over 50
- screening colonoscopy
Exclusion Criteria:
- History of colorectal surgery
- History of hereditary colorectal cancers or polyposis syndrome
- Gastrointestinal bleeding
- Inflammatory bowel diseases
- Inability to provide informed consent
- Pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：endoscopist only
|
Single inspection by endoscopist during colonoscopy
Dual inspection by both endoscopist and nurse during colonoscopy
|
|
实验性的：nurse participation
|
Single inspection by endoscopist during colonoscopy
Dual inspection by both endoscopist and nurse during colonoscopy
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
腺瘤检测率
大体时间：1年
|
1年
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
subjects with at least one polyp
大体时间：1 year
|
1 year
|
|
Subjects with at least one adenoma
大体时间：1 year
|
1 year
|
|
total number of polyp
大体时间：1 year
|
1 year
|
|
total number of adenoma
大体时间：1 year
|
1 year
|
|
Subjects with at least one advanced adenoma or cancer
大体时间：1 year
|
1 year
|
|
total number of advanced adenoma or cancer
大体时间：1 year
|
1 year
|
|
polyp and adenoma detection rate according to the endoscopists or nurse experience
大体时间：1 year
|
1 year
|
合作者和调查者
出版物和有用的链接
一般刊物
- Rogart JN, Siddiqui UD, Jamidar PA, Aslanian HR. Fellow involvement may increase adenoma detection rates during colonoscopy. Am J Gastroenterol. 2008 Nov;103(11):2841-6. doi: 10.1111/j.1572-0241.2008.02085.x. Epub 2008 Aug 27.
- Peters SL, Hasan AG, Jacobson NB, Austin GL. Level of fellowship training increases adenoma detection rates. Clin Gastroenterol Hepatol. 2010 May;8(5):439-42. doi: 10.1016/j.cgh.2010.01.013. Epub 2010 Feb 1.
- Lee CK, Park DI, Lee SH, Hwangbo Y, Eun CS, Han DS, Cha JM, Lee BI, Shin JE. Participation by experienced endoscopy nurses increases the detection rate of colon polyps during a screening colonoscopy: a multicenter, prospective, randomized study. Gastrointest Endosc. 2011 Nov;74(5):1094-102. doi: 10.1016/j.gie.2011.06.033. Epub 2011 Sep 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
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.