Telemark Polyp Study, a Trial on Colonoscopy Screening (TPS)
Telemark Polyp Study, a Randomized Trial on Colonoscopy Screening
Colonoscopy screening to reduce mortality and incidence of colorectal cancer (CRC) has been implemented in many western countries. The estimated effect is based on case-control and observational studies. There are no randomized trials quantifying the effect of colonoscopy screening on CRC incidence and mortality.
The present study investigates the effect of a population-based once-only colonoscopy screening with polypectomy on the incidence of CRC in an average risk population.
In 1983, 900 individuals 55 to 64 years of age were randomly drawn from the population registry of Telemark county, Norway. 400 of these were invited to a flexible sigmoidoscopy screening examination, and 400 individuals were not offered any screening. In 1996, the remainder, both cohorts from 1983 were invited to a colonoscopy screening examination. A new age and sex matched control group, not being offered screening, was randomly drawn from the same registry. Both groups are to be followed with regard to CRC incidence, CRC mortality and all-cause mortality through national Norwegian registries.
研究概览
详细说明
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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Oslo、挪威
- Cancer Registry of Norway
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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:
- Age 55 to 64 years old
- Both male and female
Exclusion criteria:
- Colorectal cancer diagnosed before study entry
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 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 |
|---|---|
|
有源比较器:Flexible Sigmoidoscopy Screening arm
Intervention by flexible sigmoidoscopy screening
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sigmoidoscopy screening
其他名称:
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无干预:Control arm
No intervention (no screening)
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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 |
|---|---|
|
Colorectal cancer mortality
大体时间:at least 15 years of follow-up
|
at least 15 years of follow-up
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
All cause mortality
大体时间:at least 15 years of follow-up
|
at least 15 years of follow-up
|
|
colorectal cancer incidence
大体时间:at least 15 years of follow-up
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at least 15 years of follow-up
|
合作者和调查者
调查人员
- 学习椅:Geir Hoff, MD、Sykehuset Telemark
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 (实际的)
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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