Impact of Computer-aided Detection System on the Proximal Adenoma Miss Rate: a Multicenter Tandem Rondomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 686
- 试验地点
- 1
- 主要终点
- Proximal adenoma missed rate
研究概览
简要总结
This is a prospective, multicenter randomized controlled trial designed to determine whether the use of computer-aided detection system could reduce the miss rates of adenomas, SSLs, and polyps in the proximal colon during tandem colonoscopy.
详细描述
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Study Centers 1) Nanfang Hospital, Southern Medical Univerisity, Guangzhou, China 2) The Fifth Affiliated Hospital of Zunyi Medical University, Zhuhai, China 3) Longgang District People's Hospital of Shenzhen, Shenzhen, China 4) Yangjiang People's Hospital, Yangjiang, China 5) Jiangmen Central Hospital, Jiangmen, China 6) Huizhou Third People's Hospital, Huizhou, China 7) Dongguan Shuixiang Central Hospital, Dongguang, China 8) Pingshan District People's Hospital of Shenzhen, Shenzhen, China
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Study population 1) Inclusion criteria:
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Patients age 40-75 years old, regardless of gender
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Patients presenting for physical examination, colorectal cancer screening or diagnosis
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Patients voluntarily signs an informed consent form 2) Exclusion criteria:
- Unable to cooperate ot tolerate colonoscopy
- History of inflammatory bowel disease
- History of colorectal cancer
- Previous colorectal surgery
- History of recurrent constipation
- Taking anticoagulant and antiplatelet drugs berfore procedure
- High risk conditions such as severe cardiovascular and cerebrovascular diseases, severe anemia, or uncorrected infections
- Pregnant or lactating women Researchers concluded that patient was not suitable to participate in this trial.
3) Post-randomization exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients age 40-75 years old, regardless of gender
- •Patients presenting for physical examination, colorectal cancer screening or diagnosis
- •Patients voluntarily signs an informed consent form
排除标准
- •Unable to cooperate ot tolerate colonoscopy
- •History of inflammatory bowel disease
- •History of colorectal cancer
- •Previous colorectal surgery
- •History of recurrent constipation
- •Taking anticoagulant and antiplatelet drugs berfore procedure
- •High risk conditions such as severe cardiovascular and cerebrovascular diseases, severe anemia, or uncorrected infections
- •Pregnant or lactating women Researchers concluded that patient was not suitable to participate in this trial.
结局指标
主要结局
Proximal adenoma missed rate
时间窗: One day
The number of adenomas identified during the second right colon inspection divided by the overall number of adenomas identified during the first and second right colon inspection.
次要结局
- Proximal polyp missed rate(One day)
- Proximal advanced adenoma missed rate(One day)
- Proximal SSLs missed rate(One days)
