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临床试验/NCT07308743
NCT07308743尚未招募不适用

Impact of Computer-aided Detection System on the Proximal Adenoma Miss Rate: a Multicenter Tandem Rondomized Controlled Trial

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 686 人开始时间: 2025年12月1日最近更新:

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

  1. 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

  2. Study population 1) Inclusion criteria:

  3. Patients age 40-75 years old, regardless of gender

  4. Patients presenting for physical examination, colorectal cancer screening or diagnosis

  5. Patients voluntarily signs an informed consent form 2) Exclusion criteria:

  1. Unable to cooperate ot tolerate colonoscopy
  2. History of inflammatory bowel disease
  3. History of colorectal cancer
  4. Previous colorectal surgery
  5. History of recurrent constipation
  6. Taking anticoagulant and antiplatelet drugs berfore procedure
  7. High risk conditions such as severe cardiovascular and cerebrovascular diseases, severe anemia, or uncorrected infections
  8. 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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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