NCT04901130Unknown不适用
Impact of Real-time Automatic Quality Control System on Colorectal Adenoma Detection: a Multicenter Randomized Controlled Trial
Shandong University6 个研究点 分布在 1 个国家目标入组 1,254 人开始时间: 2021年5月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,254
- 试验地点
- 6
- 主要终点
- Colorectal adenoma detection rate (ADR)
研究概览
简要总结
The purpose of this study was to assess the performance of automatic quality-control system (AQCS) in real-time quality control of colonoscopy.
详细描述
We carried a multicenter randomised controlled trial to assess the performance of this system in quality control of real-time colonoscopy, including the adenoma detection rate (ADR), withdraw time, adequate bowel preparation rate and other indicators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients (aged 18-80 years) scheduled for colonoscopy examination.
排除标准
- •Patients with a history of inflammatory bowel disease, advanced colorectal cancer, polyposis syndromes or known colorectal polyps without complete removal previously.
- •Patients with a history of colorectal surgery.
- •Patients with a contraindication for biopsy.
- •Patients with prior failed colonoscopy.
- •Patients with known stenosis or obstruction.
- •Patients in pregnancy or lactation phase.
- •Patients refused to participate in the trial.
结局指标
主要结局
Colorectal adenoma detection rate (ADR)
时间窗: 10 months
The primary endpoint is the adenoma detection rate (ADR), which is the proportion of patients having one or more adenomas detected by colonoscopy.
次要结局
- The mean number of adenomas detected per colonoscopy (APC)(10 months)
- Colorectal polyp detection rate (PDR)(10 months)
- The mean number of polyps detected per colonoscopy (PPC)(10months)
- Withdrawl time(During procedure)
研究者
Yanqing Li
Vice president of Qilu Hospital
Shandong University
研究点 (6)
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