Explore the Relationship Between the Percentage of Colonoscopy Withdrawal Overspeed and the Adenoma Detection Rate: a Prospective, Multicenter, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- The percentage of colonoscopy withdrawal overspeed
研究概览
简要总结
In this study, the investigators used the optical flow method to measure the colonoscopy withdrawal speed, and doctors were selected from multiple hospitals to collect prospective colonoscopy screening videos, and the percentage of colonoscopy withdrawal overspeed was calculated to explore the relationship between it based on optical flow method and the adenoma detection rate.
详细描述
Study showed that adequate withdrawal time is an important prerequisite for full mucosal inspection. In a large population-based analysis, a 1-min increase in withdrawal time led to a 3.6% increase in the ADR. Protocols or expert consensus recommend a standard withdrawal time of 6 min or longer. However, Findings of studies showed that a number of colonoscopies had a withdrawal time less than 6 min, which greatly reduces the ADR.
Investigator's preliminary experiments have shown that deep learning can monitor the colonoscopy withdrawal time in real-time and improve the adenoma detection rate. Based on the above rich foundation of preliminary work and the massive demand for improving the colonoscopy withdrawal assessment system.
The investigators improved EndoAngel to use optical flow method to monitor the colonoscopy withdrawal speed. The performance of the EndoAngel system was verified in colonoscopy videos. The investigators then aimed to evaluate whether the EndoAngel system could improve polyp detection rate after restricting the colonoscopy withdrawal speed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years old;
- •Able to read, understand and sign an informed consent;
- •The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures;
- •Patients requiring screening colonoscopy.
排除标准
- •Have drug or alcohol abuse or mental disorder in the last 5 years;
- •Pregnant or lactating women;
- •Patients with known multiple polyp syndrome;
- •patients with known inflammatory bowel disease;
- •known intestinal stenosis or space-occupying tumor;
- •known colon obstruction or perforation;
- •patients with a history of colorectal surgery;
- •Patients with a previous history of allergy to pre-used spasmolysis;
- •Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants;
- •High-risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.
结局指标
主要结局
The percentage of colonoscopy withdrawal overspeed
时间窗: A month
The percentage of colonoscopy withdrawal overspeed was calculated by dividing the time of colonoscopy withdrawal overspeed by the total time of colonoscopy withdrawal.
The adenoma detection rate (ADR)
时间窗: A month
ADR was calculated by dividing the total number of patients being detected adenomas by the number of colonoscopies.
次要结局
- The mean number of polyps per patient (MNP)(A month)
- colonoscopy forward time(A month)
- The mean number of adenomas per patient (MAP)(A month)
- The polyp detection rate (PDR)(A month)
- colonoscopy withdrawal time(A month)