Evaluating the Effect of the Automatic Surveillance System on Surveillance Rate of Colorectal Postpolypectomy Patients: A Prospective, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 867
- 试验地点
- 2
- 主要终点
- surveillance rate
研究概览
简要总结
In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of colorectal postpolypectomy patients. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups were compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
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 aged 18 years or older who undergo colonoscopy.
排除标准
- •No pathological result.
- •No or invalid contact information.
- •The surveillance interval cannot be determined according to the surveillance guidelines, including poor bowel preparation, colorectal cancer or suspicious malignance, surgery or colorectal ESD history, those who fail to complete colonoscopy due to unbearable, pathological indications of not polyps, hamartoma or lymphoma polyps, history of ulcerative colitis, and so on.
- •Has participated in other clinical trials, signed the informed consent form and is in the surveillance period of other clinical trials.
- •Have drug or alcohol abuse or psychological disorder in the past five years.
- •6）Pregnancy.
- •7）Not suitable for recruitment after investigator evaluation because of other high-risk conditions.
研究组 & 干预措施
With automatic surveillance system
Patients were reminded of the surveillance time by an automatic surveillance system before the surveillance time.
干预措施: AI based automatic surveillance (AS) system (ENDOANGEL-AS) (Other)
With manual reminder
Patients were reminded of the surveillance time manually before the surveillance time.
干预措施: Manually remind the patients to review. (Other)
Normal group
The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder.
结局指标
主要结局
surveillance rate
时间窗: From enrollment to study completion, assessed up to 3 years.
The numerator is the number of patients with surveillance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance.
次要结局
- lesion regression rate(From enrollment to study completion, assessed up to 3 years.)
- The accuracy of identifing post-polypectomy patients(At the time of enrollment.)
- The incidence rate of colorectal cancer(From enrollment to study completion, assessed up to 3 years.)
- Advance Surveillance Rate(From enrollment to study completion, assessed up to 3 years.)
- On-time Surveillance Rate(From enrollment to study completion, assessed up to 3 years.)
- The accuracy of classifying risk levels(At the time of enrollment.)
- The accuracy of assigning surveillance intervals(At the time of enrollment.)
- lesion progression rate(From enrollment to study completion, assessed up to 3 years.)
- Delayed Surveillance Rate(From enrollment to study completion, assessed up to 3 years.)
- lesion persistence rate(From enrollment to study completion, assessed up to 3 years.)