Effect of the Automatic Surveillance System on Surveillance Rate of Colorectal Postpolypectomy Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,644
- 试验地点
- 1
- 主要终点
- On-time 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 reminding though telephone and message, group B with intelligent surveillance system reminding though message, group C with manual reminder, and group D with natural state. The surveillance among the four groups were compared.
详细描述
The adherence of doctors to published colorectal post-polypectomy surveillance guidelines varies greatly, and patient follow-up is critical but time-consuming. Previous studies we developed an automatic surveillance (AS) system to accurately identify post-polypectomy patients, assign surveillance intervals for different risks of patients and proactively follow up with patients in time. 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 reminding though telephone and message, group B with intelligent surveillance system reminding though message, group C with manual reminder, and group D with natural state. The surveillance among the four 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 reminding through telephone and message
Patients were reminded of the surveillance time by an automatic surveillance system after the endoscopic and pathological results were available and before the surveillance time through telephone and message.
干预措施: AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds the patients through by telephone . (Other)
With automatic surveillance system reminding through telephone and message
Patients were reminded of the surveillance time by an automatic surveillance system after the endoscopic and pathological results were available and before the surveillance time through telephone and message.
干预措施: AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds the patients through message. (Other)
With automatic surveillance system reminding through message
Patients were reminded of the surveillance time by an automatic surveillance system after the endoscopic and pathological results were available and before the surveillance time through message.
干预措施: AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds the patients through message. (Other)
With manual reminder
Patients were reminded of the surveillance time by manual reminder after the endoscopic and pathological results were available and before the surveillance time.
干预措施: Manually remind the patients (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
On-time Surveillance Rate
时间窗: From enrollment to study completion, assessed up to 3 years.
The numerator is the number of patients with on-time surveillance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance.
次要结局
- Surveillance Rate(From enrollment to study completion, assessed up to 3 years.)
- lesion progression rate(From enrollment to study completion, assessed up to 3 years.)
- The incidence rate of early colorectal cancer(From enrollment to study completion, assessed up to 3 years.)
- The accuracy of identifing post-polypectomy patients(1 day At the time of enrollment)
- The accuracy of assigning surveillance intervals(1 day At the time of enrollment)
- lesion persistence rate(From enrollment to study completion, assessed up to 3 years.)
- lesion regression rate(From enrollment to study completion, assessed up to 3 years.)
- Advance Surveillance Rate(From enrollment to study completion, assessed up to 3 years.)
- Delayed Surveillance Rate(From enrollment to study completion, assessed up to 3 years.)
- The accuracy of classifying risk levels(1 day At the time of enrollment)
- The incidence rate of colorectal cancer(From enrollment to study completion, assessed up to 3 years.)