Evaluating the Effect of the Automatic Surveillance System on Surveillance Rate of Colorectal Postpolypectomy Patients

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating the Effect of the Automatic Surveillance System on Surveillance Rate of Colorectal Postpolypectomy Patients: A Prospective, Multicenter Study

Conditions
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Artificial Intelligence, Surveillance

Intervention / Treatment
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* Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS)
* Other: Manually remind the patients to review.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 years or older who undergo colonoscopy. Exclusion Criteria: 1)No pathological result. 2) No or invalid contact information. 3) 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. 4) Has participated in other clinical trials, signed the informed consent form and is in the surveillance period of other clinical trials. 5) 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With automatic surveillance system<br>Patients were reminded of the surveillance time by an automatic surveillance system before the surveillance time. | Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS)<br>* 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 at certain times.<br>|
| Active Comparator: With manual reminder<br>Patients were reminded of the surveillance time manually before the surveillance time. | Other: Manually remind the patients to review.<br>* Medical staff remind patients to review by telephone.<br>|
| No Intervention: Normal group<br>The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surveillance rate | The numerator is the number of patients with surveillance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance. | From enrollment to study completion, assessed up to 3 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Advance Surveillance Rate | The numerator is the number of patients with surveillance in advance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance. | From enrollment to study completion, assessed up to 3 years. | 
| On-time Surveillance Rate | The numerator is the number of patients with on-time surveillance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance. | From enrollment to study completion, assessed up to 3 years. | 
| Delayed Surveillance Rate | The numerator is the number of patients with delayed surveillance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance. | From enrollment to study completion, assessed up to 3 years. | 
| The accuracy of identifing post-polypectomy patients | The numerator is the number of patients correctly identified into post-polypectomy patients, and the denominator is the number of patients undergoing colonoscopy. | At the time of enrollment. | 
| The accuracy of classifying risk levels | The numerator is the number of patients correctly classified by automated surveillance system, and the denominator is the number of all enrolled colorectal postpolypectomy patients. | At the time of enrollment. | 
| The accuracy of assigning surveillance intervals | The numerator is the number of patients correctly assigned by automated surveillance system, and the denominator is the number of all enrolled colorectal postpolypectomy patients. | At the time of enrollment. | 
| lesion progression rate | The numerator is the number of patients with lesion progression, and the denominator is the number of all surveillance colorectal postpolypectomy patients. | From enrollment to study completion, assessed up to 3 years. | 
| lesion persistence rate | The numerator is the number of patients with lesion persistence, and the denominator is the number of all surveillance colorectal postpolypectomy patients. | From enrollment to study completion, assessed up to 3 years. | 
| lesion regression rate | The numerator is the number of patients with lesion regression, and the denominator is the number of all surveillance colorectal postpolypectomy patients. | From enrollment to study completion, assessed up to 3 years. | 
| The incidence rate of colorectal cancer | The numerator is the number of patients with colorectal cancer in surveillance colonoscopy, and the denominator is the number of all surveillance colorectal postpolypectomy patients. | From enrollment to study completion, assessed up to 3 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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surveillance rate, automatic surveillance