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

Renmin Hospital of Wuhan University2 sites in 1 country867 target enrollmentFebruary 26, 2023

ConditionsArtificial Intelligence Surveillance

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Artificial Intelligence
Sponsor: Renmin Hospital of Wuhan University
Enrollment: 867
Locations: 2
Primary Endpoint: surveillance rate
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 26, 2023

End Date

December 31, 2029

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Renmin Hospital of Wuhan University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female aged 18 years or older who undergo colonoscopy.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

surveillance rate

Time Frame: 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.

Secondary Outcomes

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.)