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Clinical Trials/NCT05894850
NCT05894850
Not yet recruiting
Not Applicable

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

Renmin Hospital of Wuhan University1 site in 1 country1,644 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Artificial Intelligence
Sponsor
Renmin Hospital of Wuhan University
Enrollment
1644
Locations
1
Primary Endpoint
On-time Surveillance Rate
Status
Not yet recruiting
Last Updated
2 years ago

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 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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
December 31, 2029
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

On-time Surveillance Rate

Time Frame: 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.

Secondary Outcomes

  • 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.)

Study Sites (1)

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