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Not yet recruiting NCT05751824

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

No phase Interventional Artificial Intelligence Surveillance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI based automatic surveillance (AS) system (ENDOANGEL-AS), Manually remind the patients to review..
Who it may be relevant to
Registry conditions: Artificial Intelligence, Surveillance. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other AI based automatic surveillance (AS) system (ENDOANGEL-AS)
    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.
  • Other Manually remind the patients to review.
    Medical staff remind patients to review by telephone.

Primary outcome measures

  • surveillance rate [Time frame: From enrollment to study completion, assessed up to 3 years.]
Secondary outcome measures (10)
  • Advance Surveillance Rate [Time frame: From enrollment to study completion, assessed up to 3 years.]
  • On-time Surveillance Rate [Time frame: From enrollment to study completion, assessed up to 3 years.]
  • Delayed Surveillance Rate [Time frame: From enrollment to study completion, assessed up to 3 years.]
  • The accuracy of identifing post-polypectomy patients [Time frame: At the time of enrollment.]
  • The accuracy of classifying risk levels [Time frame: At the time of enrollment.]
  • The accuracy of assigning surveillance intervals [Time frame: At the time of enrollment.]
  • lesion progression rate [Time frame: From enrollment to study completion, assessed up to 3 years.]
  • lesion persistence rate [Time frame: From enrollment to study completion, assessed up to 3 years.]
  • lesion regression rate [Time frame: From enrollment to study completion, assessed up to 3 years.]
  • The incidence rate of colorectal cancer [Time frame: From enrollment to study completion, assessed up to 3 years.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Screening

Study locations

China · 2 centers
  • Jiangmen Central Hospital — Jiangmen
  • Renmin Hospital of Wuhan University — Wuhan

Identifiers

NCT: NCT05751824 · EA-23-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗