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NCT Number: NCT05751824

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

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.

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Key information

Conditions

Artificial Intelligence Surveillance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jiangmen Central Hospital, Jiangmen, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI based automatic surveillance (AS) system (ENDOANGEL-AS)

Other

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.

Manually remind the patients to review.

Other

Medical staff remind patients to review by telephone.

Primary outcomes

  1. 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

  1. Advance Surveillance Rate

    Time frame: From enrollment to study completion, assessed up to 3 years.

    The numerator is the number of patients with surveillance in advance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance.

  2. 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.

  3. Delayed Surveillance Rate

    Time frame: From enrollment to study completion, assessed up to 3 years.

    The numerator is the number of patients with delayed surveillance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance.

  4. The accuracy of identifing post-polypectomy patients

    Time frame: At the time of enrollment.

    The numerator is the number of patients correctly identified into post-polypectomy patients, and the denominator is the number of patients undergoing colonoscopy.

  5. The accuracy of classifying risk levels

    Time frame: At the time of enrollment.

    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.

  6. The accuracy of assigning surveillance intervals

    Time frame: At the time of enrollment.

    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.

  7. lesion progression rate

    Time frame: From enrollment to study completion, assessed up to 3 years.

    The numerator is the number of patients with lesion progression, and the denominator is the number of all surveillance colorectal postpolypectomy patients.

  8. lesion persistence rate

    Time frame: From enrollment to study completion, assessed up to 3 years.

    The numerator is the number of patients with lesion persistence, and the denominator is the number of all surveillance colorectal postpolypectomy patients.

  9. lesion regression rate

    Time frame: From enrollment to study completion, assessed up to 3 years.

    The numerator is the number of patients with lesion regression, and the denominator is the number of all surveillance colorectal postpolypectomy patients.

  10. The incidence rate of colorectal cancer

    Time frame: From enrollment to study completion, assessed up to 3 years.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Honggang Yu, phD

CONTACT

[email protected]

13871281899

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Collaborators

  • Jiangmen Central Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Mar 2, 2023
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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