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

NCT ID: NCT05751824

Last Updated: 2023-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

867 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-26

Study Completion Date

2029-12-31

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.

Detailed Description

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Conditions

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Artificial Intelligence Surveillance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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With automatic surveillance system

Patients were reminded of the surveillance time by an automatic surveillance system before the surveillance time.

Group Type EXPERIMENTAL

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

Intervention Type 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.

With manual reminder

Patients were reminded of the surveillance time manually before the surveillance time.

Group Type ACTIVE_COMPARATOR

Manually remind the patients to review.

Intervention Type OTHER

Medical staff remind patients to review by telephone.

Normal group

The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Manually remind the patients to review.

Medical staff remind patients to review by telephone.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangmen Central Hospital

OTHER

Sponsor Role collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Honggang Yu, phD

Role: PRINCIPAL_INVESTIGATOR

Renmin Hospital of Wuhan University

Locations

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Jiangmen Central Hospital

Jiangmen, Guangdong, China

Site Status

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status

Countries

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China

Central Contacts

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Honggang Yu, phD

Role: CONTACT

13871281899

Facility Contacts

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Guoen Lv, Doctor

Role: primary

13536123479

Yu Honggang, Doctor

Role: primary

13871281899

Other Identifiers

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EA-23-01

Identifier Type: -

Identifier Source: org_study_id

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