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

NCT ID: NCT05894850

Last Updated: 2023-06-08

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

1644 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

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 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

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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.

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 reminding through telephone and message

Patients were reminded of the surveillance time by an automatic surveillance system after the endoscopic and pathological results were available and before the surveillance time through telephone and message.

Group Type EXPERIMENTAL

AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds the patients through by telephone .

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. AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds patients by telephone.

AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds the patients through message.

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. AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds patients through message.

With automatic surveillance system reminding through message

Patients were reminded of the surveillance time by an automatic surveillance system after the endoscopic and pathological results were available and before the surveillance time through message.

Group Type EXPERIMENTAL

AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds the patients through message.

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. AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds patients through message.

With manual reminder

Patients were reminded of the surveillance time by manual reminder after the endoscopic and pathological results were available and before the surveillance time.

Group Type EXPERIMENTAL

Manually remind the patients

Intervention Type OTHER

Medical staff remind patients manually .

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) reminds the patients through by telephone .

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. AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds patients by telephone.

Intervention Type OTHER

AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds the patients through message.

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. AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds patients through message.

Intervention Type OTHER

Manually remind the patients

Medical staff remind patients manually .

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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Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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[email protected] Yu, phD

Role: PRINCIPAL_INVESTIGATOR

Renmin Hospital of Wuhan University

Locations

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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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Yu Honggang, Doctor

Role: primary

13871281899

Other Identifiers

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EA-19-003-29

Identifier Type: -

Identifier Source: org_study_id

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