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

Wuhan University

Status: Not yet enrolling

Conditions: Surveillance; Artificial Intelligence

Treatments: Other: Manually remind the patients to review.; Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05751824

EA-23-01

Details and patient eligibility

About

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.

Enrollment: 867 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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867 participants in 3 patient groups

With automatic surveillance system

Experimental group

Description:

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

Treatment:

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

With manual reminder

Active Comparator group

Description:

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

Treatment:

Other: Manually remind the patients to review.

Normal group

No Intervention group

Description:

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