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

Not Applicable

Not yet recruiting

• Conditions: Artificial Intelligence; Surveillance
• Interventions: Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS); Other: Manually remind the patients to review.

• Registration Number: NCT05751824
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2022-11-07
• Study Start: 2023-02-26
• Study First Submitted QC: 2023-02-27
• Status Verified: 2023-03
• Study First Posted: 2023-03-02
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 867

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With automatic surveillance system	AI based automatic surveillance (AS) system (ENDOANGEL-AS)	Patients were reminded of the surveillance time by an automatic surveillance system before the surveillance time.
With manual reminder	Manually remind the patients to review.	Patients were reminded of the surveillance time manually before the surveillance time.

Primary Outcome Measures

Name	Time	Method
surveillance rate	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 Outcome Measures

Name	Time	Method
lesion regression rate	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.
The accuracy of identifing post-polypectomy patients	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.
The incidence rate of colorectal cancer	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.
Advance Surveillance Rate	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.
On-time Surveillance Rate	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.
The accuracy of classifying risk levels	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.
The accuracy of assigning surveillance intervals	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.
lesion progression rate	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.
Delayed Surveillance Rate	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.
lesion persistence rate	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.

Trial Locations

Locations (2)

Jiangmen Central Hospital; 🇨🇳 Jiangmen, Guangdong, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China