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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Artificial Intelligence; Surveillance
• Intervention / Treatment: Other: AI based automatic surveillance (AS) system (ENDOANGEL-AS); Other: Manually remind the patients to review.

• Study Type: Interventional
• Enrollment (Anticipated): 867
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Honggang Yu, PhD; Phone Number: 13871281899; Email: yuhonggang1969@163.com

Study Locations

• China
  • Guangdong
    • Jiangmen, Guangdong, China, 529000
      • Jiangmen Central Hospital
      • Contact: Guoen Lv, Doctor; Phone Number: 13536123479; Email: lvrock@163.com
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
      • Contact: Yu Honggang, Doctor; Phone Number: 13871281899; Email: yuhonggang@whu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: With automatic surveillance system; Patients were reminded of the surveillance time by an automatic surveillance system before the surveillance time.	Other: 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.
Active Comparator: With manual reminder; Patients were reminded of the surveillance time manually before the surveillance time.	Other: Manually remind the patients to review.; Medical staff remind patients to review by telephone.
No Intervention: Normal group; The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surveillance rate	The numerator is the number of patients with surveillance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance.	From enrollment to study completion, assessed up to 3 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Advance Surveillance Rate	The numerator is the number of patients with surveillance in advance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance.	From enrollment to study completion, assessed up to 3 years.
On-time Surveillance Rate	The numerator is the number of patients with on-time surveillance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance.	From enrollment to study completion, assessed up to 3 years.
Delayed Surveillance Rate	The numerator is the number of patients with delayed surveillance, and the denominator is the number of all colorectal postpolypectomy patients requiring surveillance.	From enrollment to study completion, assessed up to 3 years.
The accuracy of identifing post-polypectomy patients	The numerator is the number of patients correctly identified into post-polypectomy patients, and the denominator is the number of patients undergoing colonoscopy.	At the time of enrollment.
The accuracy of classifying risk levels	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.	At the time of enrollment.
The accuracy of assigning surveillance intervals	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.	At the time of enrollment.
lesion progression rate	The numerator is the number of patients with lesion progression, and the denominator is the number of all surveillance colorectal postpolypectomy patients.	From enrollment to study completion, assessed up to 3 years.
lesion persistence rate	The numerator is the number of patients with lesion persistence, and the denominator is the number of all surveillance colorectal postpolypectomy patients.	From enrollment to study completion, assessed up to 3 years.
lesion regression rate	The numerator is the number of patients with lesion regression, and the denominator is the number of all surveillance colorectal postpolypectomy patients.	From enrollment to study completion, assessed up to 3 years.
The incidence rate of colorectal cancer	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.	From enrollment to study completion, assessed up to 3 years.

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University
• Collaborators: Jiangmen Central Hospital
• Investigators: Principal Investigator: Honggang Yu, PhD, Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 26, 2023
• Primary Completion (Anticipated): December 31, 2028
• Study Completion (Anticipated): December 31, 2029

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: surveillance rate; automatic surveillance
• Other Study ID Numbers: EA-23-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No