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

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.

Study Overview

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

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 1644
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• China
  • 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: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Experimental: 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.	Other: 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.; 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.
Experimental: 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.	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.
Experimental: 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.	Other: Manually remind the patients; Medical staff remind patients manually .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

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.
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.
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.
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.
The accuracy of identifing post-polypectomy patients	The numerator is the number of patients correctly identified by automated surveillance system, and the denominator is the number of all enrolled colorectal postpolypectomy patients.	1 day 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.	1 day 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.	1 day At the time of enrollment
The incidence rate of early colorectal cancer	The numerator is the number of patients with early 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
• Investigators: Principal Investigator: yuhonggang1969@163.com Yu, phD, Renmin Hospital of Wuhan University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 31, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: surveillance rate; automatic surveillance
• Other Study ID Numbers: EA-19-003-29

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