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

Not Applicable

Not yet recruiting

• Conditions: Artificial Intelligence; Surveillance
• Interventions: Other: Manually remind the patients; 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.

• Registration Number: NCT05894850
• 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 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

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 Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-31
• Study Start: 2023-06-01
• Study First Submitted QC: 2023-06-07
• Last Update Submitted: 2023-06-07
• Study First Posted: 2023-06-08
• Last Update Posted: 2023-06-08
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1644

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 manual reminder	Manually remind the patients	Patients were reminded of the surveillance time by manual reminder after the endoscopic and pathological results were available and before the surveillance time.
With automatic surveillance system reminding through telephone and message	AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds the patients 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 telephone and message.
With automatic surveillance system reminding through telephone and message	AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds the patients through by telephone .	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.
With automatic surveillance system reminding through message	AI based automatic surveillance (AS) system (ENDOANGEL-AS) reminds the patients 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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary 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.
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.
The incidence rate of early colorectal cancer	From enrollment to study completion, assessed up to 3 years.	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.
The accuracy of identifing post-polypectomy patients	1 day At the time of enrollment	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.
The accuracy of assigning surveillance intervals	1 day 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 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.
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.
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.
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.
The accuracy of classifying risk levels	1 day 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 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.

Trial Locations

Locations (1)

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