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

Artificial Intelligence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05751824
• Other study ID #: EA-23-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 26, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: March 2023
• Source: Renmin Hospital of Wuhan University
• Contact: Honggang Yu, phD
• Phone: 13871281899
• Email: yuhonggang1969[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 867
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Artificial Intelligence
• Surveillance

Intervention

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.
• Manually remind the patients to review.
Medical staff remind patients to review by telephone.

Locations

Country	Name	City	State
China	Jiangmen Central Hospital	Jiangmen	Guangdong
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University	Jiangmen Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.