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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05894850
Other study ID # EA-19-003-29
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2029

Study information

Verified date May 2023
Source Renmin Hospital of Wuhan University
Contact Honggang Yu, phD
Phone 13871281899
Email yuhonggang1969@163.com
Is FDA regulated No
Health authority
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 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1644
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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
Manually remind the patients
Medical staff remind patients manually .

Locations

Country Name City State
China Renmin Hospital of Wuhan University Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 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 by automated surveillance system, and the denominator is the number of all enrolled colorectal postpolypectomy patients. 1 day 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. 1 day 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. 1 day 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 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.
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.
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