Effect of the Automatic Surveillance System on Surveillance Rate of Colorectal Postpolypectomy Patients
1 other identifier
interventional
1,644
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
June 8, 2023
May 1, 2023
5.6 years
May 31, 2023
June 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Surveillance Rate
From enrollment to study completion, assessed up to 3 years.
Advance Surveillance Rate
From enrollment to study completion, assessed up to 3 years.
Delayed Surveillance Rate
From enrollment to study completion, assessed up to 3 years.
The accuracy of identifing post-polypectomy patients
1 day At the time of enrollment
The accuracy of classifying risk levels
1 day At the time of enrollment
- +6 more secondary outcomes
Study Arms (4)
With automatic surveillance system reminding through telephone and message
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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.
With manual reminder
EXPERIMENTALPatients were reminded of the surveillance time by manual reminder after the endoscopic and pathological results were available and before the surveillance time.
Normal group
NO INTERVENTIONThe patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Male or female aged 18 years or older who undergo colonoscopy.
You may not qualify if:
- )No pathological result.
- \) No or invalid contact information.
- \) 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.
- \) Has participated in other clinical trials, signed the informed consent form and is in the surveillance period of other clinical trials.
- \) Have drug or alcohol abuse or psychological disorder in the past five years.
- ）Pregnancy.
- ）Not suitable for recruitment after investigator evaluation because of other high-risk conditions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
yuhonggang1969@163.com Yu, phD
Renmin Hospital of Wuhan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2023
First Posted
June 8, 2023
Study Start
June 1, 2023
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2029
Last Updated
June 8, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share