Clinical trial NCT05894850: Effect of the Automatic Surveillance System on Surveillance Rate of Colorectal Postpolypectomy Patients
Official title: Effect of the Automatic Surveillance System on Surveillance Rate of Colorectal Postpolypectomy Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Artificial Intelligence
Surveillance
Keywords: surveillance rate
automatic surveillance
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 1644
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: On-time Surveillance Rate
timeFrame: From enrollment to study completion, assessed up to 3 years.
Secondary outcomes:
measure: Surveillance Rate
timeFrame: From enrollment to study completion, assessed up to 3 years.
measure: Advance Surveillance Rate
timeFrame: From enrollment to study completion, assessed up to 3 years.
measure: Delayed Surveillance Rate
timeFrame: From enrollment to study completion, assessed up to 3 years.
measure: The accuracy of identifing post-polypectomy patients
timeFrame: 1 day At the time of enrollment
measure: The accuracy of classifying risk levels
timeFrame: 1 day At the time of enrollment
measure: The accuracy of assigning surveillance intervals
timeFrame: 1 day At the time of enrollment
measure: lesion progression rate
timeFrame: From enrollment to study completion, assessed up to 3 years.
measure: lesion persistence rate
timeFrame: From enrollment to study completion, assessed up to 3 years.
measure: lesion regression rate
timeFrame: From enrollment to study completion, assessed up to 3 years.
measure: The incidence rate of early colorectal cancer
timeFrame: From enrollment to study completion, assessed up to 3 years.
measure: The incidence rate of colorectal cancer
timeFrame: From enrollment to study completion, assessed up to 3 years.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: yuhonggang1969@163.com Yu, phD
role: PRINCIPAL_INVESTIGATOR
References: