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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05751824
Enrollment
867
Registered
2023-03-02
Start date
2023-02-26
Completion date
2029-12-31
Last updated
2023-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artificial Intelligence, Surveillance

Keywords

surveillance rate, automatic surveillance

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, group B with manual reminder, and group C with natural state. The surveillance among the three groups were compared.

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.

OTHERManually remind the patients to review.

Medical staff remind patients to review by telephone.

Sponsors

Jiangmen Central Hospital
CollaboratorOTHER
Renmin Hospital of Wuhan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
surveillance rateFrom 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.

Secondary

MeasureTime frameDescription
On-time Surveillance RateFrom 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.
Delayed Surveillance RateFrom 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 identifing post-polypectomy patientsAt the time of enrollment.The numerator is the number of patients correctly identified into post-polypectomy patients, and the denominator is the number of patients undergoing colonoscopy.
The accuracy of classifying risk levelsAt 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.
Advance Surveillance RateFrom 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.
lesion progression rateFrom 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.
lesion persistence rateFrom 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 rateFrom 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.
The incidence rate of colorectal cancerFrom 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.
The accuracy of assigning surveillance intervalsAt 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.

Countries

China

Contacts

Primary ContactHonggang Yu, phD
yuhonggang1969@163.com13871281899

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026