Comparison between two computer-aided polyp detection colonoscopy systems and High-definition Colonoscopy for Adenomas Detection in Colorectal Cancer Screening: A multi-center randomized control Trial

Phase 3

Completed

• Conditions: Adenoma detection rate Proximal adenoma detection rate Advanced adenoma detection rate Adenoma per colonoscopyProximal adenoma per colonoscopy Advanced adenoma per colonoscopy; colon cancer screening; colonoscopy; Artificial intelligence; adenoma detection rate; polyp

• Registration Number: TCTR20230706006
• Lead Sponsor: ational Research Council of Thailand (NRCT)

Brief Summary

The study enrolled 1200 participants. After adjustment, the ADR and pADR in both intervention groups were significantly higher than in controls. Both CADe systems showed significantly higher APC and pAPC than WLE. AADR and AAPC were improved in both CADe groups versus control, although the differences were not statistically significant.

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-05-31
• Study Start: 2023-07-06
• Results First Posted: 2024-02-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Asymptomatic participants aged 50 to 75 years who had a routine screening colonoscopy or were screened after a positive fecal immunochemical test

Exclusion Criteria

known colorectal cancer history
inflammatory bowel diseases
familial polyposis syndrome
participants who had prior colonic resection
participants with prior pelvic radiation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate at the end of study a colonoscopy with at least one adenoma divided by total number of colonoscopies

Secondary Outcome Measures

Name	Time	Method
proximal adenoma detection rate the end of study number of colonoscopy with at least one adenoma proximal to splenic flexor divided by total number of colonoscopies,Advance adenoma per colonoscopy end of study number of colonoscopy with at least one advance adenoma divided by total number of colonoscopies,adenomas per colonoscopy end of study the total number of adenomatous polyps divided by the total number of the procedure,proximal adenoma per colonoscopy end of study the total number of adenomatous polyps proximal to splenic flexor divided by the total number of the procedure,advanced adenoma per colonoscopy end of study the total number of advance adenomatous polyps divided by the total number of the procedure