Clinical Efficacy Evaluation of a Computer-aided Colonoscopy as Compared With the Standard Colonoscopy.

Colonoscopy is clinically used as the gold standard for detection of colorectal cancer (CRC) and removal of adenomatous polyps of the colon and rectum. Evidence has shown that CRC could be prevented by colonoscopic removal of adenomatous polyps. Despite the success of colonoscopy in reducing cancer-related deaths, there exists a disappointing level of adenomas missed at colonoscopy. In recent years, emerging artificial intelligence (AI) and computer-aided detection (CADe) technology has been shown to improve ADR. Based on a meta-analysis, ADR was demonstrated to be significantly higher in the CADe groups than in the standard colonoscopy groups, representing a relative risk of 25.2%. In this study, performance of colonoscopy with or without aid of CADe will be compared in terms of quality indicators. The adenoma detection rate (ADR), which is the proportion of average-risk patients undergoing screening colonoscopy in whom an adenoma is found, is regarded as a robust measure of colonoscopy performance quality that correlates with subsequent cancer risk. Thus, ADR is taken as the primary outcome of this study. The target population includes individuals who are undergoing screening, diagnostic, or surveillance colonoscopy.

Sex

All

Minimum age

40 Years

Maximum age

80 Years

Inclusion Criteria:

* Subjects who have given signed informed consent form
* Informed consensus has been obtained that endoscopic resection should be performed if a lesion is found
* Subjects who are scheduled for screening or diagnostic colonoscopy for colorectal cancer (CRC) or surveillance colonoscopy for post-polypectomy follow-up

Exclusion Criteria:

* Subjects with any of the following prior history or current conditions:

  1. Contraindications to colonoscopy
  2. Inflammatory bowel disease (IBD)
  3. Colorectal cancer (CRC)
  4. Familial adenomatous polyposis (FAP)
  5. Colonic stenosis
  6. Severe organ failure (cirrhosis of Child C, heart failure of ACC / AHA stage D)
  7. Active gastrointestinal (GI) Bleeding
  8. Pregnancy
  9. Prior colorectal surgery, including colonic or rectal resection (except for appendectomy, surgery on the anus, and polypectomy)
  10. Undergo colonoscopy within 3 years
* Subjects with any of the following conditions per the investigator's judgement:

  1. High suspicion of IBD, CRC, and FAP.
  2. High risk of bleeding after endoscopic treatment, and difficult management of anticoagulation or antiplatelet medication.