No Effect of Computer Aided Diagnosis on Colonoscopic Adenoma Detection in a Large Pragmatic Multicenter Randomized Study.

INTRODUCTION Multiple randomized studies have demonstrated that computer-assisted detection (CADe) improves the colonoscopic adenoma detection rate (ADR); however, these improvements have not been consistently reproduced in some more recent studies. METHODS Patients aged ≥50 years undergoing outpatient colonoscopy in 12 German institutions were randomized to either the CADe group or the control group. The primary outcome parameter was the adenoma detection rate (ADR), while secondary outcomes included the adenomas per colonoscopy (APC) rate, detection rates of different histologic subgroups, and adverse events. The median examiner-specific observed rates and examiner-adjusted rates were compared between treatment groups. RESULTS 1627 patients were included (mean age 63.1 years, 39.8% female; 71.% screening indications). The observed median examiner ADR was 40.0% (inter-quartile range IQR 20.0-57.1%) in the study vs. 37.5% (IQR 20.0-50.0%) in the control group. Similarly, adjusted overall ADR was 40.6 % (95%CI: 35.8%, 45.5%) in the study and 38.3% (95%CI: 33.5%, 43.1%) in the control group. No differences were observed in APC or any of the adenoma subgroups with regards to size, morphology, location, and histology as well as colonoscopy indication. The examiner had a large influence on ADR (adjusted median odds ratio/OR 1.32), similar to patient age (OR per 10-years increase 1.40, 95%CI: 1.23, 1.59) and sex (OR 1.62, 95%CI: 1.30, 2.04). On the other hand, more hyperplastic polyps were found by CADe (OR for adjusted HDR = 1.29; 95% CI: 1.02, 1.63; p=0.033). CONCLUSIONS In patients over the age of 50 with mixed colonoscopy indications, CADe did not increase the adenoma detection rate. Further studies should define the requirements for selective CADe use in routine clinical practice, particularly in relation to the examiner's baseline ADR.