Automatic Quality Control System and Adenoma Detection Rates During Routine Colonoscopy: A Randomized Clinical Trial

Abstract

Importance: High-quality colonoscopy reduces the risks of colorectal cancer by increasing the adenoma detection rate. Routine use of an automatic quality control system (AQCS) to assist in colorectal adenoma detection should be considered.

Objective: To evaluate the effect of an AQCS on the adenoma detection rate among colonoscopists who were moderate- and low-level detectors during routine colonoscopy.

Design, setting, and participants: This multicenter, single-blind, randomized clinical trial was conducted at 6 centers in China from August 1, 2021, to September 30, 2022. Data were analyzed from March 1 to June 30, 2023. Individuals aged 18 to 80 years were enrolled. Exclusion criteria were a history of inflammatory bowel disease, advanced colorectal cancer, and polyposis syndromes; known colorectal polyps without complete removal previously; a history of colorectal surgery; known stenosis or obstruction with contraindication for biopsy or prior failed colonoscopy; pregnancy or lactation; and refusal to participate. Intention-to-treat and per-protocol analysis was used.

Interventions: Standard colonoscopy or AQCS-assisted colonoscopy.

Main outcomes and measures: Adenoma detection rate.

Results: A total of 1254 participants (mean [SD] age, 51.21 [12.10] years; 674 [53.7%] male) were randomized (627 standard colonoscopy, 627 AQCS-assisted colonoscopy). Intention-to-treat analysis showed a significantly higher adenoma detection rate in the AQCS-assisted group vs standard colonoscopy group (32.7% vs 22.6%; relative risk [RR], 1.60; 95% CI, 1.23-2.09; P < .001). The adenoma detection rates were significantly higher in the AQCS group when considering pathology (nonadvanced adenomas, 30.1% vs 21.2%; RR, 1.52; 95% CI, 1.16-1.99; P = .002), and morphology (flat or sessile, 29.3% vs 20.4%, RR, 1.52; 95% CI, 1.16-2.00; P = .003). Use of AQCS significantly increased the adenoma detection rate of both the lower-level detectors (30.0% vs 20.0%; RR, 1.71; 95% CI, 1.24-2.35; P = .001) and the medium-level detectors (38.1% vs 27.7%; RR, 1.61; 95% CI, 1.07-2.43; P = .02). Similar increases were found for adenoma detection rates in the academic and nonacademic centers (academic: 29.3% vs 20.8%; RR, 1.58; 95% CI, 1.10-2.29; P = .01; nonacademic: 36.1% vs 24.5%; RR, 1.74; 95% CI, 1.23-2.46; P = .002). The number of adenomas per colonoscopy was significantly higher in the AQCS-assisted group (0.86 vs 0.48; RR, 1.50; 95% CI, 1.17-1.91; P = .001). The mean withdrawal time without intervention was slightly increased with AQCS assistance (6.78 vs 6.46 minutes; RR, 1.38; 95% CI, 1.26-1.52; P < .001). No serious adverse events were reported.

Conclusions and relevance: In this randomized clinical trial, AQCS assistance during routine colonoscopy increased adenoma detection rates and several related polyp parameters compared with standard colonoscopy in the lower- and medium-level detectors in academic and nonacademic settings. Routine use of AQCS to assist in colorectal adenoma detection and quality improvement should be considered.

Trial registration: ClinicalTrials.gov Identifier: NCT04901130.

Figure 1.. Patient Flowchart

AQCS indicates automatic quality control system.

Figure 2.. Comparison of the Adenoma Detection Rate Between Automatic Quality Control System (AQCS) and Standard Colonoscopy (SC) Groups According to Intention-to-Treat Analysis

RR indicates relative risk. The sizes of the boxes represent the magnitude of the SE. ^aSessile serrated lesion was not included in the detection rate of adenoma. Data available for 209 patients in each group. ^bPolyps with histologic testing showing hyperplastic, inflammatory lesions, normal mucosa, and others.