Performance comparison of reusable versus disposable colonoscopes：a non-inferiority Trial

ObjectiveWe herein compared the performance of reusable and disposable colonoscopes in patients scheduled to undergo colonoscopy with a view of preventing patient cross-infection, protecting the safety of clinical medical staff, reducing the risk of infection, and minimizing the decontamination process, particularly during the coronavirus disease 2019 pandemic. MethodsWe randomly divided patients meeting the enrollment criteria into reusable and disposable colonoscopy groups; the success rate of photographing customary anatomical sites with a non-inferiority margin of -8% was the primary endpoint. Secondary endpoints were the adenoma detection rate, operation time, endoscopic image quality score, endoscopic mucosal resection (EMR) success rate, and adverse events. ResultsWe recruited patients who were treated using reusable or disposable (n = 45, each) colonoscopes. Both groups had 100% success rate for capturing images of customary anatomical sites, with no between-group differences. The lower limit of 95% CI was - 7.8654%, which was greater than the non-inferiority threshold of -8%. The disposable group had a significantly lower average image quality score (26.09 {+/-}1.33 vs. 27.44{+/-}0.59, P < 0.001) than the reusable group. The groups did not significantly differ in maneuverability, safety, or device failure/defect rate. The en-bloc EMR success rate was 100% in both groups. EMR took significantly longer in the disposable group (466.18 s{+/-}180.56 s vs. 206.32 s{+/-}109.54 s, P < 0.001). The incidence of EMR-related bleeding and perforation did not significantly differ between the groups. ConclusionsDisposable colonoscope endoscopy is safe and feasible for endoscopy examinations and EMR.