An investigation of post-market early-stage research designs between two generations of da Vinci and versius : Focus on prospective studies and adverse event analysis

Author

Suzuki, Hiroyuki and Hattori, Kaoru and Iwasaki, Kiyotaka

Abstract

Introduction : Adverse events in robot-assisted surgery (RAS) are multifaceted and influenced by both technical and human factors. This study aims to provide insights into post-market clinical study design for therapeutic devices in RAS by comparing early-stage research design on two generations of da Vinci and Versius, focusing on prospective studies, adverse event analysis, and levels of evidence. Methods : A comparative analysis was conducted using data from clinical studies and reports involving da Vinci and Versius in the post-market early stage. We compared the ratios of prospective studies, evaluated the inclusion of adverse event analysis, and assessed the level of evidence using a critical appraisal tool. Results : The study revealed a significant increase in prospective studies (22.7％ vs. 76.9％, p＝0.0002) and adverse event analysis (0％ vs. 15.4％, p＝0.0040) for Versius compared to da Vinci. In addition to analyzing adverse events by severity, two studies on Versius provide a detailed analysis of the association between devices and/or user error. Versius achieved Level 3 evidence earlier and in more studies than da Vinci. Discussion : The findings suggest that research designs in RAS have improved in prospective studies, adverse event analysis, and evidence levels. Evaluating the impact of technical and human factors is crucial in RAS for improving patient safety and ensuring the timely provision of information on the proper use and improvements of medical devices. Conclusion : The research design of post-market clinical studies in RAS reflects a shift towards higher-quality evidence, enhancing safety and effectiveness. Evaluating prospective studies in the post-market early stage of RAS, considering human factors, may lead to improved therapeutic efficacy and safety.