Soumpasis Ilias, Nashef Samer, Dunning Joel, Moran Paul, Slack Mark
Cambridge Medical Robotics Surgical Ltd, Cambridge, UK.
Royal Papworth Hospital, Cambridge, UK.
BMJ Surg Interv Health Technol. 2023 Feb 27;5(1):e000144. doi: 10.1136/bmjsit-2022-000144. eCollection 2023.
To describe a new, international, prospective surgical registry developed to accompany the clinical implementation of the Versius Robotic Surgical System by accumulating real-world evidence of its safety and effectiveness.
This robotic surgical system was introduced in 2019 for its first live-human case. With its introduction, cumulative database enrollment was initiated across several surgical specialties, with systematic data collection via a secure online platform.
Pre-operative data include diagnosis, planned procedure(s), characteristics (age, sex, body mass index and disease status) and surgical history. Peri-operative data include operative time, intra-operative blood loss and use of blood transfusion products, intra-operative complications, conversion to an alternative technique, return to the operating room prior to discharge and length of hospital stay. Complications and mortality within 90 days of surgery are also recorded.
The data collected in the registry are analyzed as comparative performance metrics, by meta-analyses or by individual surgeon performance using control method analysis. Continual monitoring of key performance indicators, using various types of analyses and outputs within the registry, have provided meaningful insights that help institutions, teams and individual surgeons to perform most effectively and ensure optimal patient safety.
Harnessing the power of large-scale, real-world registry data for routine surveillance of device performance in live-human surgery from first use will enhance the safety and efficacy outcomes of innovative surgical techniques. Data are crucial to driving the evolution of robot-assisted minimal access surgery while minimizing risk to patients.
CTRI/2019/02/017872.
描述一个新的国际前瞻性手术登记系统，该系统通过积累Versius机器人手术系统安全性和有效性的真实世界证据，来配合其临床应用。
该机器人手术系统于2019年首次用于人体活体手术。随着其引入，在多个外科专业开始了累积数据库登记，并通过安全的在线平台进行系统的数据收集。
术前数据包括诊断、计划手术、特征（年龄、性别、体重指数和疾病状态）及手术史。围手术期数据包括手术时间、术中失血及输血制品使用情况、术中并发症、转为其他手术技术、出院前返回手术室及住院时间。还记录术后90天内的并发症和死亡率。
登记系统收集的数据通过比较性能指标、荟萃分析或使用对照方法分析单个外科医生的表现进行分析。通过登记系统内的各种分析和产出持续监测关键性能指标，提供了有意义的见解，有助于机构、团队和个体外科医生最有效地开展工作，并确保患者获得最佳安全保障。
利用大规模真实世界登记数据的力量对首次用于人体活体手术的设备性能进行常规监测，将提高创新手术技术的安全性和疗效。数据对于推动机器人辅助微创外科手术的发展至关重要，同时将患者风险降至最低。
CTRI/2019/02/0178
