CMR Surgical, Cambridge, UK.
Royal Papworth Hospital, Cardiac Surgery Department, Cambridge Biomedical Campus, Cambridge, UK.
Ann Surg. 2023 Oct 1;278(4):e903-e910. doi: 10.1097/SLA.0000000000005871. Epub 2023 Apr 10.
To present the first report of data from the Versius Surgical Registry, a prospective, multicenter data registry with ongoing collection across numerous surgical indications, developed to accompany the Versius Robotic Surgical System into clinical practice.
A data registry can be utilized to minimize risk to patients by establishing the safety and effectiveness of innovative medical devices and generating a thorough evidence base of real-world data.
Surgical outcome data were collected and inputted through a secure online platform. Preoperative data included patient age, sex, body mass index, surgical history, and planned procedures. Intraoperative data included operative time, complications during surgery, conversion from robot-assisted surgery to an alternative surgical technique, and blood loss. Postoperative outcome data included length of hospital stay, complications following surgery, serious adverse events, return to the operating room, readmission to the hospital, and mortality within 90 days of surgery.
This registry analysis included 2083 cases spanning general, colorectal, hernia, gynecologic, urological, and thoracic indications. A considerable number of cases were recorded for cholecystectomy (n=539), anterior resection (n=162), and total laparoscopic hysterocolpectomy (n=324) procedures. The rates of conversion to an alternative technique, serious adverse events, and 90-day mortality were low for all procedures across all surgical indications.
We report the large-scale analysis of the first 2083 cases recorded in this surgical registry, with substantial data collected for cholecystectomies, anterior resections, and total laparoscopic hysterectomies. The extensive surgical outcome data reported here provide real-world evidence for the safe implementation of the surgical robot into clinical practice.
介绍 Versius 手术注册中心的首批数据报告。该注册中心是一个前瞻性、多中心的数据注册中心，持续收集多个手术适应证的数据，旨在伴随 Versius 机器人手术系统进入临床实践。
数据注册中心可用于通过确定创新医疗器械的安全性和有效性来最小化患者风险，并生成真实世界数据的全面证据基础。
通过安全的在线平台收集和输入手术结果数据。术前数据包括患者年龄、性别、体重指数、手术史和计划手术。术中数据包括手术时间、手术期间的并发症、将机器人辅助手术转换为替代手术技术、以及失血量。术后结果数据包括住院时间、手术后并发症、严重不良事件、重返手术室、再次住院以及手术后 90 天内的死亡率。
本注册分析包括 2083 例涵盖普外科、结直肠科、疝科、妇科、泌尿科和胸外科适应证的病例。胆囊切除术（n=539）、前切除术（n=162）和全腹腔镜子宫切除术（n=324）的病例数量较多。所有手术适应证的所有手术中，转换为替代技术、严重不良事件和 90 天死亡率的发生率都较低。
我们报告了这个手术注册中心的前 2083 例的大规模分析，其中胆囊切除术、前切除术和全腹腔镜子宫切除术的数据采集量较大。这里报告的广泛手术结果数据为机器人手术安全应用于临床实践提供了真实世界的证据。
