Pafitanis Georgios, Hadjiandreou Michalis, Alamri Alexander, Uff Christopher, Walsh Daniel, Myers Simon
Group for Academic Plastic Surgery, Microvascular Anastomosis Simulation Hub, The Blizard Institute, Queen Mary University of London, London, UK.
Department of Plastic Surgery, Great Ormond Street Hospital for Children Foundation Trust, London, UK.
Arch Plast Surg. 2020 May;47(3):242-249. doi: 10.5999/aps.2019.01473. Epub 2020 May 15.
The Exoscope is a novel high-definition digital camera system. There is limited evidence signifying the use of exoscopic devices in microsurgery. This trial objectively assesses the effects of the use of the Exoscope as an alternative to the standard operating microscope (OM) on the performance of experts in a simulated microvascular anastomosis.
Modus V Exoscope and OM were used by expert microsurgeons to perform standardized tasks. Hand-motion analyzer measured the total pathlength (TP), total movements (TM), total time (TT), and quality of end-product anastomosis. A clinical margin of TT was performed to prove non-inferiority. An expert performed consecutive microvascular anastomoses to provide the exoscopic learning curve until reached plateau in TT.
Ten micro sutures and 10 anastomoses were performed. Analysis demonstrated statistically significant differences in performing micro sutures for TP, TM, and TT. There was statistical significance in TM and TT, however, marginal non-significant difference in TP regarding microvascular anastomoses performance. The intimal suture line analysis demonstrated no statistically significant differences. Non-inferiority results based on clinical inferiority margin (Δ) of TT=10 minutes demonstrated an absolute difference of 0.07 minutes between OM and Exoscope cohorts. A 51%, 58%, and 46% improvement or reduction was achieved in TT, TM, TP, respectively, during the exoscopic microvascular anastomosis learning curve.
This study demonstrated that experts' Exoscope anastomoses appear non-inferior to the OM anastomoses. Exoscopic microvascular anastomosis was more time consuming but end-product (patency) in not clinically inferior. Experts' "warm-up" learning curve is steep but swift and may prove to reach clinical equality.
外视镜是一种新型高清数码相机系统。关于在显微手术中使用外视镜设备的证据有限。本试验客观评估了使用外视镜替代标准手术显微镜（OM）对模拟微血管吻合术中专家操作的影响。
显微外科专家使用Modus V外视镜和OM执行标准化任务。手动运动分析仪测量总路径长度（TP）、总运动次数（TM）、总时间（TT）以及最终产品吻合的质量。进行TT的临床差值分析以证明非劣效性。一名专家连续进行微血管吻合以提供外视镜学习曲线，直至TT达到平稳状态。
进行了10次显微缝合和10次吻合。分析表明，在进行显微缝合时，TP、TM和TT存在统计学显著差异。在TM和TT方面存在统计学意义，但在微血管吻合操作的TP方面存在边缘性非显著差异。内膜缝合线分析显示无统计学显著差异。基于TT = 10分钟的临床劣效性差值（Δ）的非劣效性结果表明，OM组和外视镜组之间的绝对差值为0.07分钟。在外视镜微血管吻合学习曲线期间，TT、TM、TP分别提高或降低了51%、58%和46%。
本研究表明，专家使用外视镜进行的吻合似乎不劣于使用OM进行的吻合。外视镜微血管吻合耗时更长，但最终产品（通畅率）在临床上并不逊色。专家的“热身”学习曲线陡峭但迅速，可能会达到临床等效性。
