Department of Neurosurgery, Strasbourg University Hospital, Strasbourg, France.
Department of Neurosurgery, Strasbourg University Hospital, Strasbourg, France.
J Clin Neurosci. 2022 Jan;95:203-212. doi: 10.1016/j.jocn.2021.11.034. Epub 2021 Dec 18.
A 12-year long, prospective, single center study was conducted, comparing two frameless systems for brain biopsies: ROSA robotic-assisted stereotaxy and BrainLab Varioguide image-guided stereotaxy (Image Guided Surgery, IGS).
All consecutive adult and pediatric patients undergoing frameless brain biopsies were included. Successfully achieving diagnosis was the primary endpoint, analysis of all periprocedural complications was the secondary endpoint, and the tertiary endpoint was the length of the procedure, with the aim of assessing of the learning curve for each operator over time. The results for the ROSA robot and the Varioguide system were compared and benchmarked to data from the literature.
We performed 526 on 516 patients, 314 with the ROSA robot (Group A) and 212 with the IGS Varioguide (Group B). Histological diagnosis was achieved in 97.4% of cases in Group A, versus 93.3% in Group B (p < 0.05). No statistically significant difference was found for secondary and tertiary endpoints. The complication rate appeared similar between the 2 frameless systems, with a hemorrhagic complications rate of 3.5% in Group A and 4.7% in Group B. Permanent neurological deterioration was only recorded in 0.8% of cases from Group B. Mortality was recorded in 0.3% in Group A and 0.4% in Group B.
This study provides evidence to confirm that robotic surgery lives up to its promises of increased safety, accuracy, and reliability.
本研究进行了一项为期 12 年的前瞻性单中心研究,比较了两种无框架系统用于脑活检:ROSA 机器人辅助立体定向和 BrainLab Varioguide 图像引导立体定向(图像引导手术,IGS)。
所有连续的成人和儿科患者均接受无框架脑活检。主要终点是成功获得诊断,次要终点是分析所有围手术期并发症, tertiary 终点是手术过程的长度,目的是评估每个操作者随时间推移的学习曲线。比较了 ROSA 机器人和 Varioguide 系统的结果,并与文献中的数据进行了基准测试。
我们对 516 名患者中的 526 名患者进行了操作,其中 314 名患者使用 ROSA 机器人(A 组),212 名患者使用 IGS Varioguide(B 组)。A 组 97.4%的病例获得了组织学诊断,而 B 组为 93.3%(p<0.05)。次要和 tertiary 终点没有发现统计学上的显著差异。两种无框架系统的并发症发生率似乎相似,A 组出血并发症发生率为 3.5%,B 组为 4.7%。仅在 B 组记录到 0.8%的永久性神经恶化病例。A 组死亡率为 0.3%,B 组为 0.4%。
这项研究提供了证据,证实了机器人手术在提高安全性、准确性和可靠性方面的承诺。