目的:经口机器人手术在口咽病理学的治疗模式中已经确立。Versius手术系统(CMRSurgical)是一种用于多种专业临床的机器人平台,但目前尚未在头部和颈部进行测试。这项研究利用手术创新的理想框架来前瞻性地评估和报告Versius的人类临床经验和单中心病例系列经口机器人手术(TORS)。
方法:在理想框架阶段1和2a之后,该研究评估了Versius在从良性病例过渡到恶性病例之前在人类TORS中的表现。对系统设置进行了迭代调整,仪器仪表,和技术,按照理想的建议记录。评估标准包括成功完成程序,设置时间,手术时间,并发症,主观印象。对进行四臂手术的系统进行了进一步评估。
结果:成功完成了30个TORS程序(15个良性,15恶性),无术中并发症或转换为开放手术。设置时间在研究期间显著减少。确定了仪器挑战,敦促需要针对TORS的特定工具。这项研究引入了四臂手术,展示Versius的独特能力,尽管观察到远端通路的局限性。
结论:使用Versius手术系统是可行的。TORS专用仪器的开发将有利于性能和系统的更广泛采用。4臂手术是可能的,但需要进一步评估。建议进行多中心评估(IDEAL阶段2b)。
OBJECTIVE: Transoral robotic surgery is well established in the treatment paradigm of oropharyngeal pathology. The Versius Surgical System (CMR Surgical) is a robotic platform in clinical use in multiple specialities but is currently untested in the head and neck. This study utilises the IDEAL framework of surgical innovation to prospectively evaluate and report a first in human clinical experience and single centre
case series of transoral robotic surgery (TORS) with Versius.
METHODS: Following IDEAL framework stages 1 and 2a, the study evaluated Versius to perform first in human TORS before transitioning from benign to malignant cases. Iterative adjustments were made to system setup, instrumentation, and technique, recorded in accordance with IDEAL recommendations. Evaluation criteria included successful procedure completion, setup time, operative time, complications, and subjective impressions. Further evaluation of the system to perform four-arm surgery was conducted.
RESULTS: 30 TORS procedures were successfully completed (15 benign, 15 malignant) without intraoperative complication or conversion to open surgery. Setup time significantly decreased over the study period. Instrumentation challenges were identified, urging the need for TORS-specific instruments. The study introduced four-arm surgery, showcasing Versius\' unique capabilities, although limitations in distal access were observed.
CONCLUSIONS: TORS is feasible with the Versius Surgical System. The development of TORS-specific instruments would benefit performance and wider adoption of the system. 4-arm surgery is possible however further evaluation is required. Multicentre evaluation (IDEAL stage 2b) is recommended.