Olson Birk, Cahill Ellen, Imanguli Matin
Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, USA.
Division of Head and Neck Oncologic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.
J Robot Surg. 2023 Apr;17(2):571-576. doi: 10.1007/s11701-022-01449-y. Epub 2022 Aug 16.
The collective experience supporting the safety and efficacy of transoral robotic surgery continues to grow. The surgical robot da Vinci Xi has been used successfully off-label for head and neck surgery, including transoral robotic surgery. We evaluated operative outcomes and efficacy of the da Vinci Xi surgical robot for transoral surgery and compared our experience with the da Vinci Si and published da Vinci Xi experiences in transoral surgery. Nineteen total cases were retrospectively reviewed, six with the Si and thirteen with the Xi. Our experience with the da Vinci Xi showed similar peri- and postoperative outcomes to our Si experience the available da Vinci Xi literature. We advocate for careful patient selection while also considering the surgical team's experience with TORS. Transoral robotic surgery with the da Vinci Xi has specific advantages, and support is accumulating for its use in TORS. However, this indication remains off-label, and we do not anticipate the manufacturer will seek approval for this indication given the ongoing development and regulatory approvals of da Vinci Single Port for similar indications.
支持经口机器人手术安全性和有效性的集体经验不断积累。手术机器人达芬奇Xi已成功用于头颈部手术的非标签用途,包括经口机器人手术。我们评估了达芬奇Xi手术机器人用于经口手术的手术结果和疗效,并将我们的经验与达芬奇Si以及已发表的达芬奇Xi经口手术经验进行了比较。回顾性分析了19例病例,其中6例使用Si,13例使用Xi。我们使用达芬奇Xi的经验显示,围手术期和术后结果与我们使用Si的经验以及现有的达芬奇Xi文献相似。我们主张谨慎选择患者,同时也要考虑手术团队进行经口机器人手术(TORS)的经验。使用达芬奇Xi进行经口机器人手术有其特定优势,支持其用于经口机器人手术的证据也在不断积累。然而,这一适应症仍属非标签使用,鉴于达芬奇单孔机器人在类似适应症方面的持续研发和监管批准,我们预计制造商不会寻求该适应症的批准。