Shuck John, Asaad Malke, Liu Jun, Clemens Mark W, Selber Jesse C
From the Department of Plastic Surgery, University of Texas M. D. Anderson Cancer Center.
Plast Reconstr Surg. 2022 Jun 1;149(6):1287-1295. doi: 10.1097/PRS.0000000000009086. Epub 2022 Mar 29.
There are no U.S. Food and Drug Administration (FDA)-approved indications for robotic plastic surgery. This study was designed to demonstrate safety and efficacy of the robotic latissimus dorsi harvest for FDA approval.
This prospective, single-arm study was conducted under an investigational device exemption through the FDA for obtaining 510(k) approval. The primary safety endpoint was adverse events attributable to harvest. Primary efficacy endpoints included muscle viability after harvest and conversion to open technique. Secondary endpoints included postoperative pain and upper extremity function.
Fifteen patients enrolled, with a mean age of 50 ± 10 years and a mean body mass index of 25 ± 4 kg/m2. There were no adverse events, all muscles were viable after harvest, and there were zero conversions to open procedures. Visual analogue scale scores for pain progressively decreased postoperatively and returned to baseline, indicating resolution of postoperative pain. Physical therapy assessment demonstrated recovery of function in all range-of-movement domains by 36 weeks. There was no difference in function of the operated extremity between baseline and 36 weeks' follow-up for Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (p = 0.87); QuickDASH Work Module (p > 0.05); and QuickDASH Sports Module (p > 0.05).
The use of the da Vinci Robotic Surgical System is safe based on zero adverse events attributable to harvest and efficacious based on 100 percent muscle viability after harvest and zero conversions to open technique. There appears to be little to no long-term functional deficit or pain from muscle harvest. Given these results and their own prestudy guidelines, the robotic latissimus dorsi qualifies for 510(k) submission by Intuitive Surgical and approval by the U.S. FDA.
CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.
美国食品药品监督管理局（FDA）尚未批准机器人进行整形手术的适应症。本研究旨在证明机器人背阔肌切取术的安全性和有效性，以获得FDA批准。
本前瞻性单臂研究是在FDA的研究器械豁免下进行的，以获得510（k）批准。主要安全终点是与切取相关的不良事件。主要疗效终点包括切取后肌肉的活力以及转为开放手术的情况。次要终点包括术后疼痛和上肢功能。
15例患者入组，平均年龄50±10岁，平均体重指数25±4kg/m²。未发生不良事件，切取后所有肌肉均存活，且无转为开放手术的情况。术后疼痛的视觉模拟评分逐渐下降并恢复至基线水平，表明术后疼痛得到缓解。物理治疗评估显示，在36周时所有活动范围领域的功能均恢复。在基线和36周随访时，手臂、肩部和手部快速残疾问卷（QuickDASH）（p = 0.87）、QuickDASH工作模块（p>0.05）和QuickDASH运动模块（p>0.05）评估的手术肢体功能无差异。
基于切取相关的不良事件为零，达芬奇机器人手术系统的使用是安全的；基于切取后肌肉100%存活且无转为开放手术的情况，该系统是有效的。肌肉切取似乎几乎没有长期功能缺陷或疼痛。鉴于这些结果以及他们自己的研究前指南，机器人背阔肌切取术有资格由直观外科公司提交510（k）申请并获得美国FDA批准。
临床问题/证据水平：治疗性，IV级。
