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Safety and Feasibility of Single-Port Robotic-Assisted Nipple-Sparing Mastectomy
JAMA Surgery ( IF 16.9 ) Pub Date : 2024-01-17 , DOI: 10.1001/jamasurg.2023.6999
Deborah E. Farr 1 , Nicholas T. Haddock 2 , Juan Tellez 1 , Imad Radi 1 , Rodrigo Alterio 1 , Brendan Sayers 1 , Herbert Zeh 1
Affiliation  

ImportanceRobotic-assisted nipple-sparing mastectomies with multiport robots have been described in the US since 2015; however, significant hurdles to multiport robotic surgery exist in breast surgery.ObjectiveTo demonstrate that the single-port da Vinci SP (Intuitive Surgical) robotic system is feasible in patients undergoing robotic nipple-sparing mastectomy (rNSM).Design, Setting, and ParticipantsAn initial case series of 20 patients at a large university hospital underwent bilateral single-port robotic nipple-sparing mastectomies (SPrNSM) with tissue expander reconstruction from February 1, 2020, through January 4, 2023. Participants included women who met surgical criteria for nipple-sparing mastectomies, per standard of care.InterventionSurgery using a single-port robot and the surgical technique of the authors.Main Outcomes and MeasuresAge, indication, body mass index, breast size, operative time, conversion to open surgery, systemic complications, postoperative skin necrosis, and reported skin and nipple areolar complex (NAC) sensation.ResultsTwenty women aged 29 to 63 years (median, 40 years) underwent bilateral SPrNSM. Eleven patients completed prophylactic surgery due to a high risk for breast cancer (more than 20% lifetime risk) and 9 patients had breast cancer. Breast size ranged from A through D cup with median B cup and a body mass index range of 19.7 through 27.8 (median 24.4). The total duration of the procedure from incision to skin closure for both sides ranged from 205 minutes to 351 minutes (median, 277). The median robotic time for bilateral SPrNSM was 116 minutes and varied by cup size (A cup, 95 minutes; B cup, 140 minutes; C cup, 118 minutes; D cup, 114 minutes) with no inflection point in learning curve. No cases were converted to open and no immediate complications, such as hematoma, positive margins, or recurrence, were seen. In the first 10 patients prior to routine sensation testing, 20 resected breasts had measurable NAC sensation at a range from 4 to 36 months post–index resection (65%). In the second 10 patients of the cohort, measurable NAC was preserved in 13 of 20 resected breasts 2 weeks following the index operation (65%).Conclusion and RelevanceIn this case series, SPrNSM with immediate reconstruction was feasible and performed safely by an experienced breast surgeon with limited previous robotic training. Further studies confirming the preliminary data demonstrating improved NAC and skin sensation following SPrNSM are warranted.Trial RegistrationClinicalTrials.gov Identifier: NCT05245812

中文翻译:

单孔机器人辅助保留乳头乳房切除术的安全性和可行性

自 2015 年起,美国就描述了使用多端口机器人进行机器人辅助的保留乳头的乳房切除术;然而,乳腺手术中多端口机器人手术存在重大障碍。目的证明单端口达芬奇 SP(直观手术)机器人系统在接受机器人乳头保留乳房切除术 (rNSM) 的患者中是可行的。设计、设置和参与者2020 年 2 月 1 日至 2023 年 1 月 4 日期间,一所大型大学医院的 20 名患者接受了双侧单孔机器人保留乳头乳房切除术 (SPrNSM) 和组织扩张器重建。参与者包括符合乳头保留手术标准的女性使用单端口机器人和作者的手术技术进行乳房切除术。主要结果和测量年龄、适应症、体重指数、乳房大小、手术时间、转换为开放手术、全身并发症、术后皮肤坏死,并报告皮肤和乳头乳晕复合体 (NAC) 感觉。结果 20 名年龄 29 至 63 岁(中位数 40 岁)的女性接受了双侧 SPrNSM。11 名患者因乳腺癌风险较高(终生风险超过 20%)而完成了预防性手术,其中 9 名患者患有乳腺癌。乳房尺寸范围为 A 罩杯至 D 罩杯,中位罩杯为 B 罩杯,体重指数范围为 19.7 至 27.8(中位值 24.4)。从切口到两侧皮肤闭合的手术总持续时间为 205 分钟至 351 分钟(中位数为 277 分钟)。双侧 SPrNSM 的中位机器人时间为 116 分钟,并因罩杯大小而异(A 罩杯,95 分钟;B 罩杯,140 分钟;C 罩杯,118 分钟;D 罩杯,114 分钟),学习曲线没有拐点。没有病例转为开放手术,也没有发现直接并发症,如血肿、切缘阳性或复发。在常规感觉测试前的前 10 名患者中,20 名切除的乳房在切除后 4 至 36 个月内具有可测量的 NAC 感觉 (65%)。在该队列的后 10 名患者中,在索引手术后 2 周,20 个切除的乳房中有 13 个保留了可测量的 NAC(65%)。结论和相关性在该病例系列中,立即重建的 SPrNSM 是可行的,并且由经验丰富的乳房安全地进行之前接受过有限机器人培训的外科医生。进一步的研究证实了初步数据表明 SPrNSM 后 NAC 和皮肤感觉得到改善。试验注册ClinicalTrials.gov 标识符:NCT05245812
更新日期:2024-01-17
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