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单孔机器人辅助保乳乳头切除术的安全性和可行性。

Safety and Feasibility of Single-Port Robotic-Assisted Nipple-Sparing Mastectomy.

机构信息

Department of Surgery, Division of Surgical Oncology, University of Texas Southwestern Medical Center, Dallas, Texas.

Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, Texas.

出版信息

JAMA Surg. 2024 Mar 1;159(3):269-276. doi: 10.1001/jamasurg.2023.6999.

Abstract

IMPORTANCE

Robotic-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.

OBJECTIVE

To 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 PARTICIPANTS: An 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.

INTERVENTION

Surgery using a single-port robot and the surgical technique of the authors.

MAIN OUTCOMES AND MEASURES

Age, 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.

RESULTS

Twenty 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 RELEVANCE

In 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 REGISTRATION

ClinicalTrials.gov Identifier: NCT05245812.

摘要

重要性

自 2015 年以来,美国已经描述了使用多端口机器人进行机器人辅助保留乳头的乳房切除术;然而,在乳房手术中,多端口机器人手术仍然存在重大障碍。

目的

证明单端口达芬奇 SP(直觉外科)机器人系统在接受机器人保留乳头乳房切除术(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,在一家大型大学医院,根据标准护理,对符合保留乳头乳房切除术手术标准的 20 名患者进行了双侧单端口机器人保留乳头乳房切除术(SPrNSM)和组织扩张器重建。参与者包括接受手术治疗的女性接受保留乳头乳房切除术。

干预措施

使用单端口机器人进行手术,并采用作者的手术技术。

主要结果和措施

年龄、指征、体重指数、乳房大小、手术时间、转为开放手术、全身并发症、术后皮肤坏死以及报告的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高(超过 20%的终身风险)接受了预防性手术,9 名患者患有乳腺癌。乳房大小从 A 罩杯到 D 罩杯不等,中位数为 B 罩杯,体重指数范围为 19.7 至 27.8(中位数为 24.4)。两侧切口至皮肤闭合的总手术时间为 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,且因罩杯大小而异(A 罩杯为 95 分钟;B 罩杯为 140 分钟;C 罩杯为 118 分钟;D 罩杯为 114 分钟),学习曲线没有拐点。没有病例转为开放性,也没有立即出现血肿、阳性边缘或复发等并发症。在常规感觉测试前的前 10 名患者中,20 个切除乳房在索引切除后 4 至 36 个月(中位数 65%)的范围内具有可测量的 NAC 感觉。在队列中的后 10 名患者中,在索引手术 2 周后,20 个切除乳房中有 13 个保留了可测量的 NAC(65%)。

结论和相关性

在本病例系列中,由经验丰富的乳房外科医生进行的具有即时重建的 SPrNSM 是可行的,并且安全进行,该外科医生之前接受的机器人培训有限。需要进一步的研究来证实初步数据,即 SPrNSM 后可改善 NAC 和皮肤感觉。

试验注册

ClinicalTrials.gov 标识符:NCT05245812。

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