Service de Chirurgie Plastique et Reconstructrice, Gustave Roussy, Villejuif, France.
Service de Biostatistique et d'Epidémiologie, Gustave Roussy, Villejuif, France.
Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.
Robotic nipple-sparing mastectomy (RNSM) could be a significant advancement in the treatment of breast cancers and prophylaxis because the mastectomy is performed without leaving any scar on the breast. The aim of this study was to assess the feasibility and the safety of RNSM with immediate prosthetic breast reconstruction (IPBR).
In this prospective study, RNSM with IPBR was offered to patients with breast cup size A, B or C and ptosis grade ≤ 2. In case of oncologic surgery, RNSM was proposed only if the tumor was located more than 2 cm away from the nipple-areola complex (NAC) and if postoperative radiation was not indicated. In case of prophylactic surgery, RNSM was proposed only if a high-risk genetic mutation had been identified. The primary endpoint was the rate of skin or NAC necrosis. The rate of conversion to open technique, the duration of the procedure, and postoperative complications were also analyzed.
Sixty-three RNSM with IPBR were performed in 33 patients. There were no cases of mastectomy skin flap or NAC necrosis. We had to convert to an open technique in one case (1.6%). Three infections occurred (4.8%), one leading to implant loss (1.6%). No other major complications were observed.
Preliminary data attest to the feasibility, the reproducibility, and the safety of this approach. However, long-term data are needed to confirm the oncological safety and the esthetic stability of the result. Trial registration identifier NCT02673268.
机器人保留乳头的乳房切除术 (RNSM) 可能是治疗乳腺癌和预防的重大进展，因为乳房切除术不会在乳房上留下任何疤痕。本研究的目的是评估 RNSM 联合即刻假体乳房重建 (IPBR) 的可行性和安全性。
在这项前瞻性研究中，为乳房罩杯尺寸为 A、B 或 C 且下垂程度≤2 级的患者提供 RNSM 联合 IPBR。如果是肿瘤手术，只有当肿瘤距离乳晕复合体 (NAC) 超过 2 厘米且不建议术后放疗时，才建议进行 RNSM。如果是预防性手术，只有在发现高危基因突变的情况下，才建议进行 RNSM。主要终点是皮肤或 NAC 坏死的发生率。还分析了转为开放技术的比率、手术持续时间和术后并发症。
在 33 名患者中进行了 63 例 RNSM 联合 IPBR。没有乳房切除术皮瓣或 NAC 坏死的病例。我们有 1 例（1.6%）需要转为开放技术。发生了 3 例感染（4.8%），其中 1 例导致植入物丢失（1.6%）。未观察到其他严重并发症。
初步数据证明了这种方法的可行性、可重复性和安全性。然而，需要长期数据来确认其在肿瘤学安全性和结果的美学稳定性方面的效果。试验注册号 NCT02673268。
