Rathat Gauthier, Chaumette Maude, Fontaine Victoria, Rebel Lucie, Pissarra Joana, Duflos Claire, Duraes Martha
Department of gynaecological and breast surgery, CHU Arnaud de Villeneuve, 371 Av. du Doyen Gaston Giraud, 34090 Montpellier, France.
Department of gynaecological and breast surgery, CHU Arnaud de Villeneuve, 371 Av. du Doyen Gaston Giraud, 34090 Montpellier, France.
J Gynecol Obstet Hum Reprod. 2025 Jan;54(1):102862. doi: 10.1016/j.jogoh.2024.102862. Epub 2024 Oct 10.
Current recommendations preconize prophylactic mastectomy for women over 30 with increased risk of breast cancer. Several surgical techniques are available to perform bilateral mastectomy with or without breast reconstruction. Our primary objective was to evaluate the feasibility of the Endoscopic Nipple Sparing Mastectomy (E-NSM) technique, without robotic assistance, using a single axillary incision and with immediate reconstruction using a prepectoral prosthesis in prophylactic indications. The secondary objectives were to evaluate the risks of postoperative complications and the esthetic results.
This is a preliminary report of a prospective single-center interventional clinical study with a final enrolment target of 20 patients. The primary endpoint was the rate of complete surgical procedures per E-NSM. The secondary endpoints were the rate of conversions to conventional surgery, infections, hematomas, skin injury, pain and esthetic results (Breast-Q questionnaire, additional cosmetic procedures).
From April 2019 to June 2022, 10 patients were included for 19 procedures (9 bilateral mastectomies, 1 unilateral). All surgical procedures were complete; no conversion to conventional surgery was required. The rate of complications per procedure requiring revision surgery was 16 % (1 skin necrosis, 1 postoperative hematoma and 1 surgical site infection). No prosthesis was removed. The seroma rate was 5 %. All patients would recommend this technique and were very satisfied or satisfied with the esthetic result. A second cosmetic procedure (lipofilling) was necessary in 50 % of patients.
These preliminary data attest to the feasibility and safety of the E-NSM approach, and should be confirmed on a larger cohort and longer-term follow-up.
NCT03838549.
目前的建议主张对30岁以上乳腺癌风险增加的女性进行预防性乳房切除术。有几种手术技术可用于进行双侧乳房切除术,可选择是否进行乳房重建。我们的主要目标是评估在无机器人辅助的情况下,使用单一腋窝切口并在预防性适应症中使用胸前假体进行即刻重建的内镜保留乳头乳房切除术(E-NSM)技术的可行性。次要目标是评估术后并发症风险和美学效果。
这是一项前瞻性单中心干预性临床研究的初步报告,最终入组目标为20例患者。主要终点是每次E-NSM的完整手术率。次要终点是转为传统手术的比率、感染、血肿、皮肤损伤、疼痛和美学效果(乳房Q问卷、额外的美容手术)。
从2019年4月至2022年6月,10例患者接受了19次手术(9例双侧乳房切除术,1例单侧乳房切除术)。所有手术均完成;无需转为传统手术。需要翻修手术的每次手术并发症发生率为16%(1例皮肤坏死、1例术后血肿和1例手术部位感染)。未移除任何假体。血清肿发生率为5%。所有患者都推荐这项技术,并且对美学效果非常满意或满意。50%的患者需要进行第二次美容手术(脂肪填充)。
这些初步数据证明了E-NSM方法的可行性和安全性,应在更大的队列和更长时间的随访中得到证实。
NCT03838549。