Mitchell Sunny D, Willey Shawna C, Beitsch Peter, Feldman Sheldon
3241 Suite A, Main St., Stratford, CT, USA.
MedStar Georgetown University Hospital, Washington, DC, USA.
Gland Surg. 2018 Jun;7(3):247-257. doi: 10.21037/gs.2017.09.10.
The American Society of Breast Surgeons (ASBrS) Nipple Sparing Mastectomy Registry (NSMR) is a prospective, non-randomized, IRB approved, multi-institutional registry. The purpose of this Registry is to provide a large, prospective, non-randomized database of patient characteristics, tumor characteristics, surgical technique, and outcome (both aesthetic and oncologic) of the nipple sparing mastectomy (NSM).
Data is entered into the ASBrS NSMR, housed within the Mastery of Surgery Program, after patients consent to participation. Each investigator routinely offers NSM in their practice has obtained IRB approval and completed forms of agreement to participate in the ASBrS NSMR.
This data set represents a total of 1,935 NSMs performed on 1,170 patients by 98 investigators from 70 institutions/sites. Of the 1,935 NSMs: 833 were performed for an indication of cancer [594 invasive carcinoma and 239 for ductal carcinoma in situ (DCIS)] and 1,102 were prophylactic. Of the 1,170 total patients, 352 underwent a unilateral and 818 underwent a bilateral NSM. Recurrence at a mean follow-up of 31 months/median follow-up of 27 months, with a range of 9.7 to 58.3 months since surgery was 1.4% with no recurrences at the nipple or nipple areola complex (NAC). Cancer occurrence (0.3%) also did not involve the nipple/NAC. Overall patient satisfaction of excellent/good: 94.9% and overall cosmesis (surgeon rated) of excellent/good was 96.4%. Overall infection rates included flap infection of 4.4%, NAC complication rate of 4.5% (defined as necrosis/other or ischemia/epidermolysis requiring surgery), and a 10% rate of NAC epidermolysis with full recovery.
NSMs were performed on breasts with a variety of sizes and degrees of ptosis, via multiple incisions, dissection and reconstruction techniques with low complication rates and high patient satisfaction and surgeon rated cosmesis.
美国乳腺外科医师协会(ASBrS)保乳乳头乳房切除术登记处(NSMR)是一个前瞻性、非随机、经机构审查委员会(IRB)批准的多机构登记处。该登记处的目的是提供一个关于保乳乳头乳房切除术(NSM)患者特征、肿瘤特征、手术技术及结果(美学和肿瘤学方面)的大型前瞻性非随机数据库。
在患者同意参与后,数据被录入ASBrS NSMR,该登记处设在手术精通项目内。每位在其临床实践中常规开展NSM的研究者均已获得IRB批准并填写了参与ASBrS NSMR的协议表格。
该数据集代表了来自70个机构/地点的98位研究者对1170例患者实施的总共1935例NSM。在这1935例NSM中:833例因癌症指征实施手术[594例浸润性癌和239例导管原位癌(DCIS)],1102例为预防性手术。在总共1170例患者中,352例接受了单侧NSM,818例接受了双侧NSM。平均随访31个月/中位随访27个月(自手术起9.7至58.3个月)时的复发率为1.4%,乳头或乳头乳晕复合体(NAC)无复发。癌症发生率(0.3%)也未累及乳头/NAC。患者总体满意度为优秀/良好的比例为94.9%,外科医生评定的总体美容效果为优秀/良好的比例为96.4%。总体感染率包括皮瓣感染率为4.4%,NAC并发症发生率为4.5%(定义为坏死/其他情况或缺血/表皮松解需要手术治疗),NAC表皮松解率为10%,但均完全恢复。
通过多种切口、解剖和重建技术,对各种大小和不同程度下垂的乳房实施NSM,并发症发生率低,患者满意度高,外科医生评定的美容效果良好。