Department of Surgical Oncology and Gastrointestinal Surgery, Erasmus MC Cancer Institute, Rotterdam, Zuid-Holland, The Netherlands
Department of Plastic and Reconstructive Surgery, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands.
BMJ Open. 2023 Feb 17;13(2):e066728. doi: 10.1136/bmjopen-2022-066728.
Bilateral prophylactic mastectomy (BPM) in women with a high risk of developing breast cancer has shown to provide the greatest risk reduction. Many surgical guidelines recommend the removal of the pectoral fascia (PF) in mastectomies; however, there is no evidence to support this statement. Reported wound-related complications following mastectomy include seroma, flap necrosis, infection and haematoma. Seroma causes discomfort and may delay the reconstructive procedures. Whether removal or preservation of the PF influences drain volume, seroma formation and other postoperative complications following BPM remains unclear. The aim of this study is to assess the impact of removal versus preservation of the PF on drain policy and seroma after BPM.
This is a double blinded, prospective, randomised controlled pilot study with a within-subject design. The inclusion criteria are women >18 years, presenting in the Academic Breast Cancer Centre Rotterdam, who are opting for BPM. Patients with a history or diagnosis of breast cancer are excluded. According to the sample size calculation based on the difference in total drain volume, a number of 21 eligible patients will be included. Randomisation will occur within the patient, which means PF preservation in one breast and PF removal in the contralateral breast. The primary study endpoint is total drainage volume. Secondary study outcomes include time to drain removal, number of needle aspirations, postoperative complications and length of hospital stay.
The study is approved by the Erasmus Medical Center Review Board (REC 2020-0431). Results will be presented during international conferences and published in a peer-reviewed academic journal.
NCT05391763; clinicaltrials.gov.
双侧预防性乳房切除术（BPM）在罹患乳腺癌风险较高的女性中已被证明能提供最大的风险降低。许多外科手术指南建议在乳房切除术中切除胸大肌筋膜（PF）；然而，目前尚无证据支持这一说法。乳房切除术后报告的与伤口相关的并发症包括血清肿、皮瓣坏死、感染和血肿。血清肿会引起不适，并可能延迟重建手术。BPM 后 PF 的切除或保留是否会影响引流管的体积、血清肿的形成和其他术后并发症仍不清楚。本研究旨在评估 PF 的切除与保留对 BPM 后引流管政策和血清肿的影响。
这是一项双盲、前瞻性、随机对照的初步研究，采用自身对照设计。纳入标准为年龄>18 岁、在鹿特丹学术乳腺癌中心就诊、选择 BPM 的女性。有乳腺癌病史或诊断的患者被排除在外。根据基于总引流管体积差异的样本量计算，将纳入 21 名符合条件的患者。将在患者内部进行随机分组，这意味着一侧乳房保留 PF，另一侧乳房切除 PF。主要研究终点是总引流管体积。次要研究结果包括引流管去除时间、抽吸针数、术后并发症和住院时间。
该研究已获得伊拉斯谟医学中心审查委员会（REC 2020-0431）的批准。结果将在国际会议上展示，并发表在同行评议的学术期刊上。
NCT05391763；clinicaltrials.gov。
