Condition: Breast Cancer · Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
This randomized, open-label study compares endoscopic skin-sparing mastectomy (E-SSM) with conventional mastectomy (CM) in female patients with unilateral invasive breast cancer (T1-4aN0-3M0). The primary objective is to evaluate differences in postoperative wound complications and patient satisfaction, with secondary outcomes including breast appearance and oncological safety. Eligible patients have a breast volume ≤ cup C and no/mild ptosis (grade I-II). A total of 258 participants (129 per group) will be enrolled across multiple centers and randomized by site. This study aims to provide evidence for selecting optimal endoscopic surgical strategies, address the evidence gap for E-SSM without immediate reconstruction, and advance the precision of breast cancer surgery.
This description comes directly from the study's public registry record.
Shicheng Su · +86 13631304227 · sushch@mail.sysu.edu.cn
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| Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Guangzhou, Guangdong, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07548762