A Prospective, Multicenter Randomized Controlled Trial (RCT) of the da Vinci SP ® Surgical System versus Open Surgery in Nipple-Sparing Mastectomy (NSM) Procedures for Patients with Breast Cancer.
Ann Surg OncolJul 16, 2026 (epub)
Katherine Kopkash, Mara Piltin, James Jakub et al.
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In 30 seconds
This multicenter randomized controlled trial compared robotic-assisted nipple-sparing mastectomy (rNSM) using the da Vinci SP® system to open nipple-sparing mastectomy (NSM) in women with early-stage breast cancer. Among 74 patients, rNSM had a longer operative time (141.6 vs 83.9 min) but no conversions to open surgery, and similar positive surgical margin rates (6 patients each).
Key findings
- Operative time was significantly longer for rNSM at 141.6 minutes compared to 83.9 minutes for open NSM.
- Nipple-areolar complex preservation was 100% for rNSM and 98.5% for open NSM at 42 days.
- Serious adverse events occurred in three rNSM patients and eight open NSM patients.
- Higher BREAST-Q scores were reported for rNSM in multiple domains.
Why it matters
The study provides evidence that robotic-assisted nipple-sparing mastectomy is feasible and has a safety profile comparable to traditional open surgery, which may influence surgical decision-making in early-stage breast cancer management.