A Prospective, Multicenter Randomized Controlled Trial (RCT) of the da Vinci SP

Document Type

Article

Publication Date

7-16-2026

Publication Title

Annals of surgical oncology : the official journal of the Society of Surgical Oncology

Abstract

BACKGROUND: This prospective randomized trial evaluated the safety and effectiveness of robotic-assisted nipple-sparing mastectomy (rNSM) using the da Vinci Single Port (SP)

PATIENTS AND METHODS: This Food and Drug Administration (FDA) investigational device exemption (IDE)-approved, two-arm, multicenter randomized controlled trial (RCT) randomized eligible women (clinical Tis-T2, N0) 1:1 to rNSM or open NSM with immediate implant-based reconstruction. Operations were performed at 14 US sites by 23 surgeons. Primary endpoints included conversion to open surgery, adverse events at 42 days, and positive surgical margin (PSM) rates. Secondary outcomes included operative time, estimated blood loss, nipple-areolar complex (NAC) and skin flap viability, final pathology, and patient-reported outcomes (BREAST-Q).

RESULTS: Overall, 74 patients completed surgery, totaling 65 rNSM (38 therapeutic, 27 prophylactic) and 66 open NSM (38 therapeutic, 28 prophylactic). Operative time was longer for rNSM (141.6 versus 83.9 min) with no conversions to open surgery. Serious adverse events (SAEs) occurred in three rNSM and eight open NSM patients, with no device-related SAEs reported. NAC preservation at 42 days was 100% for rNSM and 98.5% for open NSM. PSM rates were identical (six patients each). Higher BREAST-Q scores favored rNSM in multiple domains.

CONCLUSIONS: These results demonstrate that da Vinci SP

DOI

10.1245/s10434-026-20201-6

ISSN

1534-4681

PubMed ID

42463607

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