Robotic versus conventional nipple-sparing mastectomy in early breast cancer: a systematic review and meta-analysis

This study aimed to systematically compare robot-assisted nipple-sparing mastectomy (R-NSM) with conventional nipple-sparing mastectomy (C-NSM) in terms of perioperative safety and oncological outcomes through a meta-analysis.

A comprehensive literature search was conducted in PubMed/MEDLINE, Web of Science Core Collection, Embase, and the Cochrane Central Register of Controlled Trials from database inception to February 27, 2026. Controlled studies comparing robotic nipple-sparing mastectomy (R-NSM) and conventional nipple-sparing mastectomy (C-NSM) in women with early-stage breast cancer (stage 0-II, including a small proportion of risk-reducing mastectomy cases) were included. Study selection and data extraction were independently performed by two reviewers, with discrepancies resolved by consensus. Statistical analyses were conducted using Review Manager (RevMan) version 5.4. The primary outcomes were overall postoperative complications, major complications (Clavien-Dindo grade ≥ III), positive surgical margin, and local recurrence. Secondary outcomes included operative time, estimated intraoperative blood loss, length of hospital stay, reoperation rate, and individual postoperative complications (including nipple-areolar complex necrosis, skin-flap necrosis, surgical-site infection, hematoma, seroma, delayed wound healing, and implant loss). Perioperative mortality was not reported in the included studies.

A total of 12 studies involving 2,312 patients (1 RCT and 11 non-randomized studies) were included in the quantitative synthesis. The reported follow-up duration across included studies ranged from 3 to approximately 51 months, with most studies reporting a median or mean follow-up of around 18-30 months. Compared with C-NSM, R-NSM was associated with a lower incidence of overall postoperative complications (RR = 0.82, 95% CI: 0.68-0.99, P = 0.04) and major complications defined as Clavien-Dindo grade ≥ III (RR = 0.44, 95% CI: 0.22-0.86, P = 0.02). R-NSM was also associated with a reduced risk of delayed wound healing (RR = 0.51, 95% CI: 0.26-0.98, P = 0.04). However, no statistically significant differences were observed between the two approaches with respect to nipple-areolar complex necrosis, skin flap necrosis, postoperative infection, hematoma, seroma, implant loss, reoperation rate, positive surgical margin, or local recurrence. R-NSM was associated with longer operative time and a modest reduction in intraoperative blood loss. However, TSA suggested that the cumulative evidence remains insufficient.

Current evidence suggests that, under strict patient selection, R-NSM does not appear to compromise short-term perioperative safety or oncological outcomes when compared with the conventional approach. Although a reduction in composite postoperative complications was observed, no significant differences were identified in most individual major complications, and operative time remains longer. Given the predominance of retrospective studies, limited information size, and relatively short follow-up, further high-quality prospective research is required to more definitively establish the role of R-NSM in clinical practice.