Robotic-assisted versus conventional nipple-sparing mastectomy with immediate implant-based breast reconstruction: a GRADE-assessed systematic review and meta-analysis of prospective studies

Clinical Snapshot

Key Findings

• P Value: Statistically significant (CI does not cross zero); exact p-value not reported in abstract

• Effect Size: Mean difference (MD) +64.01 minutes (robotic longer than conventional)

• Primary Outcome: Total operative time: robotic NSM was associated with significantly longer operative time than conventional NSM

• Nnt Or Sensitivity: Major complications: RR 0.63 (95% CI 0.27–1.47), non-significant. NAC ischemia/necrosis: RR 0.56 (95% CI 0.28–1.11), non-significant. Length of hospital stay: MD +0.22 days (95% CI −0.26 to 0.70), non-significant. No NNT calculable given non-significant complication outcomes and wide CIs. GRADE certainty: LOW for all outcomes.

• Confidence Interval: 95% CI: 8.54 to 119.47 minutes

Clinical Application

Robotic NSM requires significant capital investment in robotic platforms (da Vinci system), specialised surgical training, and institutional infrastructure. The demonstrated operative time increase of approximately 64 minutes per case has direct implications for theatre scheduling, anaesthetic resource use, and per-case costs. Feasibility is currently limited to high-volume tertiary centres with established robotic surgery programmes and dedicated learning curve support. In Australia, robotic surgery platforms are available at select public and private tertiary centres, predominantly in major metropolitan areas. The TGA has approved robotic surgical systems for use in Australia, but robotic NSM is not yet a standard-of-care procedure and is not specifically addressed in current RACGP or Cancer Australia breast cancer management guidelines. There is no PBS item number specifically for robotic mastectomy, and the additional costs associated with robotic platforms are typically borne by institutions or passed to private patients. Australian breast surgeons considering adoption should note that the current evidence base — rated LOW certainty by GRADE — does not support routine implementation outside of prospective registry or trial settings. The BreastSurgANZ (Breast Surgeons of Australia and New Zealand) position on robotic breast surgery has not been formally updated to reflect this emerging technique, and engagement with this body regarding credentialling and outcome monitoring would be appropriate before broader adoption. Women undergoing nipple-sparing mastectomy with immediate implant-based reconstruction at experienced robotic surgery centres, particularly those prioritising scar concealment and minimally invasive access. Most applicable to patients with early-stage breast cancer or BRCA-related prophylactic indications where NSM is oncologically appropriate.

Abstract

BACKGROUND: Robotic nipple-sparing mastectomy with immediate implant-based reconstruction is increasingly adopted to improve cosmetic outcomes and patient experience; however, its comparative perioperative value against conventional or open nipple-sparing mastectomy remains uncertain when restricted to prospective evidence. METHODS: We performed a PRISMA-aligned systematic review and random-effects meta-analysis of prospective comparative studies and randomized trials comparing robotic versus conventional or open nipple-sparing mastectomy with immediate implant-based reconstruction. The primary outcome was the total operative time, and the secondary outcomes were major complications, nipple-areolar complex ischemia or necrosis, and length of hospital stay. The risk of bias was assessed using RoB 2 for randomized data and ROBINS-I for nonrandomized data. Leave-one-out sensitivity analyses were conducted for outcomes with substantial heterogeneity, and the certainty of the evidence was graded using GRADE. RESULTS: Three prospective studies were included. Robotic surgery was associated with a significantly longer total operative time (mean difference 64.01 min, 95% confidence interval 8.54-119.47). Major complications did not differ between the approaches (risk ratio 0.63, 95% confidence interval 0.27-1.47), nor did nipple areolar complex ischemia or necrosis (risk ratio 0.56, 95% confidence interval 0.28-1.11) or length of hospital stay (mean difference 0.22 days, 95% confidence interval - 0.26 to 0.70). Heterogeneity was high for operative time and moderate to substantial for length of stay. The certainty of the evidence was low overall, driven by imprecision, heterogeneity, and limitations of the non-randomized design. CONCLUSIONS: Robotic nipple-sparing mastectomy is associated with a longer operative time than conventional or open approaches. No statistically significant differences were observed in major complications or nipple-areolar complex viability; however, the current prospective evidence base is limited, heterogeneous, and imprecise, and clinically important differences cannot be excluded. In experienced centers, robotic nipple-sparing mastectomy may be considered for carefully selected patients who prioritize scar concealment and minimally invasive access; however, its broader role in routine practice remains uncertain pending stronger prospective data on safety, patient-reported outcomes, and resource use.

References

1. 1.Mirza, W., Iqbal, H., Khan, M. E., Khan, A., & Khan, H. M. (2026). Robotic-assisted versus conventional nipple-sparing mastectomy with immediate implant-based breast reconstruction: a GRADE-assessed systematic review and meta-analysis of prospective studies. World Journal of Surgical Oncology. https://doi.org/10.1007/s11701-024-01913-x