Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2025
Nipple-sparing mastectomy (NSM) preserves the nipple-areolar complex (NAC) and can improve cosmetic outcomes, body image and patient satisfaction. It is increasingly used for risk-reducing surgery, ductal carcinoma in situ (DCIS), and early breast cancer where the NAC is not involved. Studies indicate that NSM is oncologically safe in appropriately selected patients, although careful surgical and pathological assessment is required to minimise the risk of residual disease. Robotic-assisted NSM has emerged as a minimally invasive alternative offering enhanced visualisation, greater precision, and reduced surgeon fatigue. The Da Vinci single-port (SP) system enables NSM through a single axillary incision, potentially reducing postoperative pain and visible scarring while maintaining oncologic safety. Early series, including those by Toesca, Farr and Sarfati, demonstrate feasibility and suggest comparable outcomes to conventional NSM with possible aesthetic advantages. Despite broader adoption of NSM-both standard and robotic-there is limited high-quality evidence evaluating patient-reported outcomes (PROs). Tools such as the Breast-Q, Hopwood Body Image Scale, and Aesthetic Item Scale (AIS) are validated for assessing satisfaction, psychological well-being and aesthetic outcomes, yet prospective randomised data comparing SP robotic NSM, standard NSM and skin-sparing mastectomy (SSM) remain scarce. Skin-sparing mastectomy (SSM), which removes the NAC while preserving the skin envelope, is an established oncologic technique and provides an important comparator to determine whether NAC preservation yields measurable benefits in PROs. This trial evaluates these surgical approaches exclusively in patients undergoing autologous DIEP flap reconstruction, which provides superior long-term satisfaction and physical well-being compared with implant-based methods. Restricting reconstruction to DIEP flaps reduces heterogeneity and allows the trial to isolate differences attributable to the mastectomy technique itself. This randomised controlled trial will compare SP robotic NSM, standard NSM and SSM using validated PRO measures at multiple postoperative time points. Findings will help determine the relative value of robotic technology and NAC preservation in the context of autologous reconstruction, informing surgical decision-making and future service development.
Epistemonikos ID: 2e7256ae8e39cecddfe2440e743baef4a9bb8b03
First added on: Nov 18, 2025