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

The study will be a prospective, multicentre, single-blinded (outcome assessor-blinded), randomised controlled trial conducted within an Irish cancer network using a hub-and-spoke model for robotic surgery delivery. The trial will compare robotic-assisted versus conventional open nipple-sparing mastectomy (NSM) in patients undergoing immediate breast reconstruction. Participants will be stratified by type of reconstruction and randomised in a 1:1 ratio within each stratum. Two reconstruction cohorts will be studied: Implant Reconstruction Cohort Arm A1: Robotic-assisted NSM with immediate implant-based reconstruction Arm A2: Standard open NSM with immediate implant-based reconstruction Autologous Reconstruction (DIEP) Cohort Arm B1: Robotic-assisted NSM with immediate DIEP flap reconstruction Arm B2: Standard open NSM with immediate DIEP flap reconstruction Randomisation will be stratified by recruiting site and reconstruction type. Robotic-assisted NSM procedures will be performed at the designated network hub, while standard open NSM procedures will be undertaken either at the referring site or centrally, depending on reconstructive requirements. All patients eligible for mastectomy and immediate reconstruction will be screened for inclusion. Eligibility for nipple-sparing mastectomy will be determined based on clinical and radiological criteria, including the absence of tumour involvement of the skin or nipple-areolar complex and an adequate tumour-to-nipple distance, in accordance with institutional and national guidelines. Patients not suitable for NSM will not be randomised and will undergo standard-of-care mastectomy outside the trial. Blinding will be applied to outcome assessment. Independent assessors evaluating aesthetic outcomes and analysing patient-reported outcome measures, including Breast-Q, Hopwood Body Image Scale, and Aesthetic Item Scale (AIS), will be blinded to treatment allocation. Due to the nature of the surgical interventions, blinding of patients and surgeons will not be feasible.