Evaluation of Safety, Quality of Life, Cost and Environmental Impact of Day Surgery in Mastectomy and Prepectoral Reconstruction - Awake MAstectomy in Day Surgery With Immediate Prepectoral Implant Reconstruction and Muscle Sparing

Breast cancer remains one of the most common indications for mastectomy, despite the increasing use of breast-conserving approaches in selected patients. In current practice, nipple-sparing mastectomy and skin-sparing mastectomy followed by immediate implant-based reconstruction aim to maintain oncologic safety while improving aesthetic, functional, and psychosocial outcomes. Within implant-based reconstruction, the prepectoral approach avoids elevation of the pectoralis major muscle and may reduce muscle-related morbidity, postoperative pain, and animation deformity in appropriately selected participants.

Perioperative breast surgery pathways are also evolving toward higher-value care models based on enhanced recovery after surgery, opioid-sparing anesthesia, day surgery, and structured remote follow-up. Existing evidence supporting same-day discharge after mastectomy with immediate reconstruction suggests that this approach can be feasible and safe in selected patients when perioperative criteria and post-discharge support are standardized. In parallel, healthcare systems are increasingly required to consider resource use and environmental impact in addition to conventional clinical outcomes.

The AMADeuS protocol (Awake MAstectomy in Day surgery with immediate prepectoral implant reconstruction and muscle Sparing) was developed to integrate these elements into a single perioperative pathway for patients undergoing nipple-sparing or skin-sparing mastectomy with immediate prepectoral prosthetic reconstruction. The study is a prospective randomized single-center trial comparing the AMADeuS pathway with the institution's standard perioperative management. Its overall aim is to determine whether this integrated pathway can maintain clinical safety and adequate postoperative pain control while improving recovery, reducing hospital resource use, and lowering the environmental burden of care.

In the experimental arm, the AMADeuS pathway combines outpatient-oriented pre-admission planning, enhanced recovery principles, awake monitored anesthesia care with local anesthesia and interfascial locoregional blocks when appropriate, multimodal opioid-sparing analgesia, same-day discharge when discharge criteria are met, and structured telemedicine-supported follow-up. Preoperative management includes reduced fasting, carbohydrate loading, and risk-adapted thromboprophylaxis. Intraoperative management includes systematic antiemetic prophylaxis, targeted oxygen delivery, and minimization of unnecessary drug and material use according to a "do not open unless needed" approach. The operating room workflow is also organized to reduce waste through modular instrument sets opened only if required, reduced use of disposable devices, monitoring of personnel present in the room, and segregation of waste into predefined categories for environmental assessment. Postoperatively, the pathway promotes early oral intake, early mobilization, short ambulatory observation, same-day discharge when clinically appropriate, telemedicine review at 7 days, and suture removal either in clinic or through local primary care support.

In the control arm, participants undergo the same underlying surgical indication and reconstructive strategy within the hospital's usual care pathway. Standard care includes inpatient admission, perioperative management according to routine anesthetic and surgical practice, postoperative ward stay, and in-person postoperative follow-up. In this arm, anesthesia technique, airway management, instrument preparation, and operating room waste handling are left to standard institutional practice and clinician preference rather than protocolized sustainability measures.