Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer

Summary

The goal of this clinical trial is to learn if the AMADeuS care pathway is as safe as usual hospital care and works as well for pain control in women having mastectomy with immediate prepectoral breast reconstruction. The study will also look at quality of life, satisfaction with care, hospital resource use, and environmental impact. The main questions it aims to answer are: 1. Does the AMADeuS pathway control pain during the first 48 hours after surgery as well as usual hospital care? 2. Is the AMADeuS pathway as safe as usual hospital care during the first 30 days after surgery? 3. Can the AMADeuS pathway improve recovery, reduce hospital stay and hospital visits, and lower the environmental impact of care? Researchers will compare the AMADeuS pathway with usual hospital care. In the AMADeuS pathway, participants will have awake surgery with monitored anesthesia care, same-day discharge when safe, and follow-up that includes telemedicine. In the usual care group, participants will receive the hospital's standard perioperative care, which usually includes admission to the ward and follow-up visits at the hospital. Participants may be women 18 to 75 years old who need nipple-sparing or skin-sparing mastectomy with immediate prepectoral reconstruction for early breast cancer or to lower future breast cancer risk. Participants must be suitable for day surgery and telemedicine follow-up. This includes having home support during the first 24 hours after surgery and living close enough to the hospital for safe discharge. Participants will: * be assigned by chance to the AMADeuS pathway or to usual hospital care have mastectomy with immediate prepectoral reconstruction report their pain during the first 48 hours after surgery * be checked for medical problems during the first 30 days after surgery complete questionnaires about quality of life, symptoms, and satisfaction with care during follow-up * have follow-up visits either through telemedicine and planned local care support or through standard hospital follow-up, depending on the group they are assigned to

Eligibility

\*\*Inclusion Criteria:\*\*

* Biologically female participants aged 18 to 75 years
* Oncologic or prophylactic indication for nipple-sparing mastectomy or skin-sparing mastectomy with immediate prepectoral reconstruction using a definitive implant or tissue expander, including early breast cancer or a high-risk genetic condition such as BRCA
* Eligible for prepectoral reconstruction based on clinico-anatomic criteria, including adequate skin flap thickness, no relevant vascular compromise, body mass index less than 35, and no severe prior chest radiotherapy
* American Society of Anesthesiologists (ASA) class I to III
* Eligible for day surgery, defined by home autonomy, caregiver availability during the first 24 hours after surgery, and distance from the hospital compatible with home management
* Able and willing to complete telemedicine follow-up, including completion of protocol-required patient-reported outcome measures
* Written informed consent provided

\*\*Exclusion Criteria:\*\*

* Chronic opioid use or treatment for pre-existing chronic pain that could interfere with assessment of the primary postoperative pain endpoint
* Contraindications to locoregional anesthesia techniques or to the awake/monitored anesthesia care protocol, including allergy to local anesthetics, coagulation disorders, or inability to cooperate during surgery
* Body mass index 35 or greater, or anatomic conditions contraindicating prepectoral reconstruction
* Previous high-dose chest radiotherapy with significant tissue compromise
* Pregnancy or breastfeeding
* Inability to guarantee planned follow-up or lack of adequate home support
* Psychiatric or cognitive conditions preventing correct completion of patient-reported outcome measures

Conditions5

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