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

Conditions

• Breast Cancer
• Mastectomy
• Prepectoral Breast Reconstruction
• ERAS Programmes

Interventions

OTHER

AMADeuS Perioperative Pathway

Integrated perioperative care pathway for participants undergoing nipple-sparing or skin-sparing mastectomy with immediate prepectoral implant-based reconstruction. The pathway includes same-day admission, awake monitored anesthesia care without routine airway devices, local anesthesia and interfascial blocks when appropriate, multimodal opioid-sparing analgesia, enhanced recovery measures, same-day discharge when discharge criteria are met, telemedicine follow-up at 7 days, and sustainability-oriented operating room practices including selective opening of instrument sets and waste segregation.

OTHER

Usual Perioperative Care

Standard institutional perioperative care for participants undergoing nipple-sparing or skin-sparing mastectomy with immediate prepectoral implant-based reconstruction. This pathway includes hospital admission according to routine practice, anesthetic management based on clinician judgment, possible use of general anesthesia or airway devices when indicated, standard inpatient postoperative stay, discharge in the following days based on clinical status, routine in-person postoperative follow-up, and standard operating room organization without protocolized sustainability measures.

Sponsors & Collaborators

• University of Rome Tor Vergata

  lead OTHER

Principal Investigators

• Gianluca Vanni, Associate Professor · University of Rome Tor Vergata

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2028-03-01

Completion

2028-04-01

Countries

• Italy

Study Locations