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

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

Trial Details

NCT ID
NCT07510698
Phase
NA
Sponsor
University of Rome Tor Vergata
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • AMADeuS Perioperative Pathway
  • Usual Perioperative Care
Locations (sample)
  • Rome, Rome, Italy|41.89193,12.51133

Key Eligibility 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 def…
  • Eligible for prepectoral reconstruction based on clinico-anatomic criteria, including adequate skin flap thickness, no relevant vascular compromise…
  • American Society of Anesthesiologists (ASA) class I to III

For full eligibility, visit ClinicalTrials.gov.

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