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โ† Trials
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Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer

RecruitingNAAges 18 Years - 75 YearsFemaleUniversity of Rome Tor Vergata
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In plain words

What the trial is, and whether it could suit you

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 disch

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
\*\*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
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What it tests

  • AMADeuS Perioperative Pathway
  • Usual Perioperative Care
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Where

1 site
PTV Policlinico Tor Vergata University Hospital
Rome, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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