Same-day awake mastectomy with immediate prepectoral implant reconstruction
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
This project tests whether the AMADeuS care pathway—awake same-day mastectomy with prepectoral implant reconstruction, opioid-sparing anesthesia, and telemedicine follow-up—controls pain and is as safe as usual hospital care for women having mastectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | University of Rome Tor Vergata Academic / other |
| Locations | 1 site (Rome, Rome) |
| Trial ID | NCT07510698 on ClinicalTrials.gov |
What this trial studies
This interventional comparison follows women undergoing nipple- or skin-sparing mastectomy with immediate prepectoral implant or tissue expander reconstruction who receive either the AMADeuS perioperative pathway or usual hospital care. The AMADeuS pathway combines awake surgery with monitored anesthesia care, enhanced recovery (opioid-sparing) protocols, same-day discharge when safe, and structured telemedicine follow-up. Outcomes include pain control in the first 48 hours, safety over 30 days, patient-reported quality of life and satisfaction, hospital resource use, and environmental impact. Researchers will compare these outcomes between the two care pathways to see if the AMADeuS approach can maintain safety and pain control while reducing resource use and environmental footprint.
Who should consider this trial
Good fit: Biologically female patients aged 18–75 having nipple- or skin-sparing mastectomy with planned immediate prepectoral implant or tissue expander reconstruction, with BMI <35, ASA class I–III, adequate skin flap and no severe prior chest radiotherapy, and who have home autonomy, a caregiver for 24 hours, and distance from hospital compatible with day-surgery discharge are ideal candidates.
Not a fit: Patients who need more complex reconstruction, have inadequate skin flap vascularity, BMI ≥35, severe prior chest radiotherapy, ASA IV comorbidity, lack home support or cannot complete telemedicine follow-up are unlikely to benefit from the same-day awake pathway.
Why it matters
Potential benefit: If successful, the AMADeuS pathway could allow eligible women to have awake same-day mastectomy with immediate prepectoral reconstruction while maintaining pain control and safety, reducing hospital stays and resource use.
How similar studies have performed: Existing studies suggest same-day mastectomy with immediate reconstruction can be feasible and safe in selected patients, but combining awake monitored anesthesia care with a standardized ERAS day-surgery pathway and environmental outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
\*\*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
Where this trial is running
Rome, Rome
- PTV Policlinico Tor Vergata University Hospital — Rome, Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Gianluca Vanni, Associate Professor — University of Rome Tor Vergata
- Study coordinator: Gianluca vanni, Associate Professor
- Email: vanni_gianluca@yahoo.it
- Phone: +393395685883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.