Condition: Breast Cancer · Mastectomy · Prepectoral Breast Reconstruction · Sponsor: University of Rome Tor Vergata
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 clo…
This description comes directly from the study's public registry record.
Gianluca vanni, Associate Professor · +393395685883 · vanni_gianluca@yahoo.it
Marco Materazzo, MD PhD · +393395685883 · marco.materazzo@ptvonline.it
Always discuss trial participation with your own doctor first.
| PTV Policlinico Tor Vergata University Hospital | Rome, Rome, Italy | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07510698