Awake mastectomy and go home same day? new trial tests safety and pain control

NCT ID NCT07510698

Recruiting now Symptom relief Sponsor: University of Rome Tor Vergata Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a new care pathway called AMADeuS, which includes awake surgery, same-day discharge, and telemedicine follow-up, is as safe and effective as standard hospital care for women having mastectomy with immediate breast reconstruction. One hundred women aged 18 to 75 with early breast cancer or high genetic risk will be randomly assigned to either the AMADeuS pathway or usual care. The main goals are to compare pain control over 48 hours and major safety events within 30 days after surgery.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: AMADeuS perioperative care pathway (awake surgery, same-day discharge, telemedicine follow-up)
What this could lead to: If successful, this could make mastectomy with reconstruction a same-day procedure, reducing hospital stays and costs while maintaining safety and pain control.
What could go wrong: This is a small, early-phase trial (100 participants) comparing two care pathways, not a new drug or cure. The results may not apply to all patients, and same-day discharge carries risks if complications arise at home.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for BREAST CANCER are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST CANCER ERAS PROGRAMMES MASTECTOMY PREPECTORAL BREAST RECONSTRUCTION

Contacts and locations

Locations

PTV Policlinico Tor Vergata University Hospital
RECRUITING

Rome, Rome, 00133, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.