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

NCT ID NCT07510698

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.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • PTV Policlinico Tor Vergata University Hospital

    RECRUITING

    Rome, Rome, 00133, Italy

    Contact Phone: •••-•••-•••• Email: •••••@•••••

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.

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.