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

NCT ID NCT07510698

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

\*\*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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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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.