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Conditions

Keywords

AmadeusBreast cancerBugsmastectomynipple sparing mastectomyskin sparing mastectomyimmediate breast reconstructionprepectoral breast reconstructionCarbon footprintERASSustainable surgeryPatient-reported outcomesPostoperative painTelemedicineSame-day dischargeDay surgeryAwake breast surgeryMonitored anesthesia care

Outcome Measures

Primary Outcomes (2)

Postoperative pain at rest over 48 hours
Pain control will be assessed as the area under the curve (AUC) for Numeric Pain Rating Scale (NPRS, 0-10) pain at rest measured at 0, 2, 24, and 48 hours after surgery. Lower values indicate less postoperative pain. The primary analysis is based on non-inferiority of the AMADeuS pathway versus usual care.
0 to 48 hours after surgery
Major Postoperative Safety Composite at 30 days
Composite rate of major postoperative safety events within 30 days, including Clavien-Dindo grade III or higher complications, unplanned reoperation, unplanned hospital readmission, or procedure-related emergency department access.
Within 30 days after surgery

Secondary Outcomes (20)

Study Arms (2)

AMADeuS Pathway

EXPERIMENTAL

Participants assigned to this arm undergo nipple-sparing or skin-sparing mastectomy with immediate prepectoral implant-based reconstruction within the AMADeuS perioperative pathway. This pathway includes awake monitored anesthesia care with local anesthesia and interfascial locoregional blocks when appropriate, multimodal opioid-sparing analgesia, enhanced recovery measures, same-day discharge when discharge criteria are met, telemedicine-supported follow-up, and sustainability-oriented operating room practices.

Other: AMADeuS Perioperative Pathway

Usual Care Pathway

ACTIVE COMPARATOR

Participants assigned to this arm undergo nipple-sparing or skin-sparing mastectomy with immediate prepectoral implant-based reconstruction within the institution's standard perioperative care pathway. Usual care includes inpatient admission, perioperative anesthetic and surgical management according to routine clinical practice, postoperative ward stay, discharge in the following days as clinically indicated, and standard in-person hospital follow-up.

Other: Usual Perioperative Care

Interventions

AMADeuS Perioperative PathwayOther

Integrated perioperative care pathway for participants undergoing nipple-sparing or skin-sparing mastectomy with immediate prepectoral implant-based reconstruction. The pathway includes same-day admission, awake monitored anesthesia care without routine airway devices, local anesthesia and interfascial blocks when appropriate, multimodal opioid-sparing analgesia, enhanced recovery measures, same-day discharge when discharge criteria are met, telemedicine follow-up at 7 days, and sustainability-oriented operating room practices including selective opening of instrument sets and waste segregation.

AMADeuS Pathway

Usual Perioperative CareOther

Eligibility Criteria

Age18 Years - 75 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

MeSH Terms

Conditions

Breast NeoplasmsPain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

OUTCOMES ASSESSOR

Masking Details

This is an open-label trial for participants and treating clinicians because the study compares 2 different perioperative care pathways. An independent blinded outcome assessor will review prespecified postoperative clinical outcomes, including 30-day complications, whenever feasible.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Randomized, parallel-assignment, single-center trial comparing two perioperative care pathways in a 1:1 allocation ratio. Participants undergoing nipple-sparing or skin-sparing mastectomy with immediate prepectoral implant-based reconstruction are assigned to either the AMADeuS pathway or the institution's usual care pathway. The experimental model evaluates an integrated awake/day-surgery strategy based on monitored anesthesia care, multimodal opioid-sparing analgesia, same-day discharge when criteria are met, telemedicine-supported follow-up, and sustainability-oriented operating room practices. The control model reflects standard inpatient perioperative management and routine in-person follow-up. The intervention model is pragmatic in that both groups undergo the same underlying oncologic and reconstructive procedure, while the randomized comparison focuses on the perioperative pathway, postoperative management, and organizational model of care.

Sponsor Type

OTHER

Responsible Party

PRINCIPAL INVESTIGATOR

PI Title

Associate Professor

Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (20)

Study Arms (2)

AMADeuS Pathway

Usual Care Pathway

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (20)

Study Arms (2)

AMADeuS Pathway

Usual Care Pathway

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations