Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorUniversity of Rome Tor Vergata
About this trial
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 close enough to the hospital for safe discharge.
Participants will:
* be assigned by chance to the AMADeuS pathway or to usual hospital care have mastectomy with immediate prepectoral reconstruction report their pain during the first 48 hours after surgery * be checked for medical problems during the first 30 days after surgery complete questionnaires about quality of life, symptoms, and satisfaction with care during follow-up * have follow-up visits either through telemedicine and planned local care support or through standard hospital follow-up, depending on the group they are assigned to
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
AMADeuS Perioperative Pathway
Other interventionIntegrated 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.
Usual Perioperative Care
Other interventionStandard institutional perioperative care for participants undergoing nipple-sparing or skin-sparing mastectomy with immediate prepectoral implant-based reconstruction. This pathway includes hospital admission according to routine practice, anesthetic management based on clinician judgment, possible use of general anesthesia or airway devices when indicated, standard inpatient postoperative stay, discharge in the following days based on clinical status, routine in-person postoperative follow-up, and standard operating room organization without protocolized sustainability measures.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: AMADeuS PathwayExperimental treatment 1 intervention
Group B: Usual Care PathwayActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
0 to 48 hours after surgery2
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.
Time frame
Within 30 days after surgerySecondary outcomes
1
Postoperative pain during movement over 48 hours
Pain during movement will be assessed as the area under the curve (AUC) for Numeric Pain Rating Scale (NPRS, 0-10) pain during mobilization measured at 0, 2, 24, and 48 hours after surgery. Lower values indicate less postoperative pain during movement.
Time frame
0 to 48 hours after surgery2
Maximum postoperative pain over 48 hours
Highest Numeric Pain Rating Scale (NPRS, 0-10) score recorded during the first 48 hours after surgery. Lower values indicate less severe pain.
Time frame
0 to 48 hours after surgery3
Rescue analgesic use over 48 hours
Number of rescue analgesic administrations required during the first 48 hours after surgery.
Time frame
0 to 48 hours after surgery4
Postoperative nausea and vomiting over 48 hours
Occurrence of postoperative nausea and vomiting recorded during the first 48 hours after surgery.
Time frame
0 to 48 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov