An interventional study of AMADeuS Perioperative Pathway and Usual Perioperative Care in Breast Cancer, Mastectomy and Prepectoral Breast Reconstruction, sponsored by University of Rome Tor Vergata. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by University of Rome Tor Vergata · Not applicable, Interventional, and Treatment
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:
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:
Breast cancer remains one of the most common indications for mastectomy, despite the increasing use of breast-conserving approaches in selected patients. In current practice, nipple-sparing mastectomy and skin-sparing mastectomy followed by immediate implant-based reconstruction aim to maintain oncologic safety while improving aesthetic, functional, and psychosocial outcomes. Within implant-based reconstruction, the prepectoral approach avoids elevation of the pectoralis major muscle and may reduce muscle-related morbidity, postoperative pain, and animation deformity in appropriately selected participants.
Perioperative breast surgery pathways are also evolving toward higher-value care models based on enhanced recovery after surgery, opioid-sparing anesthesia, day surgery, and structured remote follow-up. Existing evidence supporting same-day discharge after mastectomy with immediate reconstruction suggests that this approach can be feasible and safe in selected patients when perioperative criteria and post-discharge support are standardized. In parallel, healthcare systems are increasingly required to consider resource use and environmental impact in addition to conventional clinical outcomes.
The AMADeuS protocol (Awake MAstectomy in Day surgery with immediate prepectoral implant reconstruction and muscle Sparing) was developed to integrate these elements into a single perioperative pathway for patients undergoing nipple-sparing or skin-sparing mastectomy with immediate prepectoral prosthetic reconstruction. The study is a prospective randomized single-center trial comparing the AMADeuS pathway with the institution's standard perioperative management. Its overall aim is to determine whether this integrated pathway can maintain clinical safety and adequate postoperative pain control while improving recovery, reducing hospital resource use, and lowering the environmental burden of care.
In the experimental arm, the AMADeuS pathway combines outpatient-oriented pre-admission planning, enhanced recovery principles, awake monitored anesthesia care with local anesthesia and interfascial locoregional blocks when appropriate, multimodal opioid-sparing analgesia, same-day discharge when discharge criteria are met, and structured telemedicine-supported follow-up. Preoperative management includes reduced fasting, carbohydrate loading, and risk-adapted thromboprophylaxis. Intraoperative management includes systematic antiemetic prophylaxis, targeted oxygen delivery, and minimization of unnecessary drug and material use according to a "do not open unless needed" approach. The operating room workflow is also organized to reduce waste through modular instrument sets opened only if required, reduced use of disposable devices, monitoring of personnel present in the room, and segregation of waste into predefined categories for environmental assessment. Postoperatively, the pathway promotes early oral intake, early mobilization, short ambulatory observation, same-day discharge when clinically appropriate, telemedicine review at 7 days, and suture removal either in clinic or through local primary care support.
In the control arm, participants undergo the same underlying surgical indication and reconstructive strategy within the hospital's usual care pathway. Standard care includes inpatient admission, perioperative management according to routine anesthetic and surgical practice, postoperative ward stay, and in-person postoperative follow-up. In this arm, anesthesia technique, airway management, instrument preparation, and operating room waste handling are left to standard institutional practice and clinician preference rather than protocolized sustainability measures.
The study is centered on early postoperative pain control as the primary efficacy objective and 30-day postoperative safety as a key safety objective. In addition, the protocol prospectively evaluates postoperative recovery, patient-reported outcomes, healthcare use, and environment-related outcome measures. Patient-reported assessments include global and breast-specific quality of life, reconstruction-related satisfaction and well-being, general health status, satisfaction with care, telemedicine satisfaction, and chronic postsurgical pain over follow-up. Environment-related measures quantify the carbon footprint of the care pathway through transport-related burden, operating room waste and resource use, and hospitalization-related impact.
The statistical framework includes randomized group comparison with intention-to-treat as the primary analytic approach, supported by per-protocol and safety analyses. The trial is powered on a non-inferiority hypothesis for early postoperative pain control. Based on the protocol assumptions, the planned enrollment is 100 participants overall, with 50 participants per group. Because uncommon postoperative adverse events would require a much larger sample size for a formal non-inferiority demonstration, the 30-day safety endpoint will be interpreted primarily through effect estimates and confidence intervals, with an additional supportive non-inferiority analysis specified in the protocol.
Overall, AMADeuS is intended to test a structured model of breast surgery that combines oncologically standard mastectomy and immediate prepectoral reconstruction with awake perioperative management, day-surgery organization, telemedicine-enabled follow-up, and sustainability-oriented operating room practices. The study is designed to evaluate whether this pathway can support a broader transition toward more efficient, patient-centered, and environmentally responsible surgical care without compromising early clinical outcomes.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
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**Inclusion Criteria:**
**Exclusion Criteria:**
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
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
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.
Standard 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.
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 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.
Time frame: Within 30 days after surgery
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 surgery
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 surgery
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 surgery
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 surgery
Time to mobilization
Time from the end of surgery to first mobilization, measured in hours.
Time frame: Within 48 hours after surgery
Same-day discharge rate
Proportion of participants discharged on the day of surgery.
Time frame: Day of surgery
Length of hospital stay
Total postoperative hospital stay, measured in days.
Time frame: Within 30 days after surgery
Chronic postsurgical pain at 3 months
Presence of chronic postsurgical pain at 3 months, defined by persistent pain with Numeric Pain Rating Scale (NPRS) score 3 or higher, with evaluation of weekly pain frequency and functional interference.
Time frame: 3 months after surgery
Chronic postsurgical pain at 6 months
Presence of chronic postsurgical pain at 6 months, defined by persistent pain with Numeric Pain Rating Scale (NPRS) score 3 or higher, with evaluation of weekly pain frequency and functional interference
Time frame: 6 months after surgery
Global health-related quality of life
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scores over follow-up.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Breast cancer-specific quality of life
Change in European Organisation for Research and Treatment of Cancer breast cancer module scores (EORTC QLQ-BR42) over follow-up.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Care pathway utilization
Organizational outcomes including number of outpatient visits, number of telemedicine visits, total duration of the care pathway in days, and involvement of primary care support.
Time frame: From surgery through 12 months after surgery
Reconstruction-related satisfaction and well-being
Change in BREAST-Q Reconstruction scores over follow-up.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
General health status
Change in Short Form-36 Health Survey (SF-36) scores over follow-up.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Operating room resource use
Operating room resource use, including operating room time, number of personnel present, number and type of surgical kits opened, and use of disposable devices.
Time frame: During surgery
Satisfaction with care
Change in Patient Satisfaction Questionnaire Short Form (PSQ-18) scores over follow-up.
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months
Telemedicine satisfaction
Telemedicine Satisfaction Questionnaire (TSQ) scores among participants managed in the AMADeuS pathway.
Time frame: 1 month, 3 months, 6 months, and 12 months
Carbon footprint from waste generation
Estimated carbon dioxide equivalent emissions associated with operating room and care pathway waste, based on measured waste categories.
Time frame: From Admission to surgical room, until hospital discharge
Carbon footprint from transport
Estimated carbon dioxide equivalent emissions related to participant travel, based on distance traveled and hospital accesses avoided.
Time frame: From surgery through 30 days after surgery
Carbon footprint from hospitalization
Estimated carbon dioxide equivalent emissions related to hospital stay, based on length of stay and bed-day emission factors.
Time frame: Within 30 days after surgery
Plan to share: Undecided — De-identified individual participant data underlying the results reported in publications may be shared with qualified researchers on reasonable request after publication of the primary results. Data sharing will be subject to institutional approval, compliance with applicable privacy and data protection regulations, and execution of an appropriate data sharing agreement.
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