Robotic Nipple Sparing Mastectomy with Immediate Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic Nipple-Sparing Mastectomy.
- Who it may be relevant to
- Registry conditions: Breast Cancer, DCIS, BRCA Mutation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Robotic Nipple Sparing Mastectomy with Immediate Reconstruction with Prepectoral Implant: a Single Center, Prospective Trial
Overview
Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct implant procedure can impact on perioperative and postoperative period and on oncologic outcome.
Detailed description
Muscle coverage, whether total or partial, has been historically advocated as the preferred approach after nipple sparing mastectomy because it adds an additional layer of vascularized coverage to the implant. However, current practices have evolved toward prepectoral implant reconstruction as it reduces animation deformity, pain, and muscle spasms, compared with the subpectoral approach, while maintaining optimal esthetic results. One of the limitations to the use of the prepectoral (subcutaneous) implant in ordinary surgery (open technique) is related to the fact that the implant is in direct contact with the surgical wound, giving reasons of high rate of implant loss due to wound dehiscence.
In this sense, the extra-mammary localization of the surgical wound (as during robotic mastectomy) allows the positioning of the prepectoral implant in greater safety.
Robotic nipple-sparing mastectomy with immediate breast prepectoral implant reconstruction may allow for more precise anatomic dissection and improved cosmetic outcomes over conventional open nipple-sparing mastectomy with retro-pectoral implant reconstruction; however, data about the feasibility, safety of the prepectoral reconstruction is limited as well as Quality of Life (QoL) evaluation.
The aim of this single center, prospective trial is to analyze the perioperative data, postoperative complications, oncologic outcomes as well as to analyze the patient reported outcome measures (PROMs) of 24 consecutive patients undergoing robotic nipple-sparing mastectomy and reconstruction with prepectoral implant. Concomitant endpoint is to compare operative features outcome measures and post-operative outcome complications.
A second-phase time line is to evaluate the long-term analysis of cumulative incidence of loco-regional recurrence, distant recurrences, the disease free survival and the overall survival with a median follow up of 5 years.
Interventions
- Other Robotic Nipple-Sparing Mastectomy
Patient will undergo to nipple sparing mastectomy and breast reconstruction, conducted using robot
Primary outcome measures
- Surgery time [Time frame: 1 month]
- Post operative complications [Time frame: 1 month]
- Post operative pain [Time frame: 1 month]
- Length of stay of patients [Time frame: 1 month]
- Patient quality of life after surgery [Time frame: 5 years]
- Patient satisfaction regarding body image [Time frame: 5 years]
- Patient satisfaction reagarding nipple areola complex [Time frame: 5 years]
Secondary outcome measures (5)
- Cumulative incidence of local recurrence [Time frame: 5 years]
- Cumulative incidence of axillary recurrences [Time frame: 5 years]
- Cumulative incidence of distant recurrences [Time frame: 5 years]
- Disease-free survival (DFS) [Time frame: 5 years]
- Overall survival (OS) [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Candidates to nipple-sparing mastectomy and immediate breast reconstruction for invasive breast cancer, ductal carcinoma in situ (DCIS), BReast CAncer gene (BRCA) mutation carriers
- Any age
- Negative preoperative assessment of nipple-areola complex
- Absence of skin involvement
- Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section
- Breast volume ≤ Bra IV
- No hard smoking (defined as <=20 cigarettes/day)
- Low and intermediate risk for anesthesia (American Society of Anesthesiologists (ASA) Scale)
- Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
- Patients must be accessible for follow-up
Exclusion criteria
- Previous thoracic radiation therapy for any reason
- Inflammatory Breast Cancer
- Pregnancy
- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
- Uncompensated Diabetes Mellitus
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Italy · 1 center
- European Institute of Oncology — Milan
Identifiers
NCT: NCT06860217 · IEO 1649