Robotic Nipple Sparing Mastectomy with Immediate Reconstruction with Prepectoral Implant: a Single Center, Prospective Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Surgery time
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Robotic Nipple-Sparing Mastectomy
Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction
Intervention: Robotic Nipple-Sparing Mastectomy (Other)
Outcomes
Primary Outcomes
Surgery time
Time Frame: 1 month
Evaluation of average length of robotic procedure
Length of stay of patients
Time Frame: 1 month
Evaluation of average length of stay of patients
Post operative complications
Time Frame: 1 month
Number of post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma)
Post operative pain
Time Frame: 1 month
Evaluation of postoperative pain by White and Song scale (minimum value: 0, maximum value: 2 - lower scores indicate higher pain)
Patient quality of life after surgery
Time Frame: 5 years
Completion of BREAST-Q questionnaire (higher answers to each item reflect a better outcome)
Patient satisfaction regarding body image
Time Frame: 5 years
Completion of Hopwood's body image scale (BIS) questionnaire (minimum value: 0, maximum value: 3 - higher scores indicate lower satisfaction)
Patient satisfaction reagarding nipple areola complex
Time Frame: 5 years
Completion of Nipple Areola Complex (NAC) questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)
Secondary Outcomes
- Cumulative incidence of local recurrence(5 years)
- Cumulative incidence of distant recurrences(5 years)
- Cumulative incidence of axillary recurrences(5 years)
- Disease-free survival (DFS)(5 years)
- Overall survival (OS)(5 years)