Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Nipple-Sparing Mastectomy | Experimental | Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Nipple-Sparing Mastectomy | Other | Patient will undergo to nipple sparing mastectomy and breast reconstruction, conducted using robot |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgery time | Evaluation of average length of robotic procedure | 1 month |
| Post operative complications | Number of post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma) | 1 month |
| Post operative pain | Evaluation of postoperative pain by White and Song scale (minimum value: 0, maximum value: 2 - lower scores indicate higher pain) | 1 month |
| Length of stay of patients | Evaluation of average length of stay of patients | 1 month |
| Patient quality of life after surgery | Completion of BREAST-Q questionnaire (higher answers to each item reflect a better outcome) | 5 years |
| Patient satisfaction regarding body image | Completion of Hopwood's body image scale (BIS) questionnaire (minimum value: 0, maximum value: 3 - higher scores indicate lower satisfaction) | 5 years |
| Patient satisfaction reagarding nipple areola complex | Completion of Nipple Areola Complex (NAC) questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of local recurrence | Number of local recurrence | 5 years |
| Cumulative incidence of axillary recurrences | Number of axillary recurrences |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paolo Veronesi, MD | Contact | +39 0294371091 | paolo.veronesi@ieo.it | |
| Mara Negri | Contact | +39 0257489536 | mara.negri@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Paolo Veronesi, MD | European Istitute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Milan | 20141 | Italy |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Single center prospective trial
Not provided
Not provided
Not provided
Not provided
| 5 years |
| Cumulative incidence of distant recurrences | Number of distant recurrences | 5 years |
| Disease-free survival (DFS) | Interval from surgery to recurrence of disease | 5 years |
| Overall survival (OS) | Interval from surgery to death or last known alive date | 5 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |