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| ID | Type | Description | Link |
|---|---|---|---|
| L2-605 | Other Identifier | Comitato Etico Territoriale Lombardia 2 |
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Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety. The procedure will be carried out by a dedicated surgical team in which at least one operator holds certified laparoscopic surgical training issued by a recognized scientific society, ensuring appropriate technical expertise and adherence to surgical safety standards.
This pilot study aims to prospectively document the technical feasibility and perioperative outcomes of E-NSM performed according to an established institutional protocol, including standardized perfusion assessment using indocyanine green (ICG) angiography and patient-reported outcomes using BREAST-Q questionnaire. Data generated from this study will support refinement of the institutional protocol and inform the design of future comparative or multicentre trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) | Experimental | All enrolled patients will undergo endoscopic video-assisted nipple-sparing mastectomy (E-NSM) with immediate breast reconstruction (implant-based or pre-planned alternative reconstruction). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) | Procedure | Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety. Recent prospective studies and meta-analyses have shown encouraging results in terms of technical feasibility, reduced flap-related complications, and higher patient satisfaction compared with the conventional open approach. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of completion of the procedure endoscopically without conversion to open surgery. | Number of procedure not converted to open surgery on the total of study procedures. | At surgery |
| Surgery time | Average and median duration of endoscopic dissection, including creation of the working space. | At surgery |
| Feasibility of immediate reconstruction | The feasibility and type of immediate reconstruction performed (direct-to-implant or two stage) measured as the number immediate rescotruction on the number of total surgery performed. | At surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eleonora Meduri, MD | Contact | +39 02 57489 725 | eleonora.meduri@ieo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Europeo di Oncologia | Recruiting | Milan | 20141 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |