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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Istituto Europeo di Oncologia
Milan, Italy
RECRUITINGRate 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.
Time frame: At surgery
Surgery time
Average and median duration of endoscopic dissection, including creation of the working space.
Time frame: 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.
Time frame: At surgery
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