Endoscopic Video-Assisted Nipple-Sparing Mastectomy

Condition(s) studied

Investigational drug(s) / intervention(s)

Endoscopic video-assisted nipple-sparing mastectomy (E-NSM): 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Rate of completion of the procedure endoscopically without conversion to open surgery. — At surgery
  Number of procedure not converted to open surgery on the total of study procedures.
• Surgery time — At surgery
  Average and median duration of endoscopic dissection, including creation of the working space.
• Feasibility of immediate reconstruction — At surgery
  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.

Trial sites (1)

More European Institute of Oncology trials in Italy

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