About this trial
Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women who require a mastectomy and who do not require skin reduction or resection are included. Women with both breast cancer and those at high risk for breast cancer are included.
Disqualifiers
Sarcomas of the breast.
Benign breast tumors.
Prepectoral reconstruction with expansion.
Impossibility to preserve the skin.
Trial population
Patient with breast cancer or high risk for breast cancer who need a mastectomy. The mastectomy will be skin and nipple preserving and will be performed with endoscopic assistance
Trial design
Other
Prospective
Treatments tested in this trial
Video assisted mastectomy
Other interventionNipple Skin sparing mastectomy assisted by endoscopic or robotic
Treatment groups
Trial outcomes
Primary outcomes
Implant Loss
Safety of the reconstruction technique, calculated by the number of implants lost
Secondary outcomes
local relapse
evaluate oncological safety in terms of local relapses
Glandular residual tissue
Residual glandular tissue after endoscopic mastectomy identified by magnetic resonance imaging one year after the intervention
Suvival
Overall survival
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Alejandra García-Novoa
Lead sponsor
University Hospital A Coruña
Sponsor institution