Study of Video-Assisted Nipple and Skin Sparing Mastectomy with Immediate Prepectoral Implant Reconstruction Evaluating Safety, Feasibility, Quality of Life, and Cosmetic Outcomes in Women with Early or High-Risk Breast Cancer

What this Trial Is About

Researchers are studying a new technique for nipple skin sparing mastectomy using video-assisted methods like endoscopy or robotics. This study aims to compare this approach with traditional open mastectomy to see if it is at least as effective, focusing on how feasible the technique is, its safety in cancer treatment, and how it looks cosmetically. The study is observational and involves women who need mastectomy but do not require skin reduction or removal. The treatment being studied is a nipple skin sparing mastectomy performed with video assistance, either endoscopic or robotic. Participants undergo immediate breast reconstruction using a prepectoral implant. The study will observe the outcomes of this technique without randomization or a placebo group, focusing on women who have breast cancer or are at high risk for it. Participants will be followed to monitor several outcomes, including implant loss during the first year after surgery, local cancer relapse over five years, remaining glandular breast tissue within the first year, and overall survival at five years. Quality of life and cosmetic results will also be assessed using questionnaires. The study expects to track participants for up to five years to gather comprehensive data on safety, feasibility, and patient experience.

Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy