Observational Study on Safety and Outcomes of Endoscopic Nipple-Sparing Mastectomy with Immediate Breast Reconstruction in Adult Women with Breast Cancer

What this Trial Is About

Researchers are observing women undergoing endoscopic nipple-sparing mastectomy NSM with immediate breast reconstruction, a procedure used for breast cancer treatment or prophylactic mastectomy due to hereditary risk. This study aims to collect real-world data on the feasibility, safety, sensory recovery, quality of life, and long-term oncological outcomes of this minimally invasive surgery. It focuses on adult women eligible for implant-based reconstruction, assessing surgical and cancer-related results over several years. Participants undergo endoscopic NSM through a lateral inframammary incision combining open and endoscopic techniques, with intraoperative assessments and axillary staging performed when needed. Immediate prepectoral implant-based reconstruction follows the surgery. No experimental treatments or changes to usual care are applied, as this is an observational study capturing outcomes from routine clinical practice. Throughout the study, data on clinical, surgical, pathological, and follow-up evaluations are collected, including patient questionnaires on satisfaction and quality of life. Assessments occur before surgery, during, and at multiple time points up to five years after surgery. Researchers monitor surgical complications, nipple-areola complex sensation recovery, cancer recurrence, survival, and aesthetic results. Each participant is followed for five years to evaluate long-term safety and effectiveness.

EndoBreast Study - Assessment of Feasibility, Functional Outcomes, and Sensitivity of the Areola-Nipple Complex in Endoscopic Mastectomy