Prospective Cohort Study Comparing Minimally Invasive and Traditional Surgery for Nipple-Sparing Mastectomy with Immediate Prosthesis Reconstruction

What this Trial Is About

Breast cancer is the most common malignant tumor in women, and surgical treatment is the key approach for early stages of the disease. While breast conserving rates are increasing, many women still require removal of the breast, which can affect their physical appearance and psychological well-being. This research aims to compare two surgical methods for nipple-sparing mastectomy combined with immediate prosthesis breast reconstruction to evaluate differences in safety, complications, and patient satisfaction using a prospective cohort design. The study includes two groups: one undergoing nipple-sparing mastectomy with immediate prosthesis reconstruction using endoscopic or robotic surgery, and the other receiving conventional open nipple-sparing mastectomy with immediate prosthesis reconstruction. The project will enroll patients treated at Peking University People's Hospital from January 2025 to December 2028, focusing on the use of non-biological patches to wrap prostheses during surgery. Participants will be monitored for postoperative complications within three months and followed for up to five years to assess tumor safety through recurrence and survival measures. Patient-reported outcomes will be collected over one year to understand satisfaction and quality of life. Data such as clinical pathology and imaging will be gathered, and only patients able to complete questionnaires and who consent to participate will be included.

Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction