Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study

The purpose of this clinical trial is to demonstrate the superiority of sensory recovery following sensory nerve coaptation compared with no sensory nerve coaptation in patients undergoing nipple-sparing mastectomy with immediate breast reconstruction. Breast sensation, including sensation of the nipple-areolar complex, may be diminished or lost following mastectomy because of injury to the sensory nerves supplying the breast skin and nipple-areolar complex. Sensory nerve coaptation may improve sensory recovery after surgery. This study will compare sensory recovery between patients who undergo sensory nerve coaptation and those who do not, with the aim of evaluating whether sensory nerve coaptation improves postoperative breast sensation.

Inclusion Criteria: 1. Patients aged 20 years or older with histopathologically confirmed invasive breast cancer. 2. Patients scheduled to undergo nipple-sparing mastectomy and immediate implant-based breast reconstruction in the subpectoral space for breast cancer. 3. Regardless of the history of pre- or post-operative chemotherapy, or the planned receipt of post-operative radiation therapy. 4. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Patients who have provided written informed consent prior to the initiation of the study. Exclusion Criteria: 1. Patients with a prior history of breast surgery (e.g., benign breast tumor excision, breast cancer surgery, breast augmentation, breast reduction, etc.). 2. Patients who cannot undergo nipple-sparing mastectomy. 3. Patients with bilateral breast cancer. 4. Patients with a history of cancers other than breast cancer diagnosed within the past 5 years (excluding adequately treated non-melanoma skin cancer and thyroid cancer). 5. Patients with pathologically or radiologically confirmed systemic metastasis. 6. Patients with inflammatory breast cancer, neuroendocrine tumor, or malignant phyllodes tumor. 7. Pregnant or breastfeeding patients. 8. Patients who have difficulty understanding the informed consent form.