Evaluating Single-Port Robot-Assisted Versus Traditional Open Breast-Conserving Surgery for Early Breast Cancer Safety, Recovery, and Quality of Life Comparison

What this Trial Is About

Researchers are evaluating the safety, feasibility, and quality of life outcomes for single-port robotic surgery compared to traditional open surgery in breast-conserving surgery for breast cancer. The study aims to compare complications, postoperative recovery, and safety to identify a more effective and safer surgical method for early-stage invasive breast carcinoma. Participants who meet the inclusion criteria will join either the single-port robotic surgery group or the open surgery group based on financial considerations and equipment availability. The study involves two surgical procedures breast-conserving surgery using either single-port robotic assistance or traditional open surgery. Before surgery, patients undergo imaging tests like mammography, breast ultrasound, and enhanced MRI to collect disease information. During surgery, data such as operating time, blood loss, and intraoperative complications are recorded. Postoperative periods include monitoring complications, pain scores, pathological biopsy results, and hospital stay length. Follow-ups occur at 28 and 90 days to assess complications and mortality rates, with a 3-year follow-up to evaluate disease-free survival and overall survival. Participants will complete quality of life and psychosocial satisfaction questionnaires at multiple time points up to 36 months after surgery. The primary outcome is the success rate of breast-conserving surgery measured up to 2 weeks post-treatment. Secondary outcomes include quality of life assessments at 1 week, 1, 3, 6, 12, and 24 months after surgery. This study does not use randomization or masking and monitors patients closely through hospital stays and follow-up visits to evaluate safety and recovery.

Application of Single-Port Robot-Assisted Breast-Conserving Surgery Via Axillary Approach for Breast Cancer.