This is a multicenter, prospective, randomized parallel controlled two arm clinical trial, designed to systematically evaluate impact of robotic versus endoscopic surgery on breast nerve function in patients undergoing nipple sparing mastectomy for breast cancer. The study will comprehensively assess the neurological functional outcomes, oncological safety, quality of life and sexual health, perioperative efficacy, surgical complications, and health economic value of the two minimally invasive approaches.
This study has been approved by the Institutional Review Board of the Affiliated Women and Children's Medical Center of Guangzhou Medical University. Written informed consent will be obtained from all eligible participants prior to enrollment. All patient data will be anonymized and kept strictly confidential. Statistical analyses will be performed using SPSS 27.0 software, with a P value \< 0.05 set as the threshold for statistical significance.
Ductal carcinoma in situ (DCIS), or invasive breast cancer with clinical stage T1-T3, N0-N1 and no distant metastasis;
Breast size ≤ cup C, without significant breast ptosis;
Patients with high aesthetic requirements who elect single-incision robotic or endoscopic-assisted nipple-sparing mastectomy;
Patients eligible for prophylactic mastectomy;
Tumor invasion of the nipple-areola complex, skin, or chest wall;
Inflammatory breast cancer;
Patients with poor general condition who are unable to tolerate surgery.
Parallel
Robotic-assisted nipple-sparing mastectomy
Procedure/SurgeryRobotic-assisted nipple-sparing mastectomy for breast cancer.
Endoscopic-assisted nipple-sparing mastectomy
Procedure/SurgeryEndoscopic-assisted nipple-sparing mastectomy for breast cancer.
Tactile pressure sensation of the nipple-areola complex at 6 months postoperatively
Tactile pressure sensation will be measured using Semmes-Weinstein monofilaments. The examiner will apply the device to the nipple-areola complex, using filaments of incrementally increasing force (0.07 g, 0.4 g, 2.0 g, 4.0 g, 300 g), and record the lightest filament detectable by the patient.
Positive surgical margin rate
Tactile pressure sensation of the nipple-areola complex and breast skin at multiple postoperative time points
Tactile pressure sensation will be measured using Semmes-Weinstein monofilaments. The examiner will apply the device to the nipple-areola complex and predefined quadrants of the surrounding breast skin, using filaments of incrementally increasing force (0.07 g, 0.4 g, 2.0 g, 4.0 g, 300 g), and record the lightest filament detectable by the patient.
Temperature sensation of the nipple-areola complex and breast skin
Temperature sensation will be assessed at the nipple-areola complex and predefined quadrants of the breast skin. Cold sensation is tested with an ice hammer, and warm sensation is tested using the heating mode of a massage device.
Erection function of the nipple-areola complex
Nipple erection function will be evaluated by stimulation of the nipple-areola complex using the vibration mode of a massage device.
Patient-reported outcomes
Patient-reported breast-specific sensory function, quality of life and sexual well-being will be assessed using the BREAST-Q™ Sensation Module (Pre- and Postoperative) Version 2.0 and BREAST-Q™ Breast Cancer Core Scale (Pre- and Postoperative) Version 2.0 (Sexual Well-being subscale). All subscales yield Rasch-transformed scores ranging from 0 (worst outcome) to 100 (best outcome): higher scores represent better breast sensory function, fewer breast symptoms, less negative quality-of-life impact from breast sensation alteration, and superior sexual well-being, respectively.
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