Life sciences · Interventional Study
ClinicalTrials.gov · September 30, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07850154). This is a study registration, not published results. Lead sponsor: Guangzhou Women and Children's Medical Center. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 374 participants (ESTIMATED). Conditions: Breast Neoplasms. Interventions: PROCEDURE: Robotic-assisted nipple-sparing mastectomy; PROCEDURE: Endoscopic-assisted nipple-sparing mastectomy. Primary outcome measures: Tactile pressure sensation of the nipple-areola complex at 6 months postoperatively , 12 months postoperatively; Positive surgical margin rate , Intraoperative / postoperative (2 weeks after surgery). Brief summary: 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.