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Impact of Robotic Versus Endoscopic Surgery on Nipple Nerve Function Following Nipple-Sparing Mastectomy for Breast Cancer

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07850154
Lead Sponsor Guangzhou Women and Children's Medical Center
Conditions
(from sponsor)		 Breast Neoplasms
Related terms Breast Neoplasms
Enrollment 374 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov