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Not Yet Recruiting NCT07850154

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

Conditions: Breast Neoplasms

Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 374
Sponsor: Guangzhou Women and Children's Medical Center

Location: Guangzhou Women and Children's Medical Center, Guangzhou Medical University Guangzhou Guangdong

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.

Eligibility Criteria

Inclusion Criteria: 1. Ductal carcinoma in situ (DCIS), or invasive breast cancer with clinical stage T1-T3, N0-N1 and no distant metastasis; 2. Breast size ≤ cup C, without significant breast ptosis; 3. Patients with high aesthetic requirements who elect single-incision robotic or endoscopic-assisted nipple-sparing mastectomy; 4. Patients eligible for prophylactic mastectomy; 5. Patients understand the study protocol and sign the written informed consent form. Exclusion Criteria: 1. Tumor invasion of the nipple-areola complex, skin, or chest wall; 2. Inflammatory breast cancer; 3. Patients with poor general condition who are unable to tolerate surgery.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07850154). StuddyBuddy aggregates publicly available trial information.