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NCT07850154
NA

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

Sponsor: Guangzhou Women and Children's Medical Center

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Prospective, Randomized Two-arm Controlled Trial Comparing the Impact of Robotic Versus Endoscopic Surgery on Breast Nerve Function Following Nipple-sparing Mastectomy for Breast Cancer

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

374

Start Date

2026-10-01

Completion Date

2031-10-01

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

PROCEDURE

Robotic-assisted nipple-sparing mastectomy

Robotic-assisted nipple-sparing mastectomy for breast cancer.

PROCEDURE

Endoscopic-assisted nipple-sparing mastectomy

Endoscopic-assisted nipple-sparing mastectomy for breast cancer.

Locations (1)

Guangzhou Women and Children's Medical Center, Guangzhou Medical University

Guangzhou, Guangdong, China