A Comparative Study of Nipple Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, Robotic Techniques
NCT07062458
Summary
The goal of this comparative study is to learn how different surgical methods affect nipple and skin sensation after nipple-sparing mastectomy (NSM). The study will compare three types of NSM: conventional, endoscopic, and robotic. The main question it aims to answer is: How much nipple sensation do participants keep after each type of surgery? Researchers will also look at surgery-related complications, patient-reported outcomes like body image and quality of life, and tissue analysis to see if there is a link between nerve structures and sensation. Participants will: Have NSM using one of the three surgical approaches Receive breast reconstruction with an implant during the same surgery Complete nipple sensation tests before and at 1, 3, and 6 months after surgery Answer surveys about their quality of life and body image Provide surgical tissue for analysis (as part of the planned procedure)
Eligibility
Inclusion Criteria: * Female patients aged ≥18 years. * Diagnosed with early-stage breast cancer or deemed at high risk for breast cancer (eg. BRCA1-2 mutations). * Candidates for Nipple-Sparing Mastectomy (NSM). * Able to provide informed consent. * No contraindications for surgery based on physical examination and preoperative assessment. * Signed the consent forms and willing to participate in all scheduled follow-up assessments. Exclusion Criteria: * Previous breast surgery. * History of radiation therapy to the chest/breast area. * Active or non-controlled diabetes mellitus. * Neuropathies causing potentially altered skin sensation. * Nipple involvement by cancer, clinical or reported intra-operatively via frozen section analysis (the procedure will be converted to SSM).
Conditions3
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NCT07062458