About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Previous breast surgery.
History of radiation therapy to the chest/breast area.
Active or non-controlled diabetes mellitus.
Neuropathies causing potentially altered skin sensation.
Trial design
Treatments tested in this trial
- Nipple Sensation Assessment