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)
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.
Previous breast surgery.
History of radiation therapy to the chest/breast area.
Active or non-controlled diabetes mellitus.
Neuropathies causing potentially altered skin sensation.
The study population will consist of female patients aged 18 years or older, eligible for mastectomy for early-stage breast cancer or high-risk conditions, who meet the study eligibility criteria. A total of 90 patients will be recruited at Candiolo Cancer Institute in Torino (Italy).
Cohort
Prospective
Nipple Sensation Assessment
Diagnostic testthe measurement of nipple sensation preservation, will be conducted using the Semmes-Weinstein esthesiometer. The clinician will use the device to touch the nipple and the surrounding quadrants of the skin, applying filaments of increasing calibers (0.07gr, 0.4gr, 2.0gr, 4.0gr, 300gr), and the lightest caliber perceived by the patient will be recorded. This assessment will be conducted at four different times: * Before surgery, to assess baseline sensation. * 1 month after surgery. * 3 months after surgery. * 6 months after surgery.
measurement of nipple sensation preservation
The primary objective, the measurement of nipple sensation preservation, will be conducted using the Semmes-Weinstein esthesiometer. The clinician will use the device to touch the nipple and the surrounding quadrants of the skin, applying filaments of increasing calibers (0.07gr, 0.4gr, 2.0gr, 4.0gr, 300gr), and the lightest caliber perceived by the patient will be recorded.
surgical outcomes
nipple-areola complex necrosis, skin flaps necrosis, infection, bleeding, seroma, wound dehiscence,
anatomopathological findings
the presence or absence of sensory cutaneous receptors in the subcutaneous layer of the specimen and their possible correlation to the degree of cutaneous sensation
PROMs
Questionnaires will be administered to the patients to assess patient-reported outcomes: Hopwood Body Image Scale (score 0 to 30, higher scores meaning a worst outcome), and EORTC - European Organisation for Research and Treatment of Cancer, BR-23 questionnaire (no total score, each question compared individually between groups)
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