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)

The NIPSENSE study is a prospective, single-center study comparing how well nipple sensation is preserved after three types of nipple-sparing mastectomy (NSM): Conventional NSM (C-NSM), Endoscopic NSM (E-NSM), and Robotic NSM (R-NSM). The goal is to better understand the sensory and quality-of-life outcomes associated with each technique.

A total of 90 female participants (30 in each group) will be recruited. All will undergo NSM with direct-to-implant reconstruction. Participants will be assessed for nipple and skin sensation before surgery, and again at 1, 3, and 6 months after surgery, using a standard medical tool called the Semmes-Weinstein esthesiometer.

The study will also evaluate:

Surgical complications (e.g., infection, bleeding, skin necrosis)

Patient-reported outcomes using validated tools like the Hopwood Body Image Scale and EORTC questionnaires

Tissue analysis to explore whether preserved nerve structures are related to the level of sensation after surgery

This study will provide important data about how surgical methods impact physical and emotional outcomes for people undergoing mastectomy. The findings may help improve patient care and inform future decisions about surgical approaches to breast cancer treatment.

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).

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).

De-identified individual participant data (IPD) will be made available to qualified researchers upon reasonable request, following publication of the primary results. Shared data may include demographic details, surgical outcomes, complications, and patient-reported outcomes. Requests will be reviewed by the study team to ensure appropriate use and compliance with ethical standards. Data sharing will be subject to a data use agreement.

IPD Sharing Time Frame: from 6 months to 24 months after end of recruitment

Institutions involved in breast cancer research will be able to request access by directly contacting the PI and coordinating center of the study