Recruiting

A Comparative Study of Nipple Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, Robotic Techniques

ClinicalTrials.gov IDNCT07062458

PhaseNot Applicable

Enrollment90

SponsorCandiolo Cancer Institute - IRCCS

Age18 Years and older

SexFEMALE

I'm interested View official listing

Conditions studied

Sensation Disorder

About this study

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)

Interventions

Diagnostic Test: Nipple Sensation Assessment — 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. 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.

Primary outcomes

measurement of nipple sensation preservation (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.)

Eligibility information

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).

Study locations

Candiolo Cancer Institute FPO-IRCCS, Torino, 10060 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-15.