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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorCandiolo Cancer Institute - IRCCS

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

Treatment groups

90 Participants
are divided into 3 treatment groups