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

RECRUITINGSponsored by Candiolo Cancer Institute - IRCCS
Actively Recruiting
SponsorCandiolo Cancer Institute - IRCCS
Started2025-06-01
Est. completion2027-12-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted

Summary

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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).

Conditions3

Breast CancerCancerSensation Disorder

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