Actively Recruiting
A Comparative Study of Nipple Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, Robotic Techniques
Led by Candiolo Cancer Institute - IRCCS · Updated on 2025-07-14
90
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Comparative Study of Nipple Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, Robotic Techniques
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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).
AI-Screening
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Trial Site Locations
Total: 1 location
1
Candiolo Cancer Institute FPO-IRCCS
Torino, Italy, 10060
Actively Recruiting
Research Team
G
Giada Pozzi, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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