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A Comparative Study of Nipple Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, Robotic Techniques
NCT07062458 · Candiolo Cancer Institute - IRCCS · Updated 14 July 2025
- What is being tested
- Nipple Sensation Assessment
- For
- Sensation Disorder
- Kind of study
- Watches patients without assigning a treatment. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 90 people. The full rules are on the registry page.
- Where
- Italy
- When
- Starts or started 1 June 2025, ends 1 Dec 2027. Registered 14 July 2025.
- Results
- None posted yet.
In the researchers' words
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)
Sites
- Candiolo Cancer Institute FPO-IRCCSTorino, Italy
