Clinical Trial

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

Study acronym: NIPSENSE
Recruiting
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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)
Trial Details
NCT Number NCT07062458
Lead Sponsor Candiolo Cancer Institute - IRCCS
Conditions Sensation Disorder
Enrollment 90 participants
Start Date 2025-06-01
Primary Completion 2027-12-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-14