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

NCT07062458 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2025-07-14

No results posted yet for this study

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)

Conditions

  • Sensation Disorder

Interventions

DIAGNOSTIC_TEST

Nipple Sensation Assessment

the measurement of nipple sensation preservation, will be conducted using the Semmes-Weinstein esthesiometer. The clinician will use the device to touch the nipple and the surrounding quadrants of the skin, applying filaments of increasing calibers (0.07gr, 0.4gr, 2.0gr, 4.0gr, 300gr), and the lightest caliber perceived by the patient will be recorded. This assessment will be conducted at four different times: * Before surgery, to assess baseline sensation. * 1 month after surgery. * 3 months after surgery. * 6 months after surgery.

Sponsors & Collaborators

  • Candiolo Cancer Institute - IRCCS

    lead OTHER

Principal Investigators

  • Giada Pozzi, MD · Candiolo Cancer Institute FPO-IRCCS

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-12-01
Completion
2027-12-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07062458 on ClinicalTrials.gov