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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Candiolo Cancer Institute FPO-IRCCS
RECRUITING
Torino
Contact Information
Primary
Giada Pozzi, MD
giada.pozzi@ircc.it
+39 011 9933017
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 90
Treatments
Conventional Nipple-Sparing Mastectomy (C-NSM)
Participants in this group will undergo a standard open nipple-sparing mastectomy using traditional surgical instruments. The procedure is performed through a visible incision on the breast, while preserving the nipple and surrounding skin. An implant is placed for immediate reconstruction.
Endoscopic Nipple-Sparing Mastectomy (E-NSM)
This group will receive a minimally invasive nipple-sparing mastectomy using an endoscopic technique. The breast tissue is removed through a small incision in the armpit using a camera and specialized instruments. An implant is placed during the same surgery
Robotic Nipple-Sparing Mastectomy (R-NSM)
Participants in this group will undergo a robotic-assisted nipple-sparing mastectomy. The surgery is performed using a robotic surgical system through a small armpit incision, offering enhanced precision and visualization. Immediate implant reconstruction is also performed.
Related Therapeutic Areas
Sponsors
Leads: Candiolo Cancer Institute - IRCCS

This content was sourced from clinicaltrials.gov