NIPSENSE - A Comparative Study of Nipple and Skin Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, and Robotic Techniques
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- measurement of nipple sensation preservation
Study Overview
Brief 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)
Detailed Description
The NIPSENSE study is a prospective, single-center study comparing how well nipple sensation is preserved after three types of nipple-sparing mastectomy (NSM): Conventional NSM (C-NSM), Endoscopic NSM (E-NSM), and Robotic NSM (R-NSM). The goal is to better understand the sensory and quality-of-life outcomes associated with each technique.
A total of 90 female participants (30 in each group) will be recruited. All will undergo NSM with direct-to-implant reconstruction. Participants will be assessed for nipple and skin sensation before surgery, and again at 1, 3, and 6 months after surgery, using a standard medical tool called the Semmes-Weinstein esthesiometer.
The study will also evaluate:
Surgical complications (e.g., infection, bleeding, skin necrosis)
Patient-reported outcomes using validated tools like the Hopwood Body Image Scale and EORTC questionnaires
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
measurement of nipple sensation preservation
Time Frame: 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.
The primary objective, 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.
Secondary Outcomes
- surgical outcomes(from enrollment to 3 months)
- anatomopathological findings(30-60 days post-surgery)
- PROMs(From enrollment to 6 monts postoperatively)
Investigators
Giada Pozzi
MD
Candiolo Cancer Institute - IRCCS