Sensation Disorder
Conditions
Keywords
Nipple sensation, Sensory outcomes, Quality of life, Endoscopic breast surgery, Robotic breast surgery, Breast cancer surgery, Nipple-sparing mastectomy, Breast reconstruction, R-NSM, E-NSM, conventional mastectomy
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 Tissue analysis to explore whether preserved nerve structures are related to the level of sensation after surgery This study will provide important data about how surgical methods impact physical and emotional outcomes for people undergoing mastectomy. The findings may help improve patient care and inform future decisions about surgical approaches to breast cancer treatment.
Interventions
DIAGNOSTIC_TESTNipple 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
Candiolo Cancer Institute - IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measurement of nipple sensation preservation | 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
| Measure | Time frame | Description |
|---|---|---|
| surgical outcomes | from enrollment to 3 months | nipple-areola complex necrosis, skin flaps necrosis, infection, bleeding, seroma, wound dehiscence, |
| anatomopathological findings | 30-60 days post-surgery | the presence or absence of sensory cutaneous receptors in the subcutaneous layer of the specimen and their possible correlation to the degree of cutaneous sensation |
| PROMs | From enrollment to 6 monts postoperatively | Questionnaires will be administered to the patients to assess patient-reported outcomes: Hopwood Body Image Scale (score 0 to 30, higher scores meaning a worst outcome), and EORTC - European Organisation for Research and Treatment of Cancer, BR-23 questionnaire (no total score, each question compared individually between groups) |
Countries
Italy
Contacts
Primary ContactGiada Pozzi, MD
Outcome results
None listed