A Comparative Study of Nipple Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, Robotic Techniques
NCT ID: NCT07062458
Last Updated: 2025-07-14
Study Results
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Basic Information
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RECRUITING
90 participants
OBSERVATIONAL
2025-06-01
2027-12-01
Brief Summary
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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)
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
FEMALE
No
Sponsors
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Candiolo Cancer Institute - IRCCS
OTHER
Responsible Party
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Giada Pozzi
MD
Principal Investigators
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Giada Pozzi, MD
Role: PRINCIPAL_INVESTIGATOR
Candiolo Cancer Institute FPO-IRCCS
Locations
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Candiolo Cancer Institute FPO-IRCCS
Torino, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Related Links
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Institution Official Website
Other Identifiers
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00043/2025
Identifier Type: REGISTRY
Identifier Source: secondary_id
NIPSENSE
Identifier Type: -
Identifier Source: org_study_id
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