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

NCT07062458 | Recruiting

• 2 other identifiers: NIPSENSE00043/2025
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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)

Conditions

Sensation Disorder

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

Outcome Measures

Primary Outcomes (1)

• measurement of nipple sensation preservation

  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.

  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.

Secondary Outcomes (3)

• surgical outcomes

  from enrollment to 3 months

• anatomopathological findings

  30-60 days post-surgery

• PROMs

  From enrollment to 6 monts postoperatively

Study Arms (3)

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.

Diagnostic Test: Nipple Sensation Assessment

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

Diagnostic Test: Nipple Sensation Assessment

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.

Diagnostic Test: Nipple Sensation Assessment

Interventions

Nipple Sensation Assessment DIAGNOSTIC_TEST

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.

Conventional Nipple-Sparing Mastectomy (C-NSM); Endoscopic Nipple-Sparing Mastectomy (E-NSM); Robotic Nipple-Sparing Mastectomy (R-NSM)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of female patients aged 18 years or older, eligible for mastectomy for early-stage breast cancer or high-risk conditions, who meet the study eligibility criteria. A total of 90 patients will be recruited at Candiolo Cancer Institute in Torino (Italy).

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Candiolo Cancer Institute - IRCCS: lead

Study Sites (1)

Candiolo Cancer Institute FPO-IRCCS

Torino, 10060, Italy

RECRUITING

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Related Links

• Institution Official Website

MeSH Terms

Conditions

Sensation Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Giada Pozzi, MD

  Candiolo Cancer Institute FPO-IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giada Pozzi, MD

CONTACT

+39 011 9933017; giada.pozzi@ircc.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 14, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: IPD Sharing Time Frame: from 6 months to 24 months after end of recruitment
• Access Criteria: Institutions involved in breast cancer research will be able to request access by directly contacting the PI and coordinating center of the study

Locations

IT (1)