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

Candiolo Cancer Institute - IRCCS

Status: Enrolling

Conditions: Sensation Disorder

Treatments: Diagnostic Test: Nipple Sensation Assessment

Study type: Observational

Funder types: Other

Identifiers

NCT07062458

00043/2025 (Registry Identifier)

NIPSENSE

Details and patient eligibility

About

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)

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

90 participants in 3 patient groups

Conventional Nipple-Sparing Mastectomy (C-NSM)

Description:

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.

Treatment:

Diagnostic Test: Nipple Sensation Assessment

Endoscopic Nipple-Sparing Mastectomy (E-NSM)

Description:

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

Treatment:

Diagnostic Test: Nipple Sensation Assessment

Robotic Nipple-Sparing Mastectomy (R-NSM)

Description:

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.

Treatment:

Diagnostic Test: Nipple Sensation Assessment