This trial studies the side effects of robot-assisted nipple sparing mastectomy (RNSM) using the da Vinci surgical system. Nipple sparing mastectomy (NSM) preserves the skin and nipple areola complex for improved body image and patient satisfaction, but it is technically demanding and has inconsistent outcomes. RNSM is minimally invasive and has the potential to improve the safety and effectiveness of NSM. This may increase patient eligibility for nipple sparing mastectomy while optimizing its surgical and oncologic safety and patient reported outcomes.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04537312.
PRIMARY OBJECTIVES:
I. To generate preliminary data on the safety, efficacy, and risk of complications from RNSM.
II. Investigate the total duration of the operation, the frequency of conversion to open technique, the length of hospitalization, and post-operative complications.
SECONDARY OBJECTIVES:
I. To define the ergonomic challenges and benefits of RNSM to the operating surgeons.
II. To define patient reported outcome and patient satisfaction after RNSM.
III. To define the breast and nipple areolar complex sensation recovery after RNSM.
EXPLORATORY OBJECTIVE:
I. To gain technical familiarity in performing RNSM.
OUTLINE:
Patients undergo sentinel lymph node biopsy followed by RNSM.
After completion of study treatment, patients are followed up at 14 and 30 days, 6 weeks, 6 and 12 months, then periodically up to 5 years.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorSara Myers
