Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Number of participants with positive margins

The pathologist will assess margin status in patients undergoing SPrNSM

Time frame: 2 weeks following date of surgery

Number of participants with new breast cancers

The PI will assess new breast cancers.

Time frame: following date of surgery up to 5 years

Number of participants with recurrent breast cancers

The PI will assess recurrent breast cancers.

Time frame: following date of surgery up to 5 years

Patient satisfaction as measured by BREAST-Q reconstruction tool

Patient satisfaction is measured by BREAST-Q reconstruction tool at baseline, postoperatively at 2 weeks, and every 6 months for 5 years. BREAST-Q reconstruction module and Breast implant illness survey for patients. Questions about self-confidence, comfort, acceptance of new appearance, feeling of implants, breast pain. The score represents questionnaires about different domains and each question has four possible dimensions. The values of these dimensions varies from 1 (minimum score- worst outcome) to 4 or 5 (maximum score- best outcome) (Likert Scale) depending on part of the questionnaire .

Time frame: Baseline, postoperatively at 2 weeks, every 6 months for 5 years

Patient satisfaction as measured by BREAST-Q sensation tool

Patient satisfaction is measured by BREAST-Q sensation tool at baseline, postoperatively at 2 weeks, and every 6 months for 5 years and it is another tool to help quantify breast sensation both pre-operatively and post-operatively. The Breast-Q is comprised of 2 domains - i) Satisfaction domains and ii) Well-being domains, which are further divided into sub-domains. We will be using 3 satisfaction sub-domains: i) Satisfaction with breasts ii) Satisfaction with Nipple iii) Satisfaction with outcome and 3 well-being sub-domains: i) Psychosocial well-being ii) Sexual well-being and iii) Physical well-being. The values range from 1 (minimum score- worst outcome) to 4 or 5 (maximum score- best outcome) (Likert Scale) depending on part of the questionnaire.

Time frame: Baseline, postoperatively at 2 weeks, every 6 months for 5 years

Degree to which the patients maintain nipple sensation as measured by Semmes Weinstein monofilament tool at baseline

Degree to which the patients maintain nipple sensation will be measured by Semmes Weinstein monofilament tool at baseline, postoperatively at 2 weeks, and every 6 months for 5 years. Monofilament diameter and force will be measured at 9 different locations of the breast to determine the degree of sensation.

Time frame: Baseline, postoperatively at 2 weeks, every 6 months for 5 years

Incidence of short term complications

Reconstruction outcomes is measured by short term complications (wounds, infections, seromas, and device exchange or loss) that occur post-operatively after surgery Short term complications will be described using the NCI CTACAE v. 4.03 criteria.

Time frame: Post-operatively at 30 days

Incidence of long term complications

Long term complications will be described using the NCI CTACAE v. 4.03 criteria and will refer to any medical occurrence directly attributed to the surgical procedure up to 5 years following use of the SP robotic platform and ADM. Grade 3, 4, or 5 complication or adverse event will constitute an event.

Time frame: Following surgery up to 5 years