This is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system.
Robotic assisted nipple sparing mastectomies with multi-port robots, like the Da Vinci Xi, have been described previously but pose significant hurdles due to the small area like the breast. The Single-Port da Vinci SP (Intuitive Surgical), which was designed for application to small cavity surgery, may be more appropriately suited for this procedure. This is a prospective registry trial to study the outcomes of performing a single-port robot-assisted nipple sparing mastectomy. Subjects who undergo rNSM and bilateral breast reconstruction of the affected breast via single site small hidden axillary scar technique will be offered participation in the prospective registry trial at their pre-operative visit in the UT Southwestern Breast Clinic. The patient will then be seen at their regularly scheduled clinic appointments at 2 weeks, 1 month, 6 months, and 1 year post operatively at both Breast and Plastics and Reconstructive Surgery (PRS) departments. Outcomes will be tracked in a prospectively kept electronic registry.
Study Type
OBSERVATIONAL
Enrollment
10
UT Southwestern Medical Center
Dallas, Texas, United States
Feasibility of completion of SPrNSM through axillary incision
Measure number of patients who completed surgery with en bloc removal of the breast through axillary incision v. conversion to open incision
Time frame: Up to 1 year
Complication rate of patients requiring re-operation
Number of patients with bleeding requiring a second surgery after SPrNSM
Time frame: Up to 1 year
Complication rate of patients with infection requiring explantation of tissue expander
Number of patients with infection after surgery requiring explantation of tissue expander
Time frame: Up to 1 year
Complication rate of patients with mastectomy flap necrosis
number of patients with skin, or nipple-areolar flap necrosis using SKIN flap score
Time frame: Up to 1 year
Operative surgery time trends with peri-operative outcomes
Measure total surgery time in relation to other outcomes in each patient
Time frame: Up to 1 year
Patient reported outcomes
Patient satisfaction is measured using BREAST-Q. Possible scores range from 1-10 Likert scale, with higher scores indicating better/ worse outcome.
Time frame: Up to 1 year
Patient reported outcomes
Skin and nipple sensation post operatively with Semmes Weinstein monofilament exam
Time frame: Up to 1 year
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