Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anatomic Stage IA Breast Cancer AJCC v8
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Feasibility of completion of SPrNSM through axillary incision
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Deborah Farr
Assistant Professor
University of Texas Southwestern Medical Center
Eligibility Criteria
Inclusion Criteria
- •Subjects age \>= 18 years who undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW
Exclusion Criteria
- •Subjects who are \<18 years of age
- •Subjects who do not undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW
Outcomes
Primary Outcomes
Feasibility of completion of SPrNSM through axillary incision
Time Frame: Up to 1 year
Measure number of patients who completed surgery with en bloc removal of the breast through axillary incision v. conversion to open incision
Complication rate of patients requiring re-operation
Time Frame: Up to 1 year
Number of patients with bleeding requiring a second surgery after SPrNSM
Complication rate of patients with infection requiring explantation of tissue expander
Time Frame: Up to 1 year
Number of patients with infection after surgery requiring explantation of tissue expander
Operative surgery time trends with peri-operative outcomes
Time Frame: Up to 1 year
Measure total surgery time in relation to other outcomes in each patient
Complication rate of patients with mastectomy flap necrosis
Time Frame: Up to 1 year
number of patients with skin, or nipple-areolar flap necrosis using SKIN flap score
Secondary Outcomes
- Patient reported outcomes(Up to 1 year)