Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility of completion of SPrNSM through axillary incision
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects age >= 18 years who undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW
排除标准
- •Subjects who are <18 years of age
- •Subjects who do not undergo robotic nipple sparing mastectomy and breast reconstruction with prosthesis at UTSW
结局指标
主要结局
Feasibility of completion of SPrNSM through axillary incision
时间窗: 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
时间窗: 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
时间窗: Up to 1 year
Number of patients with infection after surgery requiring explantation of tissue expander
Operative surgery time trends with peri-operative outcomes
时间窗: Up to 1 year
Measure total surgery time in relation to other outcomes in each patient
Complication rate of patients with mastectomy flap necrosis
时间窗: Up to 1 year
number of patients with skin, or nipple-areolar flap necrosis using SKIN flap score
次要结局
- Patient reported outcomes(Up to 1 year)
研究者
Deborah Farr
Assistant Professor
University of Texas Southwestern Medical Center