Necrosis After Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 566
- 试验地点
- 1
- 主要终点
- Necrosis complications within one month post operation
研究概览
简要总结
The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery. The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery.
详细描述
Breast cancer is the most common cancer among women in the world. Although breast-conserving surgery is a viable option for patients, mastectomy remains the choice of treatment. Despite oncologic and surgical safety of nipple-sparing mastectomy(NSM) with immediate breast reconstruction(IBR) were amply demonstrated, a number of acute and late complications can occur. Surgical technique may play a role in the postoperative outcomes of mastectomy skin flap.Previous studies suggest that cold dissection with scissors or scalpel, may lead to decreasing blood loss and rates of skin necrosis, compared to electrocautery. A retrospective study by Troy Ng demonstrated that the use of cold dissection is likely to decrease the rate of partial-thickness necrosis (13.0%→33.3%, p=0.01) and full-thickness necrosis (1.3%→12.8%, p=0.02). The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Tumor smaller than 5 cm
- •No evidence of NAC, skin or chest wall invasion.
- •The general inclusion criteria or pre-requisite for nipple sparing mastectomy apply to E-NSM as well.
排除标准
- •Patients with apparent NAC involvement, chest wall or skin invasion, inflammatory breast cancer, locally advanced breast cancer or severe comorbid conditions or poor performance status assessed by the primary physicians, such as heart disease, renal failure, liver dysfunction, and poor performance status as assessed by the primary physicians.
结局指标
主要结局
Necrosis complications within one month post operation
时间窗: Within one month post operation
Necrosis complications included nipple-areolar complex (NAC) and skin flap necrosis. NAC/skin flap necrosis could present as minor superficial epidermolysis requiring local wound care only, or full-thickness necrosis with any exposure of acellular dermal matrix, muscle, implant, or with full-thickness eschar that required surgical reoperation of debridement and repair.
次要结局
- Necrotic complications within 1 year post operation(Within 1 year post operation)
- Surgical-site infection rate(SSI)(within one year post operation)
- Patient-reported outcomes (as measured using the BREAST-Q score)(Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.)
- The incidence of postoperative complications(within one year post operation)
- Cosmetic outcomes evaluated by 5-point Likert Scale(Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.)
- Postoperative pain(Evaluated at the first day, second day, third day and the first week, second week.)
- Total operation time(Immediate post operation)
- Drain volume(within three days post operation)
- Intraoperative estimated blood loss(Immediate post operation)
- Duration of hospital stay post operation(Within 2 weeks of operation.)
- Weight of the excised gland(Immediate post operation)
- Size of implant(Immediate post operation)