An Exploration of 3D Printing Technology for Preoperative Evaluation in Reducing Ischemic Complications of Flap and Nipple-Areolar Complex (NAC) After Nipple-sparing Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Ischemic complications of flap and nipple areola complex
研究概览
简要总结
The goal of this clinical study is to explore whether preoperative application of 3D printing technology to evaluate breast blood supply can improve the occurrence of ischemic complications in the flap and nipple areola complex after surgery.
详细描述
Preoperatively, 3D printing technology was applied to assess the blood supply of the breast, and intraoperatively, the flap was separated using a cold knife combined with an electrosurgical knife, and comparisons were made between the flap and the conventional electrosurgical knife to observe whether there was a difference in the incidence of ischemic complications in the nipple areola complex and the flap and whether the use of 3D printing technology in preoperative assessment was able to effectively reduce the occurrence of ischemic complications in the postoperative period.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed diagnosis of breast cancer
- •Age: 18 to 70 years old
- •No infiltration of the nipple-areola complex and negative histopathology of the nipple basal margins;
- •Patients who meet the indications for breast conserving surgery require total mastectomy and reconstruction;
排除标准
- •Inability to tolerate surgery or subjective desire not to undergo nipple-sparing mastectomy;
- •Patients with clinical or imaging evidence of preoperative involvement of the nipple/areolar region, including Paget's disease, nipple spillage, inflammatory breast cancer, and/or imaging findings suggesting malignant involvement of the nipple or subareolar tissues, according to the 2023 NCCN guideline recommendations, where retaining the NAC fails to yield negative margins;
结局指标
主要结局
Ischemic complications of flap and nipple areola complex
时间窗: 1 week and 2 week after surgery
The incidence of ischemic complications in the skin flap and nipple areola complex after NSM surgery
次要结局
- Severity of ischemic complications in the flap and nipple areola complex(1 week and 2 week after surgery)
- Duration of surgery(postoperative)
- Blood loss(Preoperative and 2 hours postoperatively)
- Breast-Q Satisfaction(Preoperative, 3 months and 1 year postoperatively)
研究者
Kun Wang
Professor
Guangdong Provincial People's Hospital