An Exploration of 3D Reconstruction Tool 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 reconstruction tool can reduce the occurrence of ischemic complications in the flap and nipple areola complex after surgery.
详细描述
The 3D reconstruction tool was applied preoperatively to assess the blood supply and volume of participants' breasts and to recommend personalized prosthesis volume. Compared with electrosurgical knife separation，the flap was separated intraoperatively using a combination of cold knife and electrosurgical knife to observe whether there was a difference in the incidence of ischemic complications of participants' nipple areola complex and flap, and whether the use of the 3D tool in the preoperative assessment was effective in reducing the occurrence of postoperative ischemic complications.
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;
- •Participants 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;
- •Participants 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;
研究组 & 干预措施
3D-reconstruction group
The participant's breast blood supply was assessed preoperatively using 3D reconstruction technology, and the flap was separated intraoperatively using a combination of electrocautery and sharp dissection.
干预措施: 3D reconstruction technology (Procedure)
Normal group
Participants are not evaluated preoperatively using 3D reconstruction technology and flap separation is performed using electrosurgical knife intraoperatively.
干预措施: 3D reconstruction technology (Procedure)
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