Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Efficiency of lymphaticovenous anastomosis (LVA)
研究概览
简要总结
This study assesses the performance of robot-assisted microsurgery. Lymphaticovenous anastomosis (LVA) is the most difficult procedure in microsurgery at this moment. The LVA technique is applied to treat for example breast cancer-related lymphedema (BCRL). Therefore, this LVA procedure is compared using a manual expert and the same expert applying robot-assisted LVA.
详细描述
Microsurgery facilitates procedures such as transplantation of tissue as well as lymphedema treatment. Currently, the plastic surgeon's hands are the limiting factor in microsurgical performance. Robot-assistence increases the movement in precision and might therefore be of great importance for the advancement of microsurgery in the world.
It is a prospective study in Maastricht University Medical Center assessing 60 patients undergoing either robot-assisted or manual lymphaticovenous anastomosis (LVA) tot treat breast cancer-related lymphedema (BCRL). The primary outcome parameter is LVA technique. Secondary outcome measures include duration of surgery, technical errors during & complications peri-operatively, surgeon's satisfaction with the LVA procedure, teh patients' convenience during surgery, arm volume over time and patient's symptoms development over time.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender;
- •Treated for primary early stage breast cancer;
- •Early stage lymphedema of the arm (stage 1 or 2 on ISL classification);
- •ELV > 10%;
- •Suffering from unilateral disease.
排除标准
- •Male gender;
- •Stage 3 lymphedema of the arm;
- •Receiving current breast cancer treatment;
- •Distant breast cancer metastases;
- •Current substance abuse;
- •History of marcaine or indocyanine green allergy;
- •Non-viable lymphatic system as determined by near infrared imaging;
- •Previous LVA (<10 years) in the arm with lymphedema.
结局指标
主要结局
Efficiency of lymphaticovenous anastomosis (LVA)
时间窗: Assessed at one moment during, maximally up to 1 year postoperatively
Efficiency of LVA is measured assessing the quality of the LVA using video recordings of the surgery, which is judged by two independent consultants. The Structured Assessment of Microsurgery Skills (SAMS) measuring method is used to assess the quality of each anastomosis. The SAMS score contains twelve separate items, scored from 1 (bad) to 5 (excellent), grouped into four areas (dexterity, visuo-spatial ability, operative flow and judgement), each subdivided into three technical components.
次要结局
- Errors during surgery(Assessed during surgery and registered directly after the surgery on the same day as the surgery)
- Surgeon's learning curve with the procedure in practise(Assessed through study completion, an average of 1 year)
- Patient's convenience during the surgery(Assessed directly postoperatively,on the same day as the surgery)
- Arm circumference over time(At baseline, 3, 6, and 12 months following LVA)
- Surgeon's satisfaction with the procedure(Assessed directly after surgery, on the same day as the surgery)
- Duration of the surgery(Assessed once and registered directly after the surgery)
- Arm volume over time(At baseline, 3, 6, and 12 months following LVA)
- Perioperative complications(Assessed during surgery and postoperatively, in case any occur)
- Patient's symptoms over time(At baseline, 3, 6 and 12 months following LVA)