Robot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- operative bleeding
研究概览
简要总结
With significant advances in diagnostic imaging and systemic therapies for oncologic disease, spinal metastasis with neurological dysfunction and mechanical instability has become an indication for surgery. Even if traditional-open surgery was palliative, the treatment of spinal metastasis also carried significant surgical morbidity. Those high morbidity and complication rates may influence the quality of patients with a limited life expectancy. Invasion-controlled surgery was utilized with Robot-assisted surgery approach against symptomatic spinal metastasis.
Increasing interest in the potential for improved consistency, complication reduction, and decreased length of hospitalization through robot utilization is evident from the rapid growth of publications seen in recent years.
So, the investigators wish to evaluate the advantages of Robot-assisted Invasion-controlled Surgery compared with traditional-open surgery spinal surgery in patients with metastatic spinal cord compression.
详细描述
Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery. A prospective Clinical Trial
Purpose To investigate the effect of Robot-assisted Invasion-controlled Surgery compared with traditional-open surgery in the treatment of patients with metastatic spinalcord compression.
Hypotheses The group of patient's receiving robot-assisted invasion-controlled surgery will have better improvement in quality after surgery compared to the group that will receive traditional open surgery. The robot-assisted invasion-controlled surgery group will have reduction in per-operative bleeding and less wound complications compered to the group of patients receiving open or traditional surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of spinal metastasis (previously confirmed diagnosis of lung cancer, liver cancer, prostate cancer, breast cancer, kidney cancer, digestive tract cancer, imaging indicated the presence of metastatic lesions in the spine)
- •Patients with symptoms of spinal instability or nerve compression (SINS score of spinal instability ≥7, spinal nerve compression according to spinal cord injury Classification, grade A-D)
- •Metastases are located in the thoracic and/or lumbar vertebrae
- •The patient's expected survival was longer than 6 months
- •The subjects or their legal representatives were able to understand the study purpose, demonstrate adequate compliance with the study protocol, and sign informed consent
排除标准
- •He had previously operated on the same site
- •Spontaneous multiple compression fractures of the spine;
- •There is malformed osteitis (Paget's bone disease), osteomalacia, or other metabolic bone disease;
- •here were developmental vertebral malformations or vertebral body and pedicle dysplasia in the spinal segment to be treated by surgery
- •Presence of heart, lung, liver or kidney failure or other serious diseases (such as osteomyelitis, systemic infection, severe hemorrhagic disease, active disseminated intravascular coagulation, serious cardiovascular disease or myocardial infarction within 6 months prior to enrollment, cerebral infarction within 6 months prior to enrollment, severe psychiatric history)
- •Pregnant or lactating women
- •Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment
结局指标
主要结局
operative bleeding
时间窗: Intraoperative
It is amount of blood lost during surgery, which is checked by the anesthesiologist and the surgical nurse.
次要结局
- Intraoperative fluoroscopy dose(Intraoperative)
- operation time(Intraoperative)
- Intraoperative transfusion volume(Intraoperative)
- VAS Scores(less than 2 years)
- myoglobin(less than 2 years)
- Frankel Scores(less than 2 years)
- Creatine kinase levels(less than 2 years)
- ODI scores(less than 2 years)
- Complications(less than 2 years)
- Survival time(less than 2 years)
- QOL Scores(less than 2 years)
- resuming time of daily life(less than 2 years)
研究者
Wei Xu
Clinical Professor
Shanghai Changzheng Hospital