Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery. A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Bleeding
研究概览
简要总结
The investigators wish to evaluate the effect of minimal access spinal surgery compared to traditional open surgery spinal surgery in patients with metastatic spinal cord compression.
Minimal access surgery has been shown to bee less damaging for the tissue compared to traditional open surgery and also cause fewer wound complications, the investigators expect the above could have impact in a vulnerable patient group like patients with metastatic spinal cord compression.
详细描述
Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery. A Randomized Clinical Trial
Purpose To investigate the effect of minimal access spine surgery (MASS) compared with conventional open surgery in the treatment of patients with metastatic spinalcord compression (MSCC).
Hypotheses The group of patient's receiving MASS will have better improvement in quality after surgery compared to the group that will receive traditional open surgery. The MASS patient group will have reduction in per-operative bleeding and less wound complications needing surgical revision compered to the group of patients receiving open or traditional surgery.
Primary outcome Perioperative bleeding.
Secondary outcomes Quality of life and incidence of revision surgery.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metastatic spinal cord compression with a metastasis from Th5-L3 Tokuhashi above 4
排除标准
- •Need for radical treatment and not only palliative
- •Need for surgical stabilization in a region lower then L3
研究组 & 干预措施
open surgery
One arm receives open surgery. In our department open surgery is considered as the standard procedure since all spine surgeons are preforming this operation.
干预措施: open surgery (Procedure)
Minimal access surgery
We compare to well-known types of surgery for metastatic spinal cord compression. The other arm receive open surgery. In our department minimal access surgery is considered as a standard procedure but it is not preformed by all spine surgeons.
干预措施: Minimal access surgery (Procedure)
结局指标
主要结局
Bleeding
时间窗: intraoperative
The investigators compare the bleeding for each treatment modality during the operation.
次要结局
- Health related quality of life measured with questionnaire EQ-5D and QLQ-C30(before intervention and six months follow up)
研究者
Søren Schmidt Morgen
Medical doctor
Rigshospitalet, Denmark