Comparison of Minimally Invasive Approaches of Spine Tumor Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Complication rate
研究概览
简要总结
This randomized clinical trial studies minimally invasive surgery in treating patients with spinal tumors. Posterior spinal tumor resection and anterior and posterior spinal tumor resection are less invasive types of surgery for spinal tumors and may have fewer side effects and improve recovery
详细描述
PRIMARY OBJECTIVES:
I. Length of operation (operating room [OR] time). II. Estimated blood loss (EBL). III. Complication rate. IV. Neurological preservation.
SECONDARY OBJECTIVES:
I. Motor strength and sensory level (neurological outcome). II. Bladder and bowel function. III. Post-operative pain. IV. Hospital length of stay (recovery time). V. Arthrodesis.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a diagnosis of primary, secondary or metastatic spine tumor and be undergoing any posterior spinal fusion with or without anterior fusion anywhere from occiput to sacrum
- •Greater than 3 month life expectancy
- •Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
- •All subjects must have the ability to understand and the willingness to sign a written informed consent
排除标准
- •Patients who are not surgical candidates for spine tumor removal, determined by the surgical team
- •Patients who have undergone previous spine surgery for tumor removal will be excluded
- •Patients with renal cell carcinoma
- •As there is an emphasis on blood loss and length of surgery, the critical variable for homogeneity is the vascularity of the tumor; hypervascular spine tumors are regarded by surgeons as amongst the most challenging of cases; by far the three most common hypervascular metastatic tumors are those arising from renal cell carcinoma, thyroid carcinoma and melanoma; these pathologies are usually regarded as a distinct subset for this reason in the majority of studies; because we rarely encounter the later two pathologies in our practice, we chose to include only the former; however, to further homogenize our study population we will exclude all three of the known hypervascular metastatic spine tumors
- •Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
结局指标
主要结局
Complication rate
时间窗: Day 0
Neurological preservation
时间窗: Post operation day 90
Length of operation (OR time)
时间窗: Day 0
Will be comparing means with the Wilcoxon test.
Estimated blood loss (EBL); in milliliters (ml)
时间窗: Day 0
Will be comparing means with the Wilcoxon test.
次要结局
- Length of stay(Less than 7 days)
- Evaluation of arthrodesis(Post-op day 1, 28, and 90)
- Pain symptoms(Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90)
- Assessment of neurologic function using the ASIA (American Spinal Injury Association) Impairment Scale(Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90)