Minimally Invasive Surgery in Treating Patients With Spinal Tumors
Comparison of Minimally Invasive Approaches of Spine Tumor Surgery
研究概览
地位
详细说明
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.
ARM I: Patients undergo posterior spinal tumor resection on day 0.
ARM II: Patients undergo anterior and posterior spinal tumor resection on day 0.
After completion of study treatment, patients are followed up for 6 months.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
California
-
Duarte、California、美国、91010
- City of Hope Medical Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Arm I (posterior spinal tumor resection)
Patients undergo posterior spinal tumor resection on day 0.
|
辅助研究
其他名称:
Undergo posterior spinal tumor resection
Undergo anterior and posterior spinal tumor resection
|
|
实验性的:Arm II (anterior and posterior spinal tumor resection)
Patients undergo anterior and posterior tumor resection on day 0.
|
辅助研究
其他名称:
Undergo posterior spinal tumor resection
Undergo anterior and posterior spinal tumor resection
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Estimated blood loss (EBL); in milliliters (ml)
大体时间:Day 0
|
Will be comparing means with the Wilcoxon test.
|
Day 0
|
|
Length of operation (OR time)
大体时间:Day 0
|
Will be comparing means with the Wilcoxon test.
|
Day 0
|
|
Complication rate
大体时间:Day 0
|
Day 0
|
|
|
Neurological preservation
大体时间:Post operation day 90
|
Post operation day 90
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Length of stay
大体时间:Less than 7 days
|
Less than 7 days
|
|
|
Pain symptoms
大体时间:Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
|
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
大体时间:Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
|
This is an assessment of sensory and motor functions based upon the ASIA Impairment Scale
|
Pre-operation, post-op day 3, discharge, post-op days 7, 28, 60, and 90
|
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Evaluation of arthrodesis
大体时间:Post-op day 1, 28, and 90
|
Plain x-ray films and CT scans are used to determine the success of arthrodesis (spinal fusion in this case) which is the artificial induction of joint ossification between two bones via surgery.
This is done to relieve intractable pain in a joint which cannot be managed by pain medication.
|
Post-op day 1, 28, and 90
|
合作者和调查者
调查人员
- 首席研究员:Rahul Jandial, MD、City of Hope Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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