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Minimally Invasive Surgery in Treating Patients With Spinal Tumors

2015年6月3日 更新者:City of Hope Medical Center

Comparison of Minimally Invasive Approaches of Spine Tumor Surgery

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

研究概览

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

介入性

注册 (实际的)

7

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Duarte、California、美国、91010
        • City of Hope Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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:
  • 生活质量评估
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:
  • 生活质量评估
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
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

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Rahul Jandial, MD、City of Hope Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年5月1日

初级完成 (实际的)

2014年6月1日

研究完成 (实际的)

2014年6月1日

研究注册日期

首次提交

2011年3月1日

首先提交符合 QC 标准的

2011年3月2日

首次发布 (估计)

2011年3月4日

研究记录更新

最后更新发布 (估计)

2015年6月8日

上次提交的符合 QC 标准的更新

2015年6月3日

最后验证

2015年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 10115 (DAIDS-ES)
  • NCI-2011-00231 (注册表标识符:CTRP (Clinical Trial Reporting Program))

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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