Evaluating the Effect of Acetazolamide Administration and Prone Positioning Following Lumbosacral Spinal Surgery in Preventing Cerebro Spinal Fluid Leakage and Collection and Wound Dehiscence in Children.
试验速览
- 阶段
- 2 期
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Cerebrospinal fluid leakage
研究概览
简要总结
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Purpose of study : to determine the preventive effect of acetazolamide administration, prone positioning, and the combination of both following the neurosurgical interventions in lumbosacral region for cerebrospinal fluid (CSF) leak, CSF collection and wound dehiscence.
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Sample size: 144
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intervention groups:
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Group A: Acetazolamide administration for 10 days
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Group B: prone positioning for 10 days
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Group C: Acetazolamide administration and prone positioning for 10 days
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Group D: no intervention
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Period of study: Autumn 2012 to the end of winter of 2015
详细描述
The purpose of this study is to evaluate the effect of Acetazolamide administration and prone positioning following lumbosacral spinal surgery in preventing cerebro-spinal fluid leakage and collection and wound dehissence in children admitted to Children Medical Center of Tehran since Autumn 2012 to the end of winter of 2015.The study is run under 4 categories of intervention:
- Group A: Acetazolamide administration for 10 days
- Group B: prone positioning for 10 days
- Group C: Acetazolamide administration and prone positioning for 10 days
- Group D: no intervention All patients are randomly assigned to these groups and when the patients faced with any of these complications, the protocol changes to Acetazolamide administration and prone positioning and the patient is considered as the failure of the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Untethering surgery for primary tethered cord caused by thick filum
- •Lipomyelomeningocele
- •Split cord malformation management
- •Untethering surgery in uncomplicated Dermal sinus
- •Tumors needing intradural management in lumbosacral region
- •Having any other disease with similar management technique
排除标准
- •Infected dermoid tumors
- •Intramedullary abscess
- •Myelomeningocele surgery and related reoperation
- •Meningocele
- •Presence of hydrocephalus
研究组 & 干预措施
Acetazolamide
administration of Acetazolamide for 10 days following the surgery
干预措施: Acetazolamide (Drug)
Prone positioning
Positioning the patient following surgery for 10 days
干预措施: prone positioning (Other)
Acetazolamide and Prone positioning
applying both Acetazolamide and prone positioning
干预措施: Acetazolamide+ prone positioning (Other)
结局指标
主要结局
Cerebrospinal fluid leakage
时间窗: 1month
leakage of CSF during 1 months following surgery
wound dehiscence
时间窗: 1 month
dehiscence of the surgical wound during the first month following surgery
Cerebrospinal fluid collection
时间窗: 1 month
collection of the CSF beneath the skin during 1 month following the surgery
次要结局
未报告次要终点