Tumor Clinical Trial
Official title:
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.
- 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.
- Sample size: 144
- intervention groups:
- 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
- Period of study: Autumn 2012 to the end of winter of 2015
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention
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