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.
Overview
- Phase
- Phase 2
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Cerebrospinal fluid leakage
Overview
Brief Summary
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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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Infected dermoid tumors
- •Intramedullary abscess
- •Myelomeningocele surgery and related reoperation
- •Meningocele
- •Presence of hydrocephalus
Arms & Interventions
Acetazolamide
administration of Acetazolamide for 10 days following the surgery
Intervention: Acetazolamide (Drug)
Prone positioning
Positioning the patient following surgery for 10 days
Intervention: prone positioning (Other)
Acetazolamide and Prone positioning
applying both Acetazolamide and prone positioning
Intervention: Acetazolamide+ prone positioning (Other)
Outcomes
Primary Outcomes
Cerebrospinal fluid leakage
Time Frame: 1month
leakage of CSF during 1 months following surgery
wound dehiscence
Time Frame: 1 month
dehiscence of the surgical wound during the first month following surgery
Cerebrospinal fluid collection
Time Frame: 1 month
collection of the CSF beneath the skin during 1 month following the surgery
Secondary Outcomes
No secondary outcomes reported