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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.


Phase 2
N/A
18 Years
Open (Enrolling)
Both
Tethered Cord Syndrome, Split Cord Malformation, Lipoma of Spinal Cord

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Trial Information

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.


The purpose of this study is to evaluate the effect of Acetazolamide adminestration and
prone positioning following lumbosacral spinal surgery in preventing cerebro spinal fluid
leakage and collection and wound dehissence in children admited to Children Medical Center
of Tehran since Autumn 2012 to the end of winter of 2014.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+ 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+ prone positioning and the patient is considered as the
failure of the protocol.


Inclusion Criteria:



- dethetering surgery

- resection of lipoma

- split cord malformation management

- having any other disease with similar management technique

Exclusion Criteria:

- myelomeningocele

- lipomyelomeningocele

- meningocele

- occupying masses in spine such as

- dermoid cysts

- norenteric cysts

- those who underwern reoperation

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Cerebrospinal fluid leakage

Outcome Description:

leakage of CSF during 1 months following surgery

Outcome Time Frame:

1month

Safety Issue:

No

Principal Investigator

Farideh Nejat, MD

Investigator Role:

Study Director

Investigator Affiliation:

Tehran University of Medical Sciences

Authority:

Iran: Ethics Committee

Study ID:

2137

NCT ID:

NCT01867268

Start Date:

October 2012

Completion Date:

March 2014

Related Keywords:

  • Tethered Cord Syndrome
  • Split Cord Malformation
  • Lipoma of Spinal Cord
  • Acetazolamide administration
  • prone positioning
  • Cerebrospinal fluid leakage
  • Cerebrospinal fluid collection
  • wound dehiscence
  • Congenital Abnormalities
  • Cerebrospinal Fluid Rhinorrhea
  • Intracranial Hypotension
  • Lipoma
  • Retinitis Pigmentosa
  • Neural Tube Defects
  • Spinal Cord Neoplasms

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