Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence
Primary Purpose
Fibrolipoma of Filum Terminale, Lipomyelomeningocele, Split Cord Malformation
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Acetazolamide
prone positioning
Acetazolamide+ prone positioning
Sponsored by
About this trial
This is an interventional prevention trial for Fibrolipoma of Filum Terminale focused on measuring Acetazolamide administration, prone positioning, Cerebrospinal fluid leakage, Cerebrospinal fluid collection, wound dehiscence
Eligibility Criteria
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
Sites / Locations
- Children'S Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
Experimental
Arm Label
Acetazolamide
Control
Prone positioning
Acetazolamide and Prone positioning
Arm Description
administration of Acetazolamide for 10 days following the surgery
control group without any intervention
Positioning the patient following surgery for 10 days
applying both Acetazolamide and prone positioning
Outcomes
Primary Outcome Measures
Cerebrospinal fluid leakage
leakage of CSF during 1 months following surgery
Cerebrospinal fluid collection
collection of the CSF beneath the skin during 1 month following the surgery
wound dehiscence
dehiscence of the surgical wound during the first month following surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT01867268
First Posted
May 29, 2013
Last Updated
April 17, 2015
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01867268
Brief Title
Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrolipoma of Filum Terminale, Lipomyelomeningocele, Split Cord Malformation, Dermal Sinus, Tethered Cord Syndrome, Tumor
Keywords
Acetazolamide administration, prone positioning, Cerebrospinal fluid leakage, Cerebrospinal fluid collection, wound dehiscence
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acetazolamide
Arm Type
Experimental
Arm Description
administration of Acetazolamide for 10 days following the surgery
Arm Title
Control
Arm Type
No Intervention
Arm Description
control group without any intervention
Arm Title
Prone positioning
Arm Type
Experimental
Arm Description
Positioning the patient following surgery for 10 days
Arm Title
Acetazolamide and Prone positioning
Arm Type
Experimental
Arm Description
applying both Acetazolamide and prone positioning
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Other Intervention Name(s)
Diamox
Intervention Description
Acetazolamide administration for 10 days adjust dosage with weight of the patient
Intervention Type
Other
Intervention Name(s)
prone positioning
Intervention Description
prone positioning the patient for 10 days following the surgery
Intervention Type
Other
Intervention Name(s)
Acetazolamide+ prone positioning
Intervention Description
administration of acetazolamide and position the patient for 10 days following the surgery
Primary Outcome Measure Information:
Title
Cerebrospinal fluid leakage
Description
leakage of CSF during 1 months following surgery
Time Frame
1month
Title
Cerebrospinal fluid collection
Description
collection of the CSF beneath the skin during 1 month following the surgery
Time Frame
1 month
Title
wound dehiscence
Description
dehiscence of the surgical wound during the first month following surgery
Time Frame
1 month
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farideh Nejat, MD
Phone
+98 912 1494064
Email
nejat@tums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farideh Nejat, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Children'S Medical Center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
+98 21 61479
First Name & Middle Initial & Last Name & Degree
Shima Shahjouei, Student
12. IPD Sharing Statement
Citations:
PubMed Identifier
21721886
Citation
Chern JJ, Tubbs RS, Patel AJ, Gordon AS, Bandt SK, Smyth MD, Jea A, Oakes WJ. Preventing cerebrospinal fluid leak following transection of a tight filum terminale. J Neurosurg Pediatr. 2011 Jul;8(1):35-8. doi: 10.3171/2011.4.PEDS10502.
Results Reference
background
PubMed Identifier
26824595
Citation
Shahjouei S, Hanaei S, Habibi Z, Hoseini M, Ansari S, Nejat F. Randomized clinical trial of acetazolamide administration and/or prone positioning in mitigating wound complications following untethering surgeries. J Neurosurg Pediatr. 2016 Jun;17(6):659-66. doi: 10.3171/2015.8.PEDS15393. Epub 2016 Jan 29.
Results Reference
derived
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Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence
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