Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01867268
• Other study ID #: 2137
• Secondary ID: 21843
• Status: Recruiting
• Phase: Phase 2
• First received: May 29, 2013
• Last updated: April 17, 2015
• Start date: October 2012
• Est. completion date: September 2015

Study information

• Verified date: April 2015
• Source: Tehran University of Medical Sciences
• Contact: Farideh Nejat, MD
• Phone: +98 912 1494064
• Email: nejat[@]tums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: September 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dermal Sinus
• Fibrolipoma of Filum Terminale
• Lipomyelomeningocele
• Neural Tube Defects
• Split Cord Malformation
• Tethered Cord Syndrome
• Tumor

Intervention

Drug:
• Acetazolamide
Acetazolamide administration for 10 days adjust dosage with weight of the patient

Other:
• prone positioning
prone positioning the patient for 10 days following the surgery
• Acetazolamide+ prone positioning
administration of acetazolamide and position the patient for 10 days following the surgery

Locations

Country	Name	City	State
Iran, Islamic Republic of	Children`S Medical Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebrospinal fluid leakage	leakage of CSF during 1 months following surgery	1month	No
Primary	Cerebrospinal fluid collection	collection of the CSF beneath the skin during 1 month following the surgery	1 month	No
Primary	wound dehiscence	dehiscence of the surgical wound during the first month following surgery	1 month	No