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

Phase 2

• Conditions: Tumor; Tethered Cord Syndrome; Lipomyelomeningocele; Dermal Sinus; Fibrolipoma of Filum Terminale; Split Cord Malformation
• Interventions: Other: prone positioning; Drug: Acetazolamide; Other: Acetazolamide+ prone positioning

• Registration Number: NCT01867268
• Lead Sponsor: Tehran University of Medical Sciences

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-05-29
• Study First Submitted QC: 2013-05-31
• Study First Posted: 2013-06-03
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Last Update Submitted: 2015-04-17
• Last Update Posted: 2015-04-21
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Prone positioning	prone positioning	Positioning the patient following surgery for 10 days
Acetazolamide	Acetazolamide	administration of Acetazolamide for 10 days following the surgery
Acetazolamide and Prone positioning	Acetazolamide+ prone positioning	applying both Acetazolamide and prone positioning

Primary Outcome Measures

Name	Time	Method
Cerebrospinal fluid leakage	1month	leakage of CSF during 1 months following surgery
wound dehiscence	1 month	dehiscence of the surgical wound during the first month following surgery
Cerebrospinal fluid collection	1 month	collection of the CSF beneath the skin during 1 month following the surgery

Trial Locations

Locations (1)

Children'S Medical Center; 🇮🇷 Tehran, Iran, Islamic Republic of