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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

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

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

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

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

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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