Fibrolipoma of Filum TerminalePhase 2NCT01867268
Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence
A Phase 2 study testing Acetazolamide, prone positioning and Acetazolamide+ prone positioning in people with Fibrolipoma of Filum Terminale and Lipomyelomeningocele, run by Tehran University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Fibrolipoma of Filum Terminale, Lipomyelomeningocele, Split Cord Malformation
- What is being tested?
- Acetazolamide, prone positioning and Acetazolamide+ prone positioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteIran
- Study dates
- Oct 2012to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Infected dermoid tumors
- Intramedullary abscess
- Myelomeningocele surgery and related reoperation
- Meningocele
- Presence of hydrocephalus
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Children'S Medical Center
Tehran, Tehran Province
+98 21 61479
Shima Shahjouei, Student
About this study
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.
- 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
Read the 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.
- Conditions
- Fibrolipoma of Filum Terminale, Lipomyelomeningocele, Split Cord Malformation, Dermal Sinus, Tethered Cord Syndrome, Tumor
- Being tested
- Acetazolamide, prone positioning, Acetazolamide+ prone positioning
- Keywords
- Acetazolamide administration, prone positioning, Cerebrospinal fluid leakage, Cerebrospinal fluid collection, wound dehiscence
- Medical subject headings
- Lipomyelomeningocele, Neural Tube Defects, Spina Bifida Occulta, Neoplasms, Cerebrospinal Fluid Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Also called Diamox
Acetazolamide administration for 10 days adjust dosage with weight of the patient
prone positioningOther
prone positioning the patient for 10 days following the surgery
Acetazolamide+ prone positioningOther
administration of acetazolamide and position the patient for 10 days following the surgery
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Experimental | administration of Acetazolamide for 10 days following the surgery Receives: Drug: Acetazolamide |
| Control | No intervention | control group without any intervention |
| Prone positioning | Experimental | Positioning the patient following surgery for 10 days Receives: Other: prone positioning |
| Acetazolamide and Prone positioning | Experimental | applying both Acetazolamide and prone positioning Receives: Other: Acetazolamide+ prone positioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrospinal fluid leakage
leakage of CSF during 1 months following surgery
Measured: 1month
Cerebrospinal fluid collection
collection of the CSF beneath the skin during 1 month following the surgery
Measured: 1 month
wound dehiscence
dehiscence of the surgical wound during the first month following surgery
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionApr 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fibrolipoma of Filum TerminaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farideh Nejat, MD, Study director, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867268
- Sponsor's protocol ID
- 2137
- Other IDs
- 21843
- Status last verified
- Apr 2015
- First submitted
- 29 May 2013
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21721886Shahjouei 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.
PubMed 26824595
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01867268
- Acronym / sponsor ID
- 2137
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 3 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Experimental | Drug: Acetazolamideadministration of Acetazolamide for 10 days following the surgery |
| Control | No intervention | –control group without any intervention |
| Prone positioning | Experimental | Other: prone positioningPositioning the patient following surgery for 10 days |
| Acetazolamide and Prone positioning | Experimental | Other: Acetazolamide+ prone positioningapplying both Acetazolamide and prone positioning |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Infected dermoid tumors
- Intramedullary abscess
- Myelomeningocele surgery and related reoperation
- Meningocele
- Presence of hydrocephalus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetazolamideAlso: DiamoxAcetazolamide administration for 10 days adjust dosage with weight of the patient | Drug | Acetazolamide |
| prone positioningprone positioning the patient for 10 days following the surgery | Other | Prone positioning |
| Acetazolamide+ prone positioningadministration of acetazolamide and position the patient for 10 days following the surgery | Other | Acetazolamide and Prone positioning |
Primary outcome
Cerebrospinal fluid leakage
Time frame: 1month
leakage of CSF during 1 months following surgery
Cerebrospinal fluid collection
Time frame: 1 month
collection of the CSF beneath the skin during 1 month following the surgery
wound dehiscence
Time frame: 1 month
dehiscence of the surgical wound during the first month following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2015.
- Background: PubMed 21721886Chern 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.
- Derived from this study: PubMed 26824595Shahjouei 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farideh Nejat, MD study director
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetazolamide, prone positioning and Acetazolamide+ prone positioning in people with Fibrolipoma of Filum Terminale and Lipomyelomeningocele, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farideh Nejat, MD (+98 912 1494064, nejat@tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrospinal fluid leakage (time frame: 1month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01867268, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2015.