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| ID | Type | Description | Link |
|---|---|---|---|
| 21843 | Other Identifier | Tehran University of Medical Sciences |
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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:
Period of study: Autumn 2012 to the end of winter of 2015
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetazolamide | Experimental | administration of Acetazolamide for 10 days following the surgery |
|
| Control | No Intervention | control group without any intervention | |
| Prone positioning | Experimental | Positioning the patient following surgery for 10 days |
|
| Acetazolamide and Prone positioning | Experimental | applying both Acetazolamide and prone positioning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetazolamide | Drug | Acetazolamide administration for 10 days adjust dosage with weight of the patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebrospinal fluid leakage | leakage of CSF during 1 months following surgery | 1month |
| Cerebrospinal fluid collection | collection of the CSF beneath the skin during 1 month following the surgery | 1 month |
| wound dehiscence | dehiscence of the surgical wound during the first month following surgery | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Farideh Nejat, MD | Contact | +98 912 1494064 | nejat@tums.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| Farideh Nejat, MD | Tehran University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children'S Medical Center | Recruiting | Tehran | Tehran Province | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21721886 | Background | 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. | |
| 26824595 | Derived | 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. |
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| prone positioning | Other | prone positioning the patient for 10 days following the surgery |
|
| Acetazolamide+ prone positioning | Other | administration of acetazolamide and position the patient for 10 days following the surgery |
|
| ID | Term |
|---|---|
| C537030 | Lipomyelomeningocele |
| D009436 | Neural Tube Defects |
| D016136 | Spina Bifida Occulta |
| D009369 | Neoplasms |
| D065634 | Cerebrospinal Fluid Leak |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016135 | Spinal Dysraphism |
| D009461 | Neurologic Manifestations |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| D016684 | Prone Position |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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