Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363474
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-09
Brief Title:
Cisternostomy Vs Decompressive Craniectomy for Severe Traumatic Brain Injury
Sponsor:
University of Health Sciences Lahore
Organization:
University of Health Sciences Lahore
Study Overview
Official Title:
Cisternostomy Vs Decompressive Craniectomy for Severe Traumatic Brain Injury Functional Outcome Comparison Using Glasgow Outcome Scale
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this clinical study is to compare the outcomes of two neurosurgical interventions Cisternostomy and Decompressive Craniectomy DC for the management of severe Traumatic Brain Injury TBI assessed using the Glasgow Outcome Scale GOS Severe TBI presents challenges in managing intracranial pressure ICP and cerebral perfusion often requiring surgical intervention DC involves the removal of a section of the skull to reduce ICP while Cisternostomy a technique rooted in microsurgery aims to alleviate brain edema and lower ICP by creating additional space for cerebrospinal fluid CSF circulation
This prospective study will be conducted at the Department of Neurosurgery Punjab Institute of Neurosciences Lahore Patients meeting inclusion criteria will be randomized into Group A DC and Group B Cisternostomy following brain CT scans Clinical evaluation will include regular follow-ups for 6 months post-surgery recording data on GOS duration of mechanical ventilation ICU and hospital stays Analysis will be performed using SPSS 24 comparing outcomes between groups using Chi-square test and t-test A significance level of p005 will be applied
It is hypothesized that Cisternostomy as an adjunct to traditional TBI management will effectively reduce ICP resulting in improved GOS and reduced complications postoperatively including decreased duration of mechanical ventilation and ICU stay with sustained improvement observed at 6 months
This prospective study will be conducted at the Department of Neurosurgery Punjab Institute of Neurosciences Lahore Patients meeting inclusion criteria will be randomized into Group A DC and Group B Cisternostomy following brain CT scans Clinical evaluation will include regular follow-ups for 6 months post-surgery recording data on GOS duration of mechanical ventilation ICU and hospital stays Analysis will be performed using SPSS 24 comparing outcomes between groups using Chi-square test and t-test A significance level of p005 will be applied
It is hypothesized that Cisternostomy as an adjunct to traditional TBI management will effectively reduce ICP resulting in improved GOS and reduced complications postoperatively including decreased duration of mechanical ventilation and ICU stay with sustained improvement observed at 6 months
Detailed Description:
Traumatic brain injury TBI remains a major public health problem globally Indications for neurosurgical interventions following TBI can be broadly categorised as 1 evacuation of haematoma 2 control of traumatic intracranial pressure ICP 3 elevation of depressed skull 4 repair of skull base fractures with or without dural repair 5 treatment of hydrocephalus and 6 cranial reconstruction Decompressive craniectomy DC is a neurosurgical procedure that involves the removal of a section of the skull bone flap and expansion duraplasty which provides additional space for the swollen brain to expand leading to a reduction in ICP and maintained or improved cerebral perfusion pressure As an adjunct Cisternal opening is a well-embedded microsurgical technique in neurosurgical practice for vascular and skull base pathologies Its application in the context of TBI in combination with insertion of an external drain which stays in place for a few days post-operatively has been termed cisternostomy The objective of this study is to compare the outcome of Cisternostomy and DC for the management of severe TBI in terms of the Glasgow outcome scale GOS For these two groups meeting the inclusion criteria will be divided based on the lottery method after a CT scan of the brain Group A DC and Group B Cisternostomy for severe TBI The rationale of the procedure lies in the recognition of the important contribution of the perivascular Virchow - Robin spaces to CSF circulation In severe TBI increases the inter-cisternal pressure that provokes a shift of fluid from the cisternal compartment to the brain parenchyma Although DC brings the ICP to atmospheric pressure it does not counter react the intracerebral pressure which causes severe brain swelling and herniation DC may further necessitate an additional operation for cranial reconstruction termed as cranioplasty In this situation cisternostomy is useful in reversing this fluid shift alleviating brain edema and thereby lowering ICP A standard ventricular drain will be placed in the cisternal compartment which will further help in controlling the raised ICP This study will be conducted at the Department of Neurosurgery Punjab Institute of Neurosciences Lahore Clinical evaluation of the patient will be done with regular follow-up for 6 months Data of the GOS duration on Ventilator ICU stay and hospital stay along with extended GOS at 6 months will be recorded and analysed It is expected that the cisternostomy technique 3 can be considered as an adjuvant surgical strategy for severe TBI effective in reducing ICP with good GOS and a low rate of complications in the postoperative period following cisternostomy decreased number of days on a ventilator and ICU stay with good GOS at 6 months Performing a cisternostomy demands specific instruments and expertise in skull base and vascular surgery making its widespread use in trauma care centers challenging Data will be collected and analyzed by using the SPSS 24 version Quantitative variables such as age and demographic variables will be described as Mean - SD for both groups Comparison of both groups for the surgical outcome will be done by using the Chi-square test and t-test according to the nature of outcome variables The P-value of equal or less than 005 will be considered significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None