Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06363474 |
| Other study ID # |
UHS 5532 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2024 |
| Est. completion date |
May 1, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
University of Health Sciences Lahore |
| Contact |
Dr. Mustapha Shesh, MSNeurosugery |
| Phone |
03166951158 |
| Email |
sheshmustapha[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 p≤0.05 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
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 0.05 will be
considered significant.
