comparisone of 5day, 3month, 6month and 1year prognosis of treatment of patient with malignant intracranial hypertension by decompressive craniotomy and hinge cranioplasty in Sina hospital in 2016-2017
comparison of outcome and complication of hinge cranioplsty and decompressive craniectomy in treatment of malignant intracranial hypertension and replacing this method of surgery (hinge cranioplasty) in treatment of malignant intracranial hypertension if outcome is better and complication is less.
Design
Randomized parallel group trial with blinded outcome assessment. randomization was done with sealed envelop method and composed 14 patient underwent hinge cranioplasty and 14 underwent decompressive craniectomy.
Settings and conduct
surgery is done on neurosurgery operation room of Sina hospital with blindness of surgeon about type cranioplasty or craniectomy and ICU care and management by blindness of nurse.
Participants/Inclusion and exclusion criteria
patient who underwent cerebral decompression:
1.patient with diagnosis of ischemic cerebrovascular accident and intracranial hypertension above 20cmHg despite maximum medical therapy or sign of brain herniation or decrease level of consciousnesses or focal neurological deficit.
2.patient with intracerebral hematoma above 30 cc and 5mm midline shift and decrease level of consciousness and focal neurological deficit
3.patient with traumatic subdural hematoma or intracerebral hematoma need operation for hematoma evacuation.
Intervention groups
patient with diagnosis of malignant intracranial hypertension due to internal carotid territory infarction , traumatic and non traumatic intracranial hematoma , subdural hematoma underwent cerebral decompresion with one these two method: decompressive craniotomy or hinge cranioplasty
comparisone of 5day, 3month, 6month and 1year prognosis of treatment of patient with malignant intracranial hypertension by decompressive craniotomy and hinge cranioplasty in Sina hospital in 2016-2017
Public title
hinge cranioplasty in treatment of malignant intracranial hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with diagnosis of malignant intracranial hypertension indicate cerebral decompression despite medical management
hemorrhagic and ischemic infarct of internal carotid territory
patient with diagnosis of unilateral internal carotid territory intracranial hematoma that indicate surgery without coincidence hematoma E.g Subdural hematoma
patient with traumatic unilateral temporal, parietal, frontal subdural hematoma or combination of them in one side even with same side contusion(not need evacuation) with intracranial pressure above 20cmHg or protrusion of brain parenchym out of site of craniectomy
Exclusion criteria:
pregnant women
patient died during first day after operation
occipital or cerebellar infarction (non internal carotid territory)
patient with history of psychosis
concomitant lesion e.g Brain tumor
concomitant cerebrovascular lesion e.g aneurysm
patient without follow up
patient with history of neurological disorder that cause neurological deficit
multiple cerebrovascular accident or multiple hemorrhagic lesion
history of previous cerebrovascular accident
bilateral cerebrovascular accident or bilateral hemorrhage
concomitant subdural hematoma and intracranial hemorrhage
traumatic posterior fossa hematoma
intraventricular hemorrhage
patient with subdural hematoma and glascow coma scale 3 without brain palsation
depressed fracture and patient with dis-usable bone flap
patient who underwent temporal lobectomy
traumatic injury to thoracic, abdomen, pelvic and their content that need intervention
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
patient who indicate cerebral decompression (as mentioned before) with sealed envelop method and announce the surgeon who is blind at the end of surgery the method of surgery termination(Hinge cranioplasty or decompressive craniectomy). patient post operation underwent ICU care under supervision of director of study and nursing who are blind of type of surgery.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Imam Khomeini St Hasan abad Sq SINA hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2018-01-15, 1396/10/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.4230
Health conditions studied
1
Description of health condition studied
patient with malignant intracranial hypertention
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
short term and long term evaluation of effect of hinge cranioplasty in decreasing intracranial pressure
Timepoint
5 day - 3 month - 6 month - 1year
Method of measurement
ICP monitoring with subdural catheter in first 5 day - evaluating the patient with Modified Rankin scale and Glasgow Outcome scale in 3 and 6 month and 1year
Secondary outcomes
1
Description
long term quality of life and complication
Timepoint
3 month - 6 month -1 year
Method of measurement
Modified Rankin scale and Glasgow Outcome scale
Intervention groups
1
Description
Intervention group: patient who had malignant intracranial hypertention and not releived with medical managment randomely devided to two group . On hinge cranioplasty patient underwent question mark incision and after dissection of skin flap the pericraniom will dissected and used for duraplasty after the removal of the frontotemporoparietal bone flap. After duraplasty bone flap will attach loosely with one miniplate to frontal bone and the temporal and parietal miniplate just attached to the bone flap.
Category
N/A
2
Description
Control group: On decompressive craniectomy patient underwent question mark incision and after dissection of skin flap the pericraniom will dissected and used for duraplasty after the removal of the frontotemporoparietal bone flap and it will be inserted on the upper quadrant of the abdomen on the same side of craniectomy. patient underwent cranioplasty after 6 months.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Mohammad Mostafa Harifi
Street address
Emam khomeini St , Hasan abad Sq , Sina hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1459
Email
sgmortazavi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
mohammadali sahraeian
Street address
SINA HOSPITAL, HASAN ABAD SQURE, IMAM KHOMEINI AVENUE
City
tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 0000
Fax
+98 21 6634 8553
Email
SGMORTAZAVI@SINA.TUMS.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mostafa Harifi
Position
Resident of neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Emam Khomeini St, Hasan abad Sq, Sina hospital
City
tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1459
Email
harifimm@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Abolghasem Mortazavi
Position
Associate Professor of neurosurgery
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Imam khomeini St, Hasan abad Sq, Sina hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1459
Email
sgmortazavi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad mostafa Harifi
Position
Resident of neurosurgery
Latest degree
Medical doctor
Other areas of specialty/work
Neurosurgery
Street address
Imam khomeini St, Hasan Abad Sq, Sina hospital
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6312 1459
Email
harifimm@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all data can be published after disguised the patient
When the data will become available and for how long
2 Month after publishing the result
To whom data/document is available
data is available for researcher , physician , therapeutic and educational and scientific center
Under which criteria data/document could be used
for increasing treatment efficacy
From where data/document is obtainable
Mohammad Mostafa Harifi
sgmortazavi@sina.tums.ac.ir
00989168289382
Tehran hasan abad Sq emam khomeini st sina hospital
What processes are involved for a request to access data/document