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IRCT20180515039678N1 IRCT 2018-11-21 Tehran University of Medical Sciences hinge cranioplasty in treatment of malignant intracranial hypertension 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 2018-01-15 anticipated 28 Complete https://irct.ir/trial/32148 interventional Randomization: Not randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 3 patient with malignant intracranial hypertention. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: all data can be published after disguised the patient When: 2 Month after publishing the result To whom: data is available for researcher , physician , therapeutic and educational and scientific center Conditions: for increasing treatment efficacy Where to obtain: Mohammad Mostafa Harifi sgmortazavi@sina.tums.ac.ir 00989168289382 Tehran hasan abad Sq emam khomeini st sina hospital How to obtain: contacing with authors Comments:
public Mohammad Mostafa Harifi
Emam Khomeini St, Hasan abad Sq, Sina hospital
tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1459 harifimm@gmail.com Tehran University of Medical Sciences scientific Seyed Abolghasem Mortazavi
Imam khomeini St, Hasan abad Sq, Sina hospital
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6312 1459 sgmortazavi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 80 years Both 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 N/A Treatment - Surgery 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. 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. 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. Long term quality of life and complication. Timepoint: 3 month - 6 month -1 year. Method of measurement: Modified Rankin scale and Glasgow Outcome scale. Tehran University of Medical Sciences Approved 2018-01-15 Ethics committee of Tehran University of Medical Sciences Imam Khomeini St Hasan abad Sq SINA hospital Tehran Tehran Iran (Islamic Republic of)