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IRCT20251228068472N1 IRCT 2026-02-14 Arak University of Medical Sciences Comparison of multidural slit and dural flap in the evacuation of acute subdural hematoma of the brain Evaluation and comparison of the results of acute subdural hematoma evacuation by two methods of multidural stabs versus open dural flap 2026-02-14 anticipated 94 Complete https://irct.ir/trial/88907 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To allocate the samples, a block randomization method with blocks of 8 will be used. Thus, using the block random number generation software, a randomization sequence will be generated in proportion to the required sample size for the two groups. Initially, all the cases in which the 2 letters A, B can be arranged together in a block of 8 are generated. Then, a block is randomly selected from the blocks by placing them, and the arrangement pattern in that block will be used to allocate the participants. Then, this block is placed in the main container and another block will be selected again. All of this will be done with a software called Sealed Envelope. Using this method, concealment will also be observed. The concept of concealment is to make the allocation of individuals to groups unpredictable. In fact, the researcher will not be able to predict which group the next person will be placed in, Blinding description: This study will be double-blind, for this purpose, patients and outcome assessors are blinded. Patients who are unaware of the type of surgery due to reduced level of consciousness and the type of technique performed will be unaware of the surgery. On the other hand, the surgery will be performed by a neurosurgeon and the follow-up and evaluation of patients will be performed by the intern responsible for the project. Therefore, the outcome assessor, who is the intern responsible for the project, will be unaware of the patient grouping and will evaluate patients based on the case number and information received from the attending (neurosurgeon). 3 Subdural Hematoma. Intervention 1: Intervention group 1: 94 patients with subdural hematoma will undergo surgery using the Durmer flap technique. In this method, a decompression craniectomy is performed by removing parts of the frontal, temporal, parietal, and occipital bones, resulting in the creation of a large bone flap (diameter > 12 cm). The dura is then opened in a C-shape towards the base of the skull to drain the hematoma and achieve hemostasis. (Complete duraplasty is performed with the temporalis fascia or pericranium). The advantage of this method is that it immediately reduces intracranial pressure. Intervention 2: Intervention group: Intervention group 2: 94 patients with subdural hematoma will undergo surgery using the multidural slit technique. This is a decompression procedure for acute subdural hematoma in the presence of severe cerebral edema and midline shift to preserve the arachnoid tissue, pia, brain tissue, and its vessels by opening the dura. In this surgical procedure, several linear incisions of 5-8 mm in length are made with a No. 11 knife, in horizontal lines, parallel to the vessels, and 2-2.5 cm apart. Caution is that the tip of the knife should not penetrate more than 0.5 to 1.0 mm in depth. Normal saline is continuously used to flush the dura from blood and clots, and a soft silastic catheter is inserted to remove clots stuck on the brain surface. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Samar Kamalifar
Payambar Azam Complex, Sardasht Town
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3505 samarkamalifar@gmail.com Arak University of Medical Sciences scientific Samar Kamalifar
Payambar Azam Complex, Sardasht Town
Arak Iran (Islamic Republic of) 3848176341 +98 86 3417 3505 samarkamalifar@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Age 18 to 60 years Patients with acute subdural hematoma requiring surgery without other associated bleeding 18 years 60 years Both Underlying coagulation disorder Brain tumor S06.5 Traumatic subdural hemorrhage Treatment - Surgery Treatment - Surgery Intervention group 1: 94 patients with subdural hematoma will undergo surgery using the Durmer flap technique. In this method, a decompression craniectomy is performed by removing parts of the frontal, temporal, parietal, and occipital bones, resulting in the creation of a large bone flap (diameter > 12 cm). The dura is then opened in a C-shape towards the base of the skull to drain the hematoma and achieve hemostasis. (Complete duraplasty is performed with the temporalis fascia or pericranium). The advantage of this method is that it immediately reduces intracranial pressure. Intervention group: Intervention group 2: 94 patients with subdural hematoma will undergo surgery using the multidural slit technique. This is a decompression procedure for acute subdural hematoma in the presence of severe cerebral edema and midline shift to preserve the arachnoid tissue, pia, brain tissue, and its vessels by opening the dura. In this surgical procedure, several linear incisions of 5-8 mm in length are made with a No. 11 knife, in horizontal lines, parallel to the vessels, and 2-2.5 cm apart. Caution is that the tip of the knife should not penetrate more than 0.5 to 1.0 mm in depth. Normal saline is continuously used to flush the dura from blood and clots, and a soft silastic catheter is inserted to remove clots stuck on the brain surface. Level of consciousness. Timepoint: Before and after the intervention. Method of measurement: Glasgow Coma Scale. Disease outcome based on Glasgow Outcome Scale. Timepoint: Before and after the intervention. Method of measurement: Glasgow Outcome Scale. Arak University of Medical Sciences Approved 2024-05-19 Ethics committee of Arak University of Medical Sciences Payambar Azam Complex, Sardasht Town Arak Markazi Iran (Islamic Republic of)