Evaluation and comparison of the results of acute subdural hematoma evacuation by two methods of multidural stabs versus open dural flap

Comparison of the results of acute cerebral subdural hematoma drainage using two methods: multidural slit and duraplasty.

A controlled, double-blind, randomized, phase 3 clinical trial with parallel groups on 94 patients. The randomization will be performed using a block method using software called Sealed Envelope.

This study will be conducted on 94 patients with subdural hematoma who are candidates for surgery at Vali Asr Hospital in Arak. This study will be conducted in a double-blind manner and patients, clinical caregivers, and outcome assessors will be blinded to the study groups.

Inclusion criteria: Age 18 to 60 years, acute subdural hematoma requiring surgery without other associated bleeding. Exclusion criteria: underlying coagulation disorder, brain tumor

Intervention group 1: 47 patients will undergo surgery using the Durmerflap technique, in which a decompression craniectomy is performed by removing parts of the frontal, temporal, parietal, and occipital bones, resulting in 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 hemostasis is achieved. (Complete duraplasty is performed with the temporalis or pericranium fascia). Intervention group 2: 47 patients 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. Normal saline is continuously used to flush the dura of blood and clots, and a soft silastic catheter is inserted to remove clots stuck to the surface of the brain.

Assessment of level of consciousness, Glasgow Outcome Scale

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.

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).