This study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma
This study is a multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment to evaluate the effects of body posture on hematoma recurrence. Patients will be assigned in a 1:1 ratio to body posture group(upper body lay flat, lower body elevate 30° or 20-30cm, head turn to affected side) or control group(supine position) randomly. After operation, patients will be required to keep respective body posture at sleep time for 3 months. Instead of body posture, patients will receive routine treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
830
IHT therapy requires CSDH patients to raise their lower limbs 30° higher over the horizontal level of their head.For patients with unilateral CSDH, the head should be tilted towards the hematoma affected side and opposite side lying should be avoided as much as possible. For patients with bilateral CSDH, there is no need for the head lateralization.To avoid food reflux and aspiration pneumonia, IHT therapy was strictly prohibited within 2 hours after each meal
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGsubdural hematoma recurrence rate
Recurrence is defined as maximum thickness of subdural hematoma more than 10mm, and patients have subdural hematoma related symptoms without head injury.
Time frame: within 90±10 days post-surgery
change in modified Rankin Scale(mRS) compared to baseline
The mRS is a clinician-reported measure of global disability,ranging from 0 to 6, with higher scores indicating more severe disability
Time frame: 90days and 1year post-surgery
change in EQ-5D-5L score compared to baseline
The 5-level EQ-5D version (EQ-5D-5L) is a standardised measure of health status
Time frame: 90days and 1year post-surgery
differences between two group in comorbidities
comparison of comorbidities rate of two group
Time frame: 90days post-surgery
differences between two group in complications
comparison of complications rate of two group
Time frame: 90day post-surgery
subdural hematoma recurrence rate
comparison of recurrence rate of two group
Time frame: 1year post-surgery
all cause recurrence rate
comparison of recurrence rate of two group caused by whatever the reasons
Time frame: 90days and 1year post-surgery
differences between two group in recurrence time
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comparison of recurrence time of two group
Time frame: within 90days and 1year post-surgery