A prospective multicenter cohort study was designed to compare the differences in complications with YL-1 Needle Puncture versus Bulr-hole Craniotomy (BHC) with postoperative Exhaustive Drainage strategy for patients with Chronic Subdural Hematoma.
Chronic subdural haematoma (CSDH) is a common condition in neurosurgery. It is generally considered to be a closed exudate formed by blood or blood degradation products between the dura mater and the arachnoid membrane. Its local occupying effect will compress the neighbouring brain tissues, leading to varying degrees of neurological dysfunction. In severe cases, it can lead to cerebral hernia and endanger the patient's life. Currently, the most commonly used surgical method for the treatment of chronic subdural haematoma is BHC, but many studies have found that various complications may occur after BHC. With the rapid development of neurosurgical microtechnology, Twist Drill Craniotomy (TDC) was proposed. YL-1 puncture needle technique, as a modified solution of TDC, has a short surgical time and is less traumatic to patients. In the treatment of chronic subdural haematomas, investigator's team has adopted the strategy of postoperative instillation of urokinase and adequate drainage of the haematoma. Based on this, this study intends to conduct a multicentre prospective observational cohort study of the above two treatment in order to scientifically and rigorously derive the optimal clinical treatment strategy for chronic subdural haematoma.
Study Type
OBSERVATIONAL
Enrollment
460
According to the preoperative CT results, drilling and drainage was performed at the thickest level of the hematoma; during the operation, the hematoma cavity was adequately flushed with saline and a drainage tube was left in the hematoma cavity; after the operation, the hematoma cavity was flushed with urokinase, and the drainage tube was removed after adequate drainage.
Based on preoperative CT, the thickest level of the hematoma was selected and localized. During the operation, an electric drilling needle was used to rapidly break through the skull and dura to enter the cavity of the subdural hematoma, and the puncture needle was fixed to the skull to drain the subdural hematoma. After the operation, the hematoma cavity was flushed with urokinase, and the drainage tube was removed after adequate drainage.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGComplication rates
To compare the difference in overall complication rates between the two groups of CSDH patients treated with YL-1 perforator needles and drilled drainage at 3 months postoperatively.
Time frame: From operation up to 3 months postoperatively
Recurrence rate
To compare the difference in recurrence rate at 3 months postoperatively between the two groups;
Time frame: From operation up to 3 months postoperatively
Mortality rate
To compare the difference in mortality rate at 3 months postoperatively between the two groups;
Time frame: From operation up to 3 months postoperatively
Change of Modified Rankin Scale (MRS) between groups from baseline to 3 months after operation
Modified Rankin Scale ranges from score 1 to 6, and higher scores mean a worse clinical outcome, where score 1 indicates normal daily functionality and score 6 indicates death.
Time frame: At baseline and at 3 months after operation
Quality of life assessment (EQ-5D-5L)
A standardized instrument, EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire, will be used as a generic measure of health related quality of life. The questionnaire contains 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension rates across five levels, including 'No problems-Slight problems-Moderate problems-Severe problems-Unable to'postoperatively between the two groups.
Time frame: At baseline and at 3 months after operation
Change of Markwalder Grading Scale between groups from baseline to 3 months after operation
Markwalder Grading Scale ranges from grade 0 to 4, and higher scores mean a worse neurological outcome, where grade 0 indicates normal neurological function and grade 4 indicates coma.
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Time frame: At baseline and at 3 months after operation
Hospitalization costs
To compare the difference in hospitalization costs between the two groups.
Time frame: At baseline.
Length of hospitalization
To compare the difference in length of hospitalization between the two groups;
Time frame: At baseline.