YL-1 Needle Puncture vs BHC With Postoperative Exhaustive Drainage for CSDH

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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YL-1 Needle Puncture Versus Burr-hole Craniotomy With Postoperative Exhaustive Drainage for Chronic Subdural Hematoma: a Multicenter Prospective Cohort Study

Conditions
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Chronic Subdural Hematoma

Intervention / Treatment
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* Procedure: Burr Hole Craniostomy and Postoperative Exhaustive Drainage Strategy
* Procedure: YL-1 puncture needle and Postoperative Exhaustive Drainage Strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, male or female, 18 years ≤ age ≤ 90 years; Preoperative neurological dysfunction, such as headache and dizziness, nausea and vomiting, limb numbness or weakness, unsteady walking, limb twitching, confusion, aphasia, slow response, memory loss, etc; A definite diagnosis of chronic subdural hematoma by CT or MRI; Signed informed consent. Exclusion Criteria: No symptoms before surgery and no obvious impact on oneself's normal life; Lack of mass effect, less than 0.5 cm of midline structure shift, and no need surgery judged clinically by neurosurgeons; Previous surgery for chronic subdural hematoma during the past 6 months; Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before Existing poor medication condition or severe comorbidity so that surgery cannot be tolerated or follow-up cannot be completed Combination of major systemic diseases that are expected to interfere with study implementation and follow-up observations; Definite coagulation abnormalities with a high risk of bleeding (presence of one of the following three: prolongation of the prothrombin time PT or the activated partial thromboplastin time APTT by more than 10 seconds, an international normalized ratio INR greater than 3.0, and an absolute platelet value of less than 100 × 109/L); Postoperative cooperation is suspected to be insufficient for follow-up for 6 months; Reproductive-age women without verified negative pregnancy testing; Participating in other research

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BHC group<br>Patients with CSDH recruited from the neurosurgery departments of 6 medical centers in China who had clinically significant symptoms confirmed by computed tomography or magnetic resonance imaging and ultimately treated with Bulr-hole Craniotomy. | Procedure: Burr Hole Craniostomy and Postoperative Exhaustive Drainage Strategy<br>* 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.<br>|
| YL-1 Needle Puncture group<br>Patients with CSDH recruited from the neurosurgery departments of 6 medical centers in China who had clinically significant symptoms confirmed by computed tomography or magnetic resonance imaging and ultimately treated with YL-1 needle puncture. | Procedure: YL-1 puncture needle and Postoperative Exhaustive Drainage Strategy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication 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. | From operation up to 3 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate | To compare the difference in recurrence rate at 3 months postoperatively between the two groups; | From operation up to 3 months postoperatively | 
| Mortality rate | To compare the difference in mortality rate at 3 months postoperatively between the two groups; | 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. | 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. | 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. | At baseline and at 3 months after operation | 
| Hospitalization costs | To compare the difference in hospitalization costs between the two groups. | At baseline. | 
| Length of hospitalization | To compare the difference in length of hospitalization between the two groups; | At baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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YL-1 Needle Drainage, Burr Hole Craniostomy, Exhaustive drainage strategy, Chronic Subdural Hematoma