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

Recruiting

• Conditions: Chronic Subdural Hematoma
• Interventions: Procedure: YL-1 puncture needle and Postoperative Exhaustive Drainage Strategy; Procedure: Burr Hole Craniostomy and Postoperative Exhaustive Drainage Strategy

• Registration Number: NCT06072053
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-10-01
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-10
• Status Verified: 2023-12
• Study Start: 2023-12-22
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-27
• Primary Completion: 2025-01-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

1. Adults, male or female, 18 years ≤ age ≤ 90 years;
2. 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;
3. A definite diagnosis of chronic subdural hematoma by CT or MRI;
4. Signed informed consent.

Exclusion Criteria

1. No symptoms before surgery and no obvious impact on oneself's normal life;
2. Lack of mass effect, less than 0.5 cm of midline structure shift, and no need surgery judged clinically by neurosurgeons;
3. Previous surgery for chronic subdural hematoma during the past 6 months;
4. Previous intracranial surgery for any neurological disorders but chronic subdural hematoma before
5. Existing poor medication condition or severe comorbidity so that surgery cannot be tolerated or follow-up cannot be completed
6. Combination of major systemic diseases that are expected to interfere with study implementation and follow-up observations;
7. 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);
8. Postoperative cooperation is suspected to be insufficient for follow-up for 6 months;
9. Reproductive-age women without verified negative pregnancy testing;
10. Participating in other research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
YL-1 Needle Puncture group	YL-1 puncture needle and Postoperative Exhaustive Drainage Strategy	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.
BHC group	Burr Hole Craniostomy and Postoperative Exhaustive Drainage Strategy	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.

Primary Outcome Measures

Name	Time	Method
Complication rates	From operation up to 3 months postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Hospitalization costs	At baseline.	To compare the difference in hospitalization costs between the two groups.
Recurrence rate	From operation up to 3 months postoperatively	To compare the difference in recurrence rate at 3 months postoperatively between the two groups;
Change of Markwalder Grading Scale between groups from baseline to 3 months after operation	At baseline and at 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.
Mortality rate	From operation up to 3 months postoperatively	To compare the difference in mortality rate at 3 months postoperatively between the two groups;
Length of hospitalization	At baseline.	To compare the difference in length of hospitalization between the two groups;
Change of Modified Rankin Scale (MRS) between groups from baseline to 3 months after operation	At baseline and at 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.
Quality of life assessment (EQ-5D-5L)	At baseline and at 3 months after operation	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.

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China