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RECRUITINGINTERVENTIONAL

Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma

Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma: A Multicenter Randomized Controlled Trial, URANUS

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Chronic subdural hematoma (CSDH) is a frequent condition in neurosurgery, leading to fluid accumulation between the meninges, brain compression, neurological dysfunction, and potentially herniation. The efficacy of treatments and their long-term outcomes remain uncertain, with no established standard. Notably, neuroendoscopy-assisted hematoma evacuation, in contrast to burr-hole drainage, enables direct visualization and thorough removal of the hematoma, thereby minimizing residue, lowering recurrence rates, and shortening drainage duration. This study will undertake a multicenter trial to compare these two methods and determine the superior treatment approach for CSDH.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH. 2. CSDH verified on cranial computed tomography or magnetic resonance imaging. 3. Written willing to sign a consent form from patients or their next of kin according to the patient's cognitive status. Who Should NOT Join This Trial: 1. No clinical symptoms correlating with chronic subdural hematoma. 2. Lack of mass effect and midline shift \< 5 mm on the radiological image, or no need surgery judged clinically by neurosurgeons. 3. Previous surgery for CSDH during the past 6 months. 4. Previous intracranial surgery for any other neurological disorder. 5. Poor medication conditions or the presence of severe comorbidities so that surgery cannot be tolerated, or follow-up cannot be completed. 6. Severe coagulopathy or a high risk of life-threatening bleeding (including any one of the following three criteria: prothrombin time or activated partial thromboplastin time prolonged by more than 10 seconds; international normalized ratio \> 3.0; absolute platelet count \< 100×109/L). 7. Postoperative compliance is suspected to be insufficient for 3-month follow-up visit. 8. Reproductive-age women without verified negative pregnancy testing. 9. Participating in another research. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH. 2. CSDH verified on cranial computed tomography or magnetic resonance imaging. 3. Written informed consent from patients or their next of kin according to the patient's cognitive status. Exclusion Criteria: 1. No clinical symptoms correlating with chronic subdural hematoma. 2. Lack of mass effect and midline shift \< 5 mm on the radiological image, or no need surgery judged clinically by neurosurgeons. 3. Previous surgery for CSDH during the past 6 months. 4. Previous intracranial surgery for any other neurological disorder. 5. Poor medication conditions or the presence of severe comorbidities so that surgery cannot be tolerated, or follow-up cannot be completed. 6. Severe coagulopathy or a high risk of life-threatening bleeding (including any one of the following three criteria: prothrombin time or activated partial thromboplastin time prolonged by more than 10 seconds; international normalized ratio \> 3.0; absolute platelet count \< 100×109/L). 7. Postoperative compliance is suspected to be insufficient for 3-month follow-up visit. 8. Reproductive-age women without verified negative pregnancy testing. 9. Participating in another research.

Treatments Being Tested

PROCEDURE

Endoscope-assisted hematoma drainage

The procedure of endoscope-assisted hematoma drainage is performed under local anesthesia with sedation or general anesthesia. During the operation, a single burr hole is drilled at the midpoint of the thickest layer of the hematoma cavity as shown on CT scan. A bone flap measuring 2.0 cm × 2.0 cm is then created using a milling cutter. Under the guidance of a visualized neuroendoscope, the hematoma is thoroughly irrigated and evacuated. A subdural drainage tube is inserted, and postoperatively, continuous subdural drainage of the hematoma is maintained until the drainage ceases naturally or the drainage tube is removed at a maximum of 48 hours postoperatively to terminate the drainage.

PROCEDURE

Burr hole hematoma drainage

The procedure of burr hole drainage is performed under local anesthesia with sedation or general anesthesia. During the operation, a single burr hole is drilled at the midpoint of the thickest layer of the hematoma cavity as indicated by CT scan. A subdural drainage tube is then inserted. The hematoma cavity is irrigated intraoperatively until the drainage fluid becomes clear. Postoperatively, continuous subdural drainage of the hematoma is maintained until the drainage ceases naturally or the drainage tube is removed at a maximum of 48 hours postoperatively to terminate the drainage.

Locations (20)

Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Shantou central hosital
Shantou, Guangdong, China
People's Hospital of Longhua, Shenzhen
Shenzhen, Guangdong, China
Liuzhou worker's Hospital
Liuchow, Guangxi, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Nanning First People's Hospital
Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
Nanning, Guangxi, China
Wuzhou Gongren Hospital
Wuzhou, Guangxi, China
Hebei University of Engineering Affiliated Hospital
Handan, Hebei, China
Xingtai Central Hospital
Xingtai, Hebei, China
Changde First People's Hospital
Changde, Hunan, China
People's Hospital of Xiangxi Prefecture, Hunan Province
Jishou, Hunan, China
Yueyang Central Hospital
Yueyang, Hunan, China
Heji Hospital affiliated with Changzhi Medical College
Changzhi, Shanxi, China
Linfen People's Hospital
Linfen, Shanxi, China
Shanxi Provincial People's Hospital,Shanxi Medical University
Taiyuan, Shanxi, China
The Second Affiliated Hospital of Xi'an Medical University
Xi’an, Shanxi, China
Mianyang 404 Hospital
Mianyang, Sichuan, China