Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma
NCT ID: NCT07144423
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
770 participants
INTERVENTIONAL
2025-08-31
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Neuroendoscope-assisted hematoma drainage
Under the guidance of a visualized neuroendoscope, the hematoma is thoroughly irrigated and evacuated.
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.
Burr hole hematoma drainage
The hematoma cavity is irrigated intraoperatively until the drainage fluid becomes clear.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
90 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Principal Investigators
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Guoyi Gao, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Liang Wu, MD
Role: STUDY_DIRECTOR
Beijing Tiantan Hospital
Locations
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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
Liuzhou, 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
the First People'S Hospital of Yibin
Yibin, Sichuan, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Pu'er People's Hospital
Pu'er, Yunnan, China
First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Zhanxiang Wang, M.D.
Role: primary
Jiyong Gu, M.D.
Role: primary
Ke Xu, M.D.
Role: primary
Zheng Liu, M.D.
Role: primary
Quan Liu, M.D.
Role: primary
Chunhai Tang, M.D.
Role: primary
Feng Wei, M.D.
Role: primary
Yi Huang, M.D.
Role: primary
Zhongyong Deng, M.D.
Role: primary
Xiushan Li, M.D.
Role: primary
Jinmin Hao, M.D.
Role: primary
Jiangli Wen, M.D.
Role: primary
Changhua Xiang, M.D.
Role: primary
Jian Zhou, M.D.
Role: primary
Tiezhu Guo, M.D.
Role: primary
Honggang Ren, M.D.
Role: primary
Xiaohui Yao, M.D.
Role: primary
Haikang Zhao, M.D.
Role: primary
Zhiyong Gou, M.D.
Role: primary
Hua Peng, M.D.
Role: primary
Yongxin Wang, M.D.
Role: primary
Xingchang Li, M.D.
Role: primary
Zhipeng Su, M.D.
Role: primary
References
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Asghar M, Adhiyaman V, Greenway MW, Bhowmick BK, Bates A. Chronic subdural haematoma in the elderly--a North Wales experience. J R Soc Med. 2002 Jun;95(6):290-2. doi: 10.1258/jrsm.95.6.290.
Bakheet MF, Pearce LA, Hart RG. Effect of addition of clopidogrel to aspirin on subdural hematoma: meta-analysis of randomized clinical trials. Int J Stroke. 2015 Jun;10(4):501-5. doi: 10.1111/ijs.12419. Epub 2014 Dec 3.
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Other Identifiers
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HX-A-2025027
Identifier Type: -
Identifier Source: org_study_id
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