[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604046":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":36,"locations":45,"responsibleParty":371,"collaborators":25,"id":373,"slug":374,"hasResults":375,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":375,"sex":381,"minAge":382,"maxAge":383,"enrollmentInfo":384,"targetDuration":25,"studyType":387,"phases":388,"briefSummary":390,"conditions":391,"keywords":393,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":407},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Neuroendoscope-assisted hematoma drainage","EXPERIMENTAL","Under the guidance of a visualized neuroendoscope, the hematoma is thoroughly irrigated and evacuated.",[13],"Procedure: Endoscope-assisted hematoma drainage",{"label":15,"type":6,"description":16,"interventionNames":17},"Burr hole hematoma drainage","The hematoma cavity is irrigated intraoperatively until the drainage fluid becomes clear.",[18],"Procedure: Burr hole hematoma drainage",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9],null,{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"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.",[15],[30,33],{"name":31,"affiliation":5,"role":32},"Guoyi Gao, MD","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":5,"role":35},"Liang Wu, MD","STUDY_DIRECTOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":25,"email":40},"CONTACT","18301674233","jasewl@sina.com",{"name":42,"role":38,"phone":43,"phoneExt":25,"email":44},"Yu Yan, MB","13701141637","2710575494@qq.com",[46,68,82,96,109,122,136,149,159,169,182,196,209,223,236,249,263,276,289,302,316,329,343,357],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Beijing Tiantan Hospital, Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100070","China","CN",{"type":55,"coordinates":56},"Point",[57,58],116.39723,39.9075,{"lat":58,"lon":57},[61,65,66],{"name":31,"role":38,"phone":62,"phoneExt":63,"email":64},"13801874393","+86","gao3@sina.com",{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"name":34,"role":67,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"facility":69,"status":48,"city":70,"state":71,"zip":72,"country":52,"countryCode":53,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"First Affiliated Hospital of Xiamen University","Xiamen","Fujian","361003",{"type":55,"coordinates":74},[75,76],118.08187,24.47979,{"lat":76,"lon":75},[79],{"name":80,"role":38,"phone":81,"phoneExt":25,"email":25},"Zhanxiang Wang, M.D.","13666082686",{"facility":83,"status":48,"city":84,"state":85,"zip":86,"country":52,"countryCode":53,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Jiangmen Central 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M.D.","13878401206",{"facility":183,"status":48,"city":184,"state":185,"zip":186,"country":52,"countryCode":53,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"Hebei University of Engineering Affiliated Hospital","Handan","Hebei","056002",{"type":55,"coordinates":188},[189,190],114.48764,36.60999,{"lat":190,"lon":189},[193],{"name":194,"role":38,"phone":195,"phoneExt":25,"email":25},"Xiushan Li, M.D.","13592602885",{"facility":197,"status":48,"city":198,"state":185,"zip":199,"country":52,"countryCode":53,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Xingtai Central Hospital","Xingtai","054099",{"type":55,"coordinates":201},[202,203],114.49272,37.06217,{"lat":203,"lon":202},[206],{"name":207,"role":38,"phone":208,"phoneExt":25,"email":25},"Jinmin Hao, M.D.","13932995289",{"facility":210,"status":48,"city":211,"state":212,"zip":213,"country":52,"countryCode":53,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Changde First People's 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Hospital","Pu'er","Yunnan","665099",{"type":55,"coordinates":349},[350,351],100.97481,22.78863,{"lat":351,"lon":350},[354],{"name":355,"role":38,"phone":356,"phoneExt":25,"email":25},"Xingchang Li, M.D.","18087915959",{"facility":358,"status":48,"city":359,"state":360,"zip":361,"country":52,"countryCode":53,"cosmosGeoPoint":362,"geoPoint":366,"contacts":367},"First Affiliated Hospital of Wenzhou Medical University","Wenzhou","Zhejiang","325000",{"type":55,"coordinates":363},[364,365],120.66682,27.99942,{"lat":365,"lon":364},[368],{"name":369,"role":38,"phone":370,"phoneExt":25,"email":25},"Zhipeng Su, M.D.","18324239321",{"type":372,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100604046","neuroendoscopy-assisted-drainage-versus-burr-hole-drainage-for-chronic-subdural-hematoma-100604046",false,"NCT07144423","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","URANUS","Inclusion Criteria:\n\n1. Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH.\n2. CSDH verified on cranial computed tomography or magnetic resonance imaging.\n3. Written informed consent from patients or their next of kin according to the patient's cognitive status.\n\nExclusion Criteria:\n\n1. No clinical symptoms correlating with chronic subdural hematoma.\n2. Lack of mass effect and midline shift \\\u003C 5 mm on the radiological image, or no need surgery judged clinically by neurosurgeons.\n3. Previous surgery for CSDH during the past 6 months.\n4. Previous intracranial surgery for any other neurological disorder.\n5. Poor medication conditions or the presence of severe comorbidities so that surgery cannot be tolerated, or follow-up cannot be completed.\n6. 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 \\\u003C 100×109\u002FL).\n7. Postoperative compliance is suspected to be insufficient for 3-month follow-up visit.\n8. Reproductive-age women without verified negative pregnancy testing.\n9. Participating in another research.","ALL","18 Years","90 Years",{"count":385,"type":386},770,"ESTIMATED","INTERVENTIONAL",[389],"NA","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.",[392],"Chronic Subdural Hematoma",[392,394,395,396,397],"Neuroendoscopy-assisted Drainage","Burr Hole Drainage","Recurrence Rate","Neurological Outcome","2026-02-05",{"date":400,"type":401},"2026-02-09","ACTUAL",{"date":403,"type":401},"2025-11-19",{"date":405,"type":386},"2027-12-31",{"name":5,"class":6},24]