[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649069":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":87,"collaborators":91,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":26,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":26,"enrollmentInfo":104,"targetDuration":26,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":118,"whyStopped":26,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"The Second Hospital of Anhui Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Frontal (Anterior) Burr Hole Puncture Drainage (twist-drill drainage)","EXPERIMENTAL","The puncture point is selected within the anterior coverage region of the hematoma area-typically within the frontal bone region anterior to the coronal suture-avoiding the frontal sinus, obvious cortical veins, and key functional areas. The exact location is determined based on preoperative CT 3D reconstruction, with principles of safe entry into the subdural hematoma space and an appropriate catheter direction toward the main hematoma cavity\u002Fcompartment.",[13],"Procedure: Frontal-region puncture drainage",{"label":15,"type":16,"description":17,"interventionNames":18},"Parietal Eminence Burr Hole Puncture Group(twist-drill drainage)","ACTIVE_COMPARATOR","The puncture point is selected at the vertex (crown vertex) region within the hematoma area. The exact location is determined based on preoperative CT 3D reconstruction, with principles of safe entry into the subdural hematoma space and an appropriate catheter direction toward the main hematoma cavity\u002Fcompartment.",[19],"Procedure: Parietal Eminence region puncture drainage",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Frontal-region puncture drainage","Patients will undergo burr-hole puncture drainage at the frontal region (frontal puncture) for chronic subdural hematoma (cSDH).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Parietal Eminence region puncture drainage","Patients will undergo burr-hole puncture drainage at the Parietal Eminence\u002Ftubercle region (vertex puncture) for cSDH.",[15],[32],{"name":33,"affiliation":5,"role":34},"qi li, MD","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"jie shen, MD","CONTACT","+8613515515154","efy126405@fy.ahmu.edu.cn",[42,58,73],{"facility":43,"status":26,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The Second Affiliated Hospital of Anhui Medical University","Hefei","Anhui","230601","China","CN",{"type":50,"coordinates":51},"Point",[52,53],117.28083,31.86389,{"lat":53,"lon":52},[56],{"name":57,"role":38,"phone":39,"phoneExt":26,"email":26},"Jie Shen, MD",{"facility":59,"status":26,"city":60,"state":61,"zip":62,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Huai'an First People's Hospital","Huai'an","Jiangsu","223300",{"type":50,"coordinates":64},[65,66],119.01917,33.58861,{"lat":66,"lon":65},[69],{"name":70,"role":38,"phone":71,"phoneExt":26,"email":72},"Quan Chen, Dr","86+13852346565","13852346565@163.com",{"facility":74,"status":26,"city":75,"state":61,"zip":76,"country":47,"countryCode":48,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Yangzhou University Affiliated Hospital","Yangzhou","225009",{"type":50,"coordinates":78},[79,80],119.43583,32.39722,{"lat":80,"lon":79},[83],{"name":84,"role":38,"phone":85,"phoneExt":26,"email":86},"Chun Xiao Duan, Dr","86+13852703561","doctor_duan@163.com",{"type":88,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Jie Shen","Principal Investigator",[92,94],{"name":93,"class":6},"Yangzhou University",{"name":59,"class":6},"100649069","frontal-vs-parietal-eminence-drainage-for-chronic-subdural-hematoma-100649069",false,"NCT07731620","Frontal vs Parietal Eminence Drainage for Chronic Subdural Hematoma","Frontal Versus Parietal Eminence Twist-Drill Drainage for Chronic Subdural Hematoma","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Unilateral chronic subdural hematoma (cSDH) or subacute-to-chronic subdural hematoma, confirmed by CT or MRI.\n3. Presence of clinical symptoms attributable to cSDH, such as headache, limb weakness, gait disturbance, cognitive decline, speech disturbance, seizure, or impaired consciousness.\n4. Radiological indication for surgery, defined as one of the following:\n\n   Maximum hematoma thickness ≥ 10 mm, and\u002For Midline shift ≥ 5 mm, or Even if these thresholds are not met, clinically significant symptoms requiring surgery as judged by the treating neurosurgeon.\n5. Plan to undergo twist-drill puncture drainage with a closed drainage system.\n6. Written informed consent signed by the participant or their legally authorized representative.\n\nExclusion Criteria:\n\n1. Bilateral cSDH requiring simultaneous bilateral surgery.\n2. Acute subdural hematoma, or a condition where the hematoma is predominantly composed of an acute hemorrhagic component.\n3. Markedly septated, organized, or calcified hematoma in which minicraniotomy or craniotomy is required preoperatively.\n4. Previous surgery on the ipsilateral side for cSDH.\n5. Concomitant intracranial conditions requiring specific treatment, including but not limited to: intracranial tumor, brain abscess, vascular malformation, or ruptured aneurysm.\n6. Severe coagulation disorder that cannot be corrected before surgery.\n7. Life expectancy \\\u003C 6 months.\n8. Pregnancy.\n9. Any condition that, in the judgment of the investigator, makes the patient inappropriate for participation in the study.","ALL","18 Years",{"count":105,"type":106},440,"ESTIMATED","INTERVENTIONAL",[109],"NA","This clinical trial aims to find out whether the puncture site used during minimally invasive surgery with twist-drill puncture and closed-system drainage affects the treatment of chronic subdural hematoma (cSDH).\n\nThe target population is adults with a unilateral chronic subdural hematoma who need surgical drainage based on their symptoms and imaging findings (CT\u002FMRI).\n\nThe main questions this study is designed to answer are:\n\n* Does the puncture site affect the risk of same-side cSDH recurrence requiring reoperation within 3 months\n* Does the puncture site affect recovery and key clinical outcomes after surgery (including functional status and postoperative recovery measures)\n\nThere are two groups, researchers will compare:\n\n* Group A: patients receiving puncture at the frontal region vs.\n* Group B: patients receiving puncture near the parietal eminence to determine whether one puncture site leads to better outcomes than the other.\n\nParticipants will:\n\n* undergo a surgical procedure where, based on random assignment, the puncture site is either frontal or near the parietal eminence;\n* receive closed-system drainage after a twist-drill puncture;\n* complete follow-up assessments at discharge, 30 days, 3 months after surgery, which will include symptom review and imaging (CT) evaluations to check hematoma changes and recurrence;\n* have safety monitoring throughout the study period to record any complications or adverse events.",[112],"Chronic Subdural Hematoma",[114,115,116,117],"chronic subdural hematoma","twist drill","parietal eminence puncture","frontal puncture","NOT_YET_RECRUITING","2026-07-25",{"date":121,"type":122},"2026-07-28","ACTUAL",{"date":124,"type":106},"2027-01",{"date":126,"type":106},"2029-06",{"name":5,"class":6},3]