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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
| Huashan Hospital | OTHER |
| Tianjin Medical University General Hospital | OTHER |
| First Affiliated Hospital of Fujian Medical University |
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The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery: a Multi-center Clinical Trial
To evaluate the effect of different surgical approaches on the prognosis of patients with hypertensive intracerebral hemorrhage, hypertensive patients who met the diagnostic criteria of American guidelines for the treatment of adult spontaneous intracerebral hemorrhage (2015) were selected. The time from onset to admission was less than 8 hours. Blood routine examination, liver and kidney function, coagulation system, infectious diseases and other examinations were performed before operation, with emergency surgical indications, They were divided into two groups: transfrontal keyhole approach and transoccipital keyhole approach. Emergency endoscopic hematoma removal was performed. The patients were systematically evaluated and followed up at 1 week, 1 month, 3 months, 6 months and 12 months after operation to observe the improvement of consciousness, GCS score, postoperative rebleeding (appearance, bleeding volume, location, broken into ventricle, etc.), The prognosis was evaluated by ADL score, GCS score, gos score, modified Rankin scale, Mrs scale and ICH Score (GCS, hematoma volume, intraventricular hemorrhage, infratentorial source, patient age, etc.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trans-frontal keyhole approach | Active Comparator | After general anesthesia, the patient was placed in supine position with head frame fixed. A straight or arc incision was made in the hairline of the affected side. The incision was 3cm beside the midline. The length of the incision was about 4cm and the diameter of the bone window was about 2.5cm. According to the preoperative thin-layer CT scan, the dura mater and part of the cerebral cortex were cut, and the endoport and other hard channels were inserted. The incision reached 2 / 3 of the length of the hematoma along the direction parallel to the long axis of the hematoma, During the operation, mini aneurysms were clipped to close the responsible vessels, and hemostatic gauze was applied on the surface of the hematoma cavity. Silica gel external drainage tube was placed in the hematoma cavity. The external drainage tube led out the skin through the subcutaneous tunnel, and the dura was sutured. |
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| Trans-occipital keyhole approach | Active Comparator | After general anesthesia, the patient was placed in prone position with head frame fixed. According to the preoperative thin-layer CT scan, the long axis of hematoma was perpendicular to the ground, and the occipital puncture point was found along the extension line of the long axis of hematoma. Taking the puncture point as the center, a straight or arc incision parallel to the sagittal sinus was taken. The length of the incision was about 4cm, and the diameter of the bone window was about 2.5cm, Endoport and other hard channels were inserted to reach 2 / 3 of the long diameter of the hematoma along the direction parallel to the long axis of the hematoma. Under the neuroendoscope, the hematoma was aspirated or resected in blocks. During the operation, mini aneurysm clamp was used to clamp the responsible vessels, and hemostatic gauze was applied on the surface of the hematoma cavity. Silica gel external drainage tube was placed in the hematoma cavity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery | Procedure | The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission rate | The evaluation criteria of complete remission: more than 85% of intracranial hematoma was cleared, mild brain edema, and the postoperative hospital stay was less than 2 weeks. The evaluation criteria of partial remission: the clearance rate of intracranial hematoma was 60% - 85%, the postoperative brain edema was obvious, and the postoperative hospital stay was less than 4 weeks. | 1 month postoperation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lijun Hou, MD,PhD | Contact | 86 21 81885671 | houlijunsmmu@163.com | |
| Liang Zhao, MD,PhD | Contact | 86 21 81885686 | 15921509289@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lijun Hou, MD,PhD | Shanghai Changzheng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, Shanghai Changzheng Hospital | Shanghai | Shanghai Municipality | 200003 | China |
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| OTHER |
| Peking Union Medical College Hospital | OTHER |
| Second Affiliated Hospital of Soochow University | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
| The General Hospital of Eastern Theater Command | OTHER |
| First Affiliated Hospital of Harbin Medical University | OTHER |
| Shengjing Hospital | OTHER |
| ShuGuang Hospital | OTHER |
| Qianfoshan Hospital | OTHER |
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| Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach | Procedure | Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach |
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| ID | Term |
|---|---|
| D020299 | Intracranial Hemorrhage, Hypertensive |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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