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The purpose of the present study is to compare the effectiveness and safety of two surgery evacuation methods (endoscopic surgery and suboccipital craniotomy) in the treatment of acute spontaneous cerebellar hemorrhage (SCH). A multi-center randomized control trial will be conducted. Patients with an initial GCS score of 5-14 will be screened and enrolled in the first 24 hours after SCH.
Spontaneous cerebellar hemorrhage (SCH) accounts for about 9-10% of all ICH cases, with a mortality rate of 20-50%. Suboccipital craniotomy was the traditional surgery method in the treatment of SCH. Minimally invasive techniques, including endoscopic evacuation and minimally invasive catheter (MIC) evacuation, have been used for the treatment of SCH) in recent years. However, credible evidence is still needed to validate the effects of these techniques. The treatment effect of endoscopic evacuation and MIC evacuation was compared in our previous study, results showed that the endoscopic evacuation significantly decreased the 6-month mortality of SCH patients. Thus endoscopic evacuation might be a safer and more effective option in the treatment of SCH. Therefore, in the current study, a multi-center randomized control trial will be conducted to compare the effectiveness and safety of endoscopic surgery and suboccipital craniotomy in the treatment of acute SCH. A multi-center randomized control trial will be conducted. Patients with an initial GCS score of 5-14 will be screened according to the selecting criteria. The enrolled patients will undertake the surgery within the first 24 hours after SCH. The primary outcome is the 30-day mortality rate. And the secondary outcomes including the 6-month mRS, the incidence of adverse events within 30-day, the hematoma clearance rate, the residual hematoma volume on postoperative day 1/3/7, and the perihematoma edema volume on postoperative day 1/3/7.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic surgery | Experimental | Endoscopic surgery group |
|
| Suboccipital craniotomy surgery | Active Comparator | Suboccipital craniotomy surgery group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic surgery | Procedure | The endoscopic surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | The mortality rate in each group at 30 days after SCH. | Within 30 days after SCH |
| Measure | Description | Time Frame |
|---|---|---|
| mRS Score | The mortality rate in each group at 6 months after SCH. | Within 6 months after SCH |
| Adverse Events | The Incidence of adverse events within 30 days after SCH. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Guo, M.D Ph.D | Contact | 86-18729985168 | 18729985168@163.com | |
| Haixiao Liu, M.D Ph.D | Contact | 86-15929315407 | 56761311@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Qu, M.D Ph.D | Tang-Du Hospital | Study Chair |
| Wei Guo, M.D Ph.D | Tang-Du Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tandu Hospital, Fourth Military Medical University | Recruiting | Xi'an | Shaanxi | 710038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32623579 | Background | Li L, Liu H, Luo J, Tan Z, Gao J, Wang P, Jing W, Fan R, Zhang X, Guo H, Bai H, Cui W, Wu X, Qu Y, Guo W. Comparison of Long-Term Outcomes of Endoscopic and Minimally Invasive Catheter Evacuation for the Treatment of Spontaneous Cerebellar Hemorrhage. Transl Stroke Res. 2021 Feb;12(1):57-64. doi: 10.1007/s12975-020-00827-8. Epub 2020 Jul 4. | |
| 7039001 |
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| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Not provided
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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The grouping was blind to the investigators performing the follow-up and the statistical analysis
| Suboccipital craniotomy surgery | Procedure | The suboccipital craniotomy surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH. |
|
| Within 30 days after SCH |
| Residual Hematoma Volume | The residual hematoma volume on postoperative day 1, day 3 and day 7. | Within 7 days after SCH |
| Perihematoma Edema Volume | The perihematoma edema volume on postoperative day 1, day 3 and day 7. | Within 7 days after SCH |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 | Surgical Procedures, Operative |