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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
190
The endoscopic surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.
The suboccipital craniotomy surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.
Tandu Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
RECRUITINGMortality Rate
The mortality rate in each group at 30 days after SCH.
Time frame: Within 30 days after SCH
mRS Score
The mortality rate in each group at 6 months after SCH.
Time frame: Within 6 months after SCH
Adverse Events
The Incidence of adverse events within 30 days after SCH.
Time frame: Within 30 days after SCH
Residual Hematoma Volume
The residual hematoma volume on postoperative day 1, day 3 and day 7.
Time frame: Within 7 days after SCH
Perihematoma Edema Volume
The perihematoma edema volume on postoperative day 1, day 3 and day 7.
Time frame: Within 7 days after SCH
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.