Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.
BMC Neurol. 2012 Jun 7;12:34. doi: 10.1186/1471-2377-12-34.
Spontaneous intracerebral hemorrhage is a disease with high morbidity, high disability rate, high mortality, and high economic burden. Whether patients can benefit from surgical evacuation of hematomas is still controversial, especially for those with moderate-volume hematomas in the basal ganglia. This study is designed to compare the efficacy of endoscopic surgery and conservative treatment for the moderate-volume hematoma in spontaneous basal ganglia hemorrhage.
Patients meet the criteria will be randomized into the endoscopic surgery group (endoscopic surgery for hematoma evacuation and the best medical treatment) or the conservative treatment group (the best medical treatment). Patients will be followed up at 1, 3, and 6 months after initial treatment. The primary outcomes include the Extended Glasgow Outcome Scale and the Modified Rankin Scale. The secondary outcomes consist of the National Institutes of Health Stroke Scale and the mortality. The Barthel Index(BI) will also be evaluated. The sample size is 100 patients.
The ECMOH trial is a randomized controlled trial designed to evaluate if endoscopic surgery is better than conservative treatment for patients with moderate-volume hematomas in the basal ganglia.
Chinese Clinical Trial Registry: ChiCTR-TRC-11001614(http://www.chictr.org/en/proj/show.aspx?proj=1618).
自发性脑出血是一种发病率高、致残率高、死亡率高、经济负担重的疾病。手术清除血肿是否能使患者获益仍存在争议，特别是对于基底节区中等量血肿的患者。本研究旨在比较内镜手术与保守治疗对自发性基底节区脑出血中等量血肿的疗效。
符合标准的患者将被随机分为内镜手术组（内镜手术清除血肿和最佳药物治疗）或保守治疗组（最佳药物治疗）。患者将在初始治疗后 1、3 和 6 个月进行随访。主要结局包括扩展格拉斯哥结局量表和改良 Rankin 量表。次要结局包括国立卫生研究院卒中量表和死亡率。还将评估巴氏指数（BI）。样本量为 100 例患者。
ECMOH 试验是一项随机对照试验，旨在评估内镜手术是否优于保守治疗对基底节区中等量血肿患者的疗效。
中国临床试验注册中心：ChiCTR-TRC-11001614（http://www.chictr.org/en/proj/show.aspx?proj=1618）。
