NCT01930617已完成不适用
Irrigation of Chronic Subdural Hematomas - is More Better? A Population Based Study Between Different Treatment Policies
St. Olavs Hospital3 个研究点 分布在 2 个国家目标入组 1,258 人开始时间: 2014年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,258
- 试验地点
- 3
- 主要终点
- reoperations
研究概览
简要总结
There are numerous reported ways to treat chronic subdural hematomas (CSDH) and practice is still differing considerably between departments. Except for a recent randomized controlled trial (RCT) that found that postoperative subdural drainage was better than no drain, there is no higher level evidence. Another recent RCT did not replicate these findings, but the study was severely underpowered.
Aim of this population based study is to compare clinical results (reoperation rates, complications, perioperative death, and survival) between neurosurgical departments treating CSDH with different treatment policies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at St.Olav University Hospital
- •All patients treated with evacuation of primary chronic subdural hematoma(CSDH) from 2005 through 2010 at University Hospital North Norway
- •All patients treated with evacuation of primary CSDH from 2006 through 2010 at Karolinska University Hospital (not 2005 due to practical reasons since major changes occurred in electronic surgery protocols 2005).
排除标准
- •Chronic subdural hematoma in arachnoid cyst(s)
- •Previous CSDH surgery
- •External hydrocephalus (hydrocephalus with cerebrospinal fluid (CSF) in the subdural space rather than in the ventricles)
- •CSDH due to previous intracranial surgery (within 6 months).
结局指标
主要结局
reoperations
时间窗: 1 year
Number of reoperations (X/N, %) between centers
次要结局
- continuous irrigation versus other drainage(1 year)
- perioperative death(30 days)
- survival(3 years)
- surgical complications(30 days)
研究者
研究点 (3)
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