Multicenter Clinical Study Evaluating the Functional Prognosis and Quality of Life at Least 2 Years in Patients Treated With Decompressive Craniectomy for Malignant Sylvian Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- To assess the quality of life for long-term patients victims of malignant sylvian ischemic stroke who received decompressive craniectomy.
研究概览
简要总结
The objective of this protocol is to evaluate the quality of life and functional disability in the long term (2 years after craniectomy) in subject's victims of malignant Sylvien stroke who received a decompressive craniotomy in the acute phase. Patients who have given their consent to be evaluated at least two years after their stroke and their operation in a single visit by clinical examination and procurement of standardized scales. Will be measured the quality of life through scale SIS3.0, residual disability by the Rankin scale. The quality of life of the carer will be assessed through scales and Zarit carer version of SIS3.0. The existence of predictive parameters of long-term evolution will be searched in determining the existence of a correlation between demographic data and baseline characteristics of the stroke on and the evolution of the quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age> = 18 years
- •Having presented an ischemic stroke involving the sylvian area
- •Having received decompressive craniectomy in acute ischemic stroke
- •Time between stroke and the inclusion of at least 24 months
- •Signed informed consent
- •Patient affiliated to a social security system
排除标准
- •Patients with a Rankin score before stroke than or equal to 3
- •Stroke in multiple territories (contralateral carotid and / or vertebrobasilar) associated with stroke in the acute phase describing which in the opinion of the investigator significantly influence the long-term functional prognosis
- •Cognitive deterioration or severe aphasia making it impossible to fill out questionnaires
- •Major under curators
结局指标
主要结局
To assess the quality of life for long-term patients victims of malignant sylvian ischemic stroke who received decompressive craniectomy.
时间窗: at least two years
次要结局
- To assess the rate of recovery work(at least two years)
- To evaluate the quality of life in the physical and psychosocial domains(at least two years)
- To evaluate the evolution of functional disability(At 3 months, 12 months and 24 months.)
- To evaluate the life satisfaction(at least two years)
- To determine the prognostic factors that influence the level of handicap and quality of life in the long term.(at least two years)
- To evaluate the quality of life and level of long-term care accompanying persons caring for the near a victim of malignant sylvian ischemic stroke who received a decompressive craniotomy.(at least two years)
- To evaluate the retrospective review of patients achieving craniectomy(at least two years)