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Craniectomy Protocol

2021年9月8日更新者：Nantes University Hospital

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

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.

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

法国
- - Angers、法国
    - CHU Angers
  - Brest、法国
    - CHU de Brest
  - Rennes、法国
    - CH R U Pontchaillou
  - Tours、法国
    - CHU Bretonneau

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Adult subjects who experienced a cerebral infarction extended the sylvian area, and having received treatment by decompressive craniectomy.

描述

Inclusion Criteria:

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

Exclusion Criteria:

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
Minors
Major under curators

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
craniectomy Adult subjects who experienced a cerebral infarction extended the sylvian area, and having received treatment by decompressive craniectomy.

研究衡量的是什么？

主要结果指标

结果测量	大体时间
To assess the quality of life for long-term patients victims of malignant sylvian ischemic stroke who received decompressive craniectomy. 大体时间：at least two years	at least two years

次要结果测量

结果测量	大体时间
To evaluate the quality of life in the physical and psychosocial domains 大体时间：at least two years	at least two years
To evaluate the evolution of functional disability 大体时间：At 3 months, 12 months and 24 months.	At 3 months, 12 months and 24 months.
To evaluate the life satisfaction 大体时间：at least two years	at least two years
To assess the rate of recovery work 大体时间：at least two years	at least two years
To evaluate the retrospective review of patients achieving craniectomy 大体时间：at least two years	at least two years
To determine the prognostic factors that influence the level of handicap and quality of life in the long term. 大体时间：at least two years	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. 大体时间：at least two years	at least two years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nantes University Hospital

调查人员

首席研究员：SÉVIN ALLOUET Mathieu, Dr、Nantes university hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年6月1日

初级完成 (实际的)

2013年2月1日

研究完成 (实际的)

2013年7月1日

研究注册日期

首次提交

2013年10月25日

首先提交符合 QC 标准的

2013年11月15日

首次发布 (估计)

2013年11月21日

研究记录更新

最后更新发布 (实际的)

2021年9月10日

上次提交的符合 QC 标准的更新

2021年9月8日

最后验证

2021年9月1日