Long-term Outcomes in Terms of Disability and Quality of Life for Patients Undergoing Posterior Cranial Fossa Craniectomy in the Context of Compressive Cerebellar Hematoma (CHANCE)
2021年5月27日 更新者:University Hospital, Grenoble
Posterior cranial fossa craniectomy has been shown to improve patient survival. The level of autonomy, disability and quality of life of survivors has been little studied and still underresearched,.
In this context, an assessment of the level of disability and of the quality of life after performing a posterior craniectomy seems relevant.
研究概览
详细说明
Investigators are carrying out a retrospective observational, single-center study, in three intensive care units in the Grenoble Hospital Center.
Every patients who underwent a posterior fossa craniectomy for a cerebellar hematoma at Grenoble University Hospital between 01/01/2010 and 01/01/2020 were enrolled in this study.
The main objective is to assess the level of disability and the quality of life of patients who have had a posterior cranial fossa craniectomy.
The primary outcome is the mRS(Modified Rankin score) measured at least one year following the ICU discharge.
Secondary outcomes are the mRS(Modified Rankin Score) measured at discharge from the rehabilitation department, the GOS (Glasgow Outcome score) measured at least one year following the discharge from intensive care, and the SF36 (The Short Form 36)from the medical outcome study, score assessing the quality of life, collected via phone call.
研究类型
观察性的
注册 (实际的)
26
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
-
-
-
Grenoble、法国、38043
- CHUGA
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-
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
非概率样本
研究人群
Every patients who underwent a posterior fossa craniectomy for a cerebellar hematoma at Grenoble University Hospital between 01/01/2010 and 01/01/2020
描述
Inclusion Criteria:
- Patient who underwent a posterior cranial fossa craniectomy in the context of an acute cerebellar hematoma between January 01, 2012 to January 01, 2020.
- Adult man or woman
- Hospitalized in intensive care
- No opposition from the patient or a loved one to a telephone contact to determine the SF36 (The Short Form) quality of life scale, from the medical outcome study.
Exclusion Criteria:
- Subject under guardianship or subject deprived of liberty
- Early limitation of active therapy before 48 hours.
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients who underwent a posterior fossa craniectomy for a cerebellar hematoma
|
patients who underwent a posterior fossa craniectomy for a cerebellar hematoma at Grenoble University Hospital between 01/01/2010 and 01/01/2020 were enrolled in this study.
The main objective is to assess the level of disability and the quality of life of patients who have had a posterior cranial fossa craniectomy.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluate the level of handicap
大体时间:through study completion, an average of 1 years post admission
|
The mRS (Modified Ranking score) measured at least one year following the ICU discharge during the consultation after hospitalization in the medical file
|
through study completion, an average of 1 years post admission
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Global quality of life score
大体时间:from january 2020, during 6 months
|
the SF36 score assessing the quality of life, collected via phone call.
|
from january 2020, during 6 months
|
|
Neurological recovery
大体时间:from january 2020, during 6 months
|
the GOS (Glasgow Outcome Scale) score measured at least one year following the discharge from intensive care. It goes from 1 to 5. 1 corresponds to death 5.Good Recovery |
from january 2020, during 6 months
|
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。
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 (实际的)
2020年12月17日
初级完成 (实际的)
2021年2月26日
研究完成 (实际的)
2021年5月12日
研究注册日期
首次提交
2020年12月11日
首先提交符合 QC 标准的
2020年12月16日
首次发布 (实际的)
2020年12月17日
研究记录更新
最后更新发布 (实际的)
2021年5月28日
上次提交的符合 QC 标准的更新
2021年5月27日
最后验证
2021年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.