Clinical trial NCT01990014: Craniectomy Protocol
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Decompressive Craniectomy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult subjects who experienced a cerebral infarction extended the sylvian area, and having received treatment by decompressive craniectomy.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess the quality of life for long-term patients victims of malignant sylvian ischemic stroke who received decompressive craniectomy.
timeFrame: at least two years
Secondary outcomes:
measure: To evaluate the quality of life in the physical and psychosocial domains
timeFrame: at least two years
measure: To evaluate the evolution of functional disability
timeFrame: At 3 months, 12 months and 24 months.
measure: To evaluate the life satisfaction
timeFrame: at least two years
measure: To assess the rate of recovery work
timeFrame: at least two years
measure: To evaluate the retrospective review of patients achieving craniectomy
timeFrame: at least two years
measure: To determine the prognostic factors that influence the level of handicap and quality of life in the long term.
timeFrame: at least two years
measure: 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.
timeFrame: at least two years
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHU de Brest
city: Rennes
country: France
facility: CH R U Pontchaillou
city: Tours
country: France
facility: CHU Bretonneau
Study officials:
affiliation: Nantes University Hospital
name: SÉVIN ALLOUET Mathieu, Dr
role: PRINCIPAL_INVESTIGATOR
References: