Craniectomy Protocol

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01990014

Enrollment

Registered

2013-11-21

Start date

2011-06-30

Completion date

2013-07-31

Last updated

2021-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decompressive Craniectomy, Ischemic Stroke

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To assess the quality of life for long-term patients victims of malignant sylvian ischemic stroke who received decompressive craniectomy.	at least two years

Secondary

Measure	Time frame
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 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 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

Countries

France

Outcome results