Craniectomy Protocol

NCT ID: NCT01990014

Last Updated: 2021-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Stroke Decompressive Craniectomy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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craniectomy

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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SÉVIN ALLOUET Mathieu, Dr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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CHU Angers

Angers, , France

Site Status

CHU de Brest

Brest, , France

Site Status

CH R U Pontchaillou

Rennes, , France

Site Status

CHU Bretonneau

Tours, , France

Site Status

Countries

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France

Other Identifiers

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BRD/10/08-I

Identifier Type: -

Identifier Source: org_study_id

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