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Craniectomy Protocol

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01990014
Collaborator
(none)
62
Enrollment
4
Locations
25
Duration (Months)
15.5
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    62 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    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 Start Date :
    Jun 1, 2011
    Actual Primary Completion Date :
    Feb 1, 2013
    Actual Study Completion Date :
    Jul 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    craniectomy

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

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. To evaluate the quality of life in the physical and psychosocial domains [at least two years]

    2. To evaluate the evolution of functional disability [At 3 months, 12 months and 24 months.]

    3. To evaluate the life satisfaction [at least two years]

    4. To assess the rate of recovery work [at least two years]

    5. To evaluate the retrospective review of patients achieving craniectomy [at least two years]

    6. To determine the prognostic factors that influence the level of handicap and quality of life in the long term. [at least two years]

    7. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Angers Angers France
    2 CHU de Brest Brest France
    3 CH R U Pontchaillou Rennes France
    4 CHU Bretonneau Tours France

    Sponsors and Collaborators

    • Nantes University Hospital

    Investigators

    • Principal Investigator: SÉVIN ALLOUET Mathieu, Dr, Nantes University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nantes University Hospital
    ClinicalTrials.gov Identifier:
    NCT01990014
    Other Study ID Numbers:
    • BRD/10/08-I
    First Posted:
    Nov 21, 2013
    Last Update Posted:
    Sep 10, 2021
    Last Verified:
    Sep 1, 2021
    Additional relevant MeSH terms:
    Ischemic Stroke

    Study Results

    No Results Posted as of Sep 10, 2021