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Completed

NCT Number: NCT01990014

Craniectomy Protocol

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Decompressive Craniectomy Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To assess the quality of life for long-term patients victims of malignant sylvian ischemic stroke who received decompressive craniectomy.

    Time frame: at least two years

Secondary outcomes

  1. To evaluate the quality of life in the physical and psychosocial domains

    Time frame: at least two years

  2. To evaluate the evolution of functional disability

    Time frame: At 3 months, 12 months and 24 months.

  3. To evaluate the life satisfaction

    Time frame: at least two years

  4. To assess the rate of recovery work

    Time frame: at least two years

  5. To evaluate the retrospective review of patients achieving craniectomy

    Time frame: at least two years

  6. To determine the prognostic factors that influence the level of handicap and quality of life in the long term.

    Time frame: 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.

    Time frame: at least two years

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2013
Registry last updated
Sep 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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