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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; Decompressive Craniectomy

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• France
  • Angers, France
    • CHU Angers
  • Brest, France
    • CHU de Brest
  • Rennes, France
    • CH R U Pontchaillou
  • Tours, France
    • Chu Bretonneau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
To evaluate the quality of life in the physical and psychosocial domains	at least two years
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 retrospective review of patients achieving craniectomy	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: November 15, 2013
• First Posted (Estimate): November 21, 2013

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: BRD/10/08-I