Craniectomy Protocol

Completed

• Conditions: Ischemic Stroke; Decompressive Craniectomy

• Registration Number: NCT01990014
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2013-02
• Study Completion: 2013-07
• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2013-11-15
• Study First Posted: 2013-11-21
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 evaluate the evolution of functional disability	At 3 months, 12 months and 24 months.
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

Trial Locations

Locations (4)

CHU Angers; 🇫🇷 Angers, France

CH R U Pontchaillou; 🇫🇷 Rennes, France

CHU de Brest; 🇫🇷 Brest, France

CHU Bretonneau; 🇫🇷 Tours, France