Craniectomy Protocol

NCT01990014 | Completed

• 1 other identifier: BRD/10/08-I
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 4

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.

Conditions

Ischemic Stroke; Decompressive Craniectomy

Outcome Measures

Primary Outcomes (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 Outcomes (7)

• 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

Study Arms (1)

craniectomy

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age\> = 18 years
• Having presented an ischemic stroke involving the sylvian area
• Having received decompressive craniectomy in acute ischemic stroke
• Signed informed consent
• Patient affiliated to a social security system

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (4)

CHU Angers

Angers, France

Location

CHU de Brest

Brest, France

Location

CH R U Pontchaillou

Rennes, France

Location

CHU Bretonneau

Tours, France

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• SÉVIN ALLOUET Mathieu, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 21, 2013
• Study Start: June 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

FR (4)