Craniectomy Protocol
8. september 2021 opdateret af: Nantes University Hospital
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.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
62
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Angers, Frankrig
- CHU Angers
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Brest, Frankrig
- CHU de Brest
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Rennes, Frankrig
- CH R U Pontchaillou
-
Tours, Frankrig
- CHU Bretonneau
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Adult subjects who experienced a cerebral infarction extended the sylvian area, and having received treatment by decompressive craniectomy.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
craniectomy
Adult subjects who experienced a cerebral infarction extended the sylvian area, and having received treatment by decompressive craniectomy.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To assess the quality of life for long-term patients victims of malignant sylvian ischemic stroke who received decompressive craniectomy.
Tidsramme: at least two years
|
at least two years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To evaluate the quality of life in the physical and psychosocial domains
Tidsramme: at least two years
|
at least two years
|
|
To evaluate the evolution of functional disability
Tidsramme: At 3 months, 12 months and 24 months.
|
At 3 months, 12 months and 24 months.
|
|
To evaluate the life satisfaction
Tidsramme: at least two years
|
at least two years
|
|
To assess the rate of recovery work
Tidsramme: at least two years
|
at least two years
|
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To evaluate the retrospective review of patients achieving craniectomy
Tidsramme: at least two years
|
at least two years
|
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To determine the prognostic factors that influence the level of handicap and quality of life in the long term.
Tidsramme: at least two years
|
at least two years
|
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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.
Tidsramme: at least two years
|
at least two years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: SÉVIN ALLOUET Mathieu, Dr, Nantes University Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2011
Primær færdiggørelse (Faktiske)
1. februar 2013
Studieafslutning (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først indsendt
25. oktober 2013
Først indsendt, der opfyldte QC-kriterier
15. november 2013
Først opslået (Skøn)
21. november 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BRD/10/08-I
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