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The efficacy of dexamethasone on reduction in the reoperation rate of chronic subdural hematoma – the DRESH study: straightforward study protocol for a randomized controlled trial

BACKGROUND: Chronic subdural hematoma (cSDH) is a common neurosurgical disease. It is often considered to be a rather benign entity. In spite of well established surgical procedures cSDH is complicated by a recurrence rate up to 30%. Since glucocorticoids have been used for treatment of cSDH in 1962...

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Autores principales: Emich, Stephan, Richling, Bernd, McCoy, Marc R, Al-Schameri, Rahman Abdul, Ling, Feng, Sun, Liyong, Wang, Yabing, Hitzl, Wolfgang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3891985/
https://www.ncbi.nlm.nih.gov/pubmed/24393328
http://dx.doi.org/10.1186/1745-6215-15-6
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author Emich, Stephan
Richling, Bernd
McCoy, Marc R
Al-Schameri, Rahman Abdul
Ling, Feng
Sun, Liyong
Wang, Yabing
Hitzl, Wolfgang
author_facet Emich, Stephan
Richling, Bernd
McCoy, Marc R
Al-Schameri, Rahman Abdul
Ling, Feng
Sun, Liyong
Wang, Yabing
Hitzl, Wolfgang
author_sort Emich, Stephan
collection PubMed
description BACKGROUND: Chronic subdural hematoma (cSDH) is a common neurosurgical disease. It is often considered to be a rather benign entity. In spite of well established surgical procedures cSDH is complicated by a recurrence rate up to 30%. Since glucocorticoids have been used for treatment of cSDH in 1962 their role is still discussed controversially in lack of evident data. On the basis of the ascertained inflammation cycle in cSDH dexamethasone will be an ideal substance for a short lasting, concomitant treatment protocol. Objective: to test the efficacy of dexamethasone on reduction inthe reoperation rate of cSDH. METHODS/DESIGN: The study is designed as a double-blind randomized placebo-controlled trial 820 patients who are operated for cSDH and from the age of 25 years are included after obtaining informed consent. They are randomized for administration of dexamethasone (16-16-12-12-8-4 mg/d) or placebo (maltodextrin) during the first 48 hours after surgery. The type I error is 5% and the type II error is 20%. The primary endpoint is the reoperation within 12 weeks postoperative. DISCUSSION: This study tests whether dexamethasone administered over 6 days is a safe and potent agent in relapse prevention for evacuated cSDH. TRIAL REGISTRATION: EudraCT 201100354442
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spelling pubmed-38919852014-01-15 The efficacy of dexamethasone on reduction in the reoperation rate of chronic subdural hematoma – the DRESH study: straightforward study protocol for a randomized controlled trial Emich, Stephan Richling, Bernd McCoy, Marc R Al-Schameri, Rahman Abdul Ling, Feng Sun, Liyong Wang, Yabing Hitzl, Wolfgang Trials Study Protocol BACKGROUND: Chronic subdural hematoma (cSDH) is a common neurosurgical disease. It is often considered to be a rather benign entity. In spite of well established surgical procedures cSDH is complicated by a recurrence rate up to 30%. Since glucocorticoids have been used for treatment of cSDH in 1962 their role is still discussed controversially in lack of evident data. On the basis of the ascertained inflammation cycle in cSDH dexamethasone will be an ideal substance for a short lasting, concomitant treatment protocol. Objective: to test the efficacy of dexamethasone on reduction inthe reoperation rate of cSDH. METHODS/DESIGN: The study is designed as a double-blind randomized placebo-controlled trial 820 patients who are operated for cSDH and from the age of 25 years are included after obtaining informed consent. They are randomized for administration of dexamethasone (16-16-12-12-8-4 mg/d) or placebo (maltodextrin) during the first 48 hours after surgery. The type I error is 5% and the type II error is 20%. The primary endpoint is the reoperation within 12 weeks postoperative. DISCUSSION: This study tests whether dexamethasone administered over 6 days is a safe and potent agent in relapse prevention for evacuated cSDH. TRIAL REGISTRATION: EudraCT 201100354442 BioMed Central 2014-01-06 /pmc/articles/PMC3891985/ /pubmed/24393328 http://dx.doi.org/10.1186/1745-6215-15-6 Text en Copyright © 2014 Emich et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Emich, Stephan
Richling, Bernd
McCoy, Marc R
Al-Schameri, Rahman Abdul
Ling, Feng
Sun, Liyong
Wang, Yabing
Hitzl, Wolfgang
The efficacy of dexamethasone on reduction in the reoperation rate of chronic subdural hematoma – the DRESH study: straightforward study protocol for a randomized controlled trial
title The efficacy of dexamethasone on reduction in the reoperation rate of chronic subdural hematoma – the DRESH study: straightforward study protocol for a randomized controlled trial
title_full The efficacy of dexamethasone on reduction in the reoperation rate of chronic subdural hematoma – the DRESH study: straightforward study protocol for a randomized controlled trial
title_fullStr The efficacy of dexamethasone on reduction in the reoperation rate of chronic subdural hematoma – the DRESH study: straightforward study protocol for a randomized controlled trial
title_full_unstemmed The efficacy of dexamethasone on reduction in the reoperation rate of chronic subdural hematoma – the DRESH study: straightforward study protocol for a randomized controlled trial
title_short The efficacy of dexamethasone on reduction in the reoperation rate of chronic subdural hematoma – the DRESH study: straightforward study protocol for a randomized controlled trial
title_sort efficacy of dexamethasone on reduction in the reoperation rate of chronic subdural hematoma – the dresh study: straightforward study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3891985/
https://www.ncbi.nlm.nih.gov/pubmed/24393328
http://dx.doi.org/10.1186/1745-6215-15-6
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