Endoscopic surgery versus conservative treatment for the moderate-volume hematoma in spontaneous basal ganglia hemorrhage ECMOH: study protocol for a randomized controlled trialReportar como inadecuado




Endoscopic surgery versus conservative treatment for the moderate-volume hematoma in spontaneous basal ganglia hemorrhage ECMOH: study protocol for a randomized controlled trial - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

BMC Neurology

, 12:34

First Online: 07 June 2012Received: 22 December 2011Accepted: 24 May 2012

Abstract

BackgroundSpontaneous intracerebral hemorrhage is a disease with high morbidity, high disability rate, high mortality, and high economic burden. Whether patients can benefit from surgical evacuation of hematomas is still controversial, especially for those with moderate-volume hematomas in the basal ganglia. This study is designed to compare the efficacy of endoscopic surgery and conservative treatment for the moderate-volume hematoma in spontaneous basal ganglia hemorrhage.

MethodsPatients meet the criteria will be randomized into the endoscopic surgery group endoscopic surgery for hematoma evacuation and the best medical treatment or the conservative treatment group the best medical treatment. Patients will be followed up at 1, 3, and 6 months after initial treatment. The primary outcomes include the Extended Glasgow Outcome Scale and the Modified Rankin Scale. The secondary outcomes consist of the National Institutes of Health Stroke Scale and the mortality. The Barthel IndexBI will also be evaluated. The sample size is 100 patients.

DiscussionThe ECMOH trial is a randomized controlled trial designed to evaluate if endoscopic surgery is better than conservative treatment for patients with moderate-volume hematomas in the basal ganglia.

Trial registrationChinese Clinical Trial Registry: ChiCTR-TRC-11001614

http:-www.chictr.org-en-proj-show.aspx?proj=1618

KeywordsEndoscopic surgery Conservative treatment Moderate-volume hematoma Spontaneous basal ganglia hemorrhage AbbreviationsECMOHEndoscopic surgery versus conservative treatment for the moderate-volume hematoma

SICHSpontaneous Intracerebral Hemorrhage

CTComputed Tomography

GCSGlasgow Coma Score

CRFCase Report Form

QMBQuality Monitoring Board

GOSEExtended Glasgow Outcome Scale

mRSModified Rankin Scale

NIHSSNational Institutes of Health Stroke Scale

BIBarthel Index

BMECBiological and Medical Ethics Committee

AEAdverse Event

SAESevere Adverse Event

ITTIntention To Treat

PPPer-Protocol.

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Autor: Xin Zan - Hao Li - Wenke Liu - Yuan Fang - Junpeng Ma - Zhigang Lan - Xi Li - Xin Liu - Chao You

Fuente: https://link.springer.com/







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