Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial

Abstract Background The application of neuroendoscopy in intraventricular hemorrhage (IVH) has attracted more and more attention in recent years. Studies have shown that the use of neuroendoscopy for IVH evacuation has advantages over external ventricular drainage (EVD) alone. However, the cases of...

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Main Authors: Junhao Zhu, Chao Tang, Zixiang Cong, Jin Yang, Xiangming Cai, Chiyuan Ma, Yuxiu Liu
Format: Article
Language:English
Published: BMC 2020-07-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-020-04560-3
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author Junhao Zhu
Chao Tang
Zixiang Cong
Jin Yang
Xiangming Cai
Chiyuan Ma
Yuxiu Liu
author_facet Junhao Zhu
Chao Tang
Zixiang Cong
Jin Yang
Xiangming Cai
Chiyuan Ma
Yuxiu Liu
author_sort Junhao Zhu
collection DOAJ
description Abstract Background The application of neuroendoscopy in intraventricular hemorrhage (IVH) has attracted more and more attention in recent years. Studies have shown that the use of neuroendoscopy for IVH evacuation has advantages over external ventricular drainage (EVD) alone. However, the cases of most current research are small and all of them are retrospective studies. The aim of this study is to explore the prognosis of patients with moderate to severe IVH who undergo endoscopic IVH evacuation surgery versus those who undergo EVD alone. Methods The study is a prospective, randomized, controlled, multi-center clinical trial. Nine hundred and fifty-six subjects with moderate to severe IVH across four tertiary hospitals in China will be randomly assigned (1:1) to receive either endoscopic IVH evacuation surgery or EVD. The primary objective is to compare patients’ survival rate at 12 months after surgery. Discussion The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH. Currently, it has never been investigated in a prospective randomized controlled clinical trial. Trial registration ClinicalTrials.gov, NCT04037267 . Registered on 26 July 2019.
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spelling doaj.art-7af435a68b4140389b68ca49e1aefae72022-12-21T18:49:12ZengBMCTrials1745-62152020-07-012111810.1186/s13063-020-04560-3Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trialJunhao Zhu0Chao Tang1Zixiang Cong2Jin Yang3Xiangming Cai4Chiyuan Ma5Yuxiu Liu6Jinling Hospital, School of Medicine, Nanjing Medical UniversityDepartment of Neurosurgery, Jinling Hospital, School of Medicine, Nanjing UniversityDepartment of Neurosurgery, Jinling Hospital, School of Medicine, Nanjing UniversityJinling Hospital, School of Medicine, Nanjing Medical UniversitySchool of Medicine, Southeast UniversityJinling Hospital, School of Medicine, Nanjing Medical UniversityDepartment of Medical Statistics, Jinling Hospital, Nanjing Medical UniversityAbstract Background The application of neuroendoscopy in intraventricular hemorrhage (IVH) has attracted more and more attention in recent years. Studies have shown that the use of neuroendoscopy for IVH evacuation has advantages over external ventricular drainage (EVD) alone. However, the cases of most current research are small and all of them are retrospective studies. The aim of this study is to explore the prognosis of patients with moderate to severe IVH who undergo endoscopic IVH evacuation surgery versus those who undergo EVD alone. Methods The study is a prospective, randomized, controlled, multi-center clinical trial. Nine hundred and fifty-six subjects with moderate to severe IVH across four tertiary hospitals in China will be randomly assigned (1:1) to receive either endoscopic IVH evacuation surgery or EVD. The primary objective is to compare patients’ survival rate at 12 months after surgery. Discussion The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH. Currently, it has never been investigated in a prospective randomized controlled clinical trial. Trial registration ClinicalTrials.gov, NCT04037267 . Registered on 26 July 2019.http://link.springer.com/article/10.1186/s13063-020-04560-3Endoscopic surgeryExternal ventricular drainageIntraventricular hemorrhage
spellingShingle Junhao Zhu
Chao Tang
Zixiang Cong
Jin Yang
Xiangming Cai
Chiyuan Ma
Yuxiu Liu
Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial
Trials
Endoscopic surgery
External ventricular drainage
Intraventricular hemorrhage
title Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial
title_full Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial
title_fullStr Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial
title_full_unstemmed Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial
title_short Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial
title_sort endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage a multicenter randomized controlled trial
topic Endoscopic surgery
External ventricular drainage
Intraventricular hemorrhage
url http://link.springer.com/article/10.1186/s13063-020-04560-3
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