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Study protocol
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
Chiyuan Ma
Jinling Hospital, Nanjing University
Corresponding Author
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
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.
Keywords
endoscopic surgery, external ventricular drainage, intraventricular hemorrhage
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CURRENT STATUS: Published
Version 3
Posted 15 Jun, 2020
Published
On 13 Jul, 2020
No community comments so far
Editorial decision: Accept
On 26 Jun, 2020
Reviewers invited
Invitations sent on 21 Jun, 2020
Editor assigned
On 12 Jun, 2020
Submission checks complete
On 11 Jun, 2020
No comments provided
Editorial decision: Major revision
On 15 May, 2020
Reviewer #2 agreed
On 08 May, 2020
Review #2 received
Received 08 May, 2020
Review #1 received
Received 16 Mar, 2020
Reviewer #1 agreed
On 15 Mar, 2020
Reviewers invited
Invitations sent on 12 Mar, 2020
Editor assigned
On 04 Mar, 2020
Submission checks complete
On 03 Mar, 2020
No comments provided
Editorial decision: Major revision
On 19 Feb, 2020
Review #2 received
Received 12 Feb, 2020
Reviewer #2 agreed
On 07 Feb, 2020
Review #1 received
Received 03 Feb, 2020
Reviewers invited
Invitations sent on 30 Jan, 2020
Reviewer #1 agreed
On 30 Jan, 2020
Editor assigned
On 18 Nov, 2019
Submission checks complete
On 23 Oct, 2019
First submitted
On 18 Oct, 2019
Metrics
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
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
Chiyuan Ma
Jinling Hospital, Nanjing University
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 3
Posted 15 Jun, 2020
Published
On 13 Jul, 2020
No community comments so far
Editorial decision: Accept
On 26 Jun, 2020
Reviewers invited
Invitations sent on 21 Jun, 2020
Editor assigned
On 12 Jun, 2020
Submission checks complete
On 11 Jun, 2020
No comments provided
Editorial decision: Major revision
On 15 May, 2020
Reviewer #2 agreed
On 08 May, 2020
Review #2 received
Received 08 May, 2020
Review #1 received
Received 16 Mar, 2020
Reviewer #1 agreed
On 15 Mar, 2020
Reviewers invited
Invitations sent on 12 Mar, 2020
Editor assigned
On 04 Mar, 2020
Submission checks complete
On 03 Mar, 2020
No comments provided
Editorial decision: Major revision
On 19 Feb, 2020
Review #2 received
Received 12 Feb, 2020
Reviewer #2 agreed
On 07 Feb, 2020
Review #1 received
Received 03 Feb, 2020
Reviewers invited
Invitations sent on 30 Jan, 2020
Reviewer #1 agreed
On 30 Jan, 2020
Editor assigned
On 18 Nov, 2019
Submission checks complete
On 23 Oct, 2019
First submitted
On 18 Oct, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
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.
Figure 1