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Assessment of Evidence Regarding Minimally Invasive Surgery vs. Conservative Treatment on Intracerebral Hemorrhage: A Trial Sequential Analysis of Randomized Controlled Trials

Introduction: The recent publication of a trial failed to prove the efficacy of minimally invasive surgery (MIS) in patients with intracerebral hemorrhage. The aim of this study was to answer the question: Do we need more trials to compare MIS vs. conservative treatment in these patients? Methods: D...

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Autores principales: Zhou, Xiang, Xie, Li, Altinel, Yuksel, Qiao, Nidan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7287205/
https://www.ncbi.nlm.nih.gov/pubmed/32582000
http://dx.doi.org/10.3389/fneur.2020.00426
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author Zhou, Xiang
Xie, Li
Altinel, Yuksel
Qiao, Nidan
author_facet Zhou, Xiang
Xie, Li
Altinel, Yuksel
Qiao, Nidan
author_sort Zhou, Xiang
collection PubMed
description Introduction: The recent publication of a trial failed to prove the efficacy of minimally invasive surgery (MIS) in patients with intracerebral hemorrhage. The aim of this study was to answer the question: Do we need more trials to compare MIS vs. conservative treatment in these patients? Methods: Databases were searched for relevant randomized trials on MIS (endoscopic surgery or stereotactic evacuation) vs. conservative treatment. The primary outcome was significant neurological debilitation or death at the follow-up, and the secondary outcome was death. Both conventional meta-analysis and trial sequential analysis (TSA) were performed. Results: Twelve trials with 2,049 patients were included. In the conventional meta-analysis, the risk ratios of MIS vs. conservative treatment were 0.82 [95% confidence interval (CI), 0.72–0.94] and 0.74 (95% CI, 0.62–0.88) for the primary and secondary outcomes, respectively. In TSA, the cumulative z curve crossed the superiority boundary, which confirmed an 18.8% relative risk reduction of MIS vs. conservative treatment for the primary outcome. It was also highly likely that MIS would reduce mortality by 24.3%. Several sensitivity analyses suggested the robustness of our results, including different prior settings, including only trials with blind outcome assessment, and the assumption of future trials to be futile. Conclusions: Minimally invasive surgery seems to be more effective than conservative treatment in patients with intracerebral hemorrhage in reducing both morbidity and mortality. Repeating a clinical trial with similar devices, design, and outcomes is unlikely to change the current evidence.
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spelling pubmed-72872052020-06-23 Assessment of Evidence Regarding Minimally Invasive Surgery vs. Conservative Treatment on Intracerebral Hemorrhage: A Trial Sequential Analysis of Randomized Controlled Trials Zhou, Xiang Xie, Li Altinel, Yuksel Qiao, Nidan Front Neurol Neurology Introduction: The recent publication of a trial failed to prove the efficacy of minimally invasive surgery (MIS) in patients with intracerebral hemorrhage. The aim of this study was to answer the question: Do we need more trials to compare MIS vs. conservative treatment in these patients? Methods: Databases were searched for relevant randomized trials on MIS (endoscopic surgery or stereotactic evacuation) vs. conservative treatment. The primary outcome was significant neurological debilitation or death at the follow-up, and the secondary outcome was death. Both conventional meta-analysis and trial sequential analysis (TSA) were performed. Results: Twelve trials with 2,049 patients were included. In the conventional meta-analysis, the risk ratios of MIS vs. conservative treatment were 0.82 [95% confidence interval (CI), 0.72–0.94] and 0.74 (95% CI, 0.62–0.88) for the primary and secondary outcomes, respectively. In TSA, the cumulative z curve crossed the superiority boundary, which confirmed an 18.8% relative risk reduction of MIS vs. conservative treatment for the primary outcome. It was also highly likely that MIS would reduce mortality by 24.3%. Several sensitivity analyses suggested the robustness of our results, including different prior settings, including only trials with blind outcome assessment, and the assumption of future trials to be futile. Conclusions: Minimally invasive surgery seems to be more effective than conservative treatment in patients with intracerebral hemorrhage in reducing both morbidity and mortality. Repeating a clinical trial with similar devices, design, and outcomes is unlikely to change the current evidence. Frontiers Media S.A. 2020-06-04 /pmc/articles/PMC7287205/ /pubmed/32582000 http://dx.doi.org/10.3389/fneur.2020.00426 Text en Copyright © 2020 Zhou, Xie, Altinel and Qiao. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neurology
Zhou, Xiang
Xie, Li
Altinel, Yuksel
Qiao, Nidan
Assessment of Evidence Regarding Minimally Invasive Surgery vs. Conservative Treatment on Intracerebral Hemorrhage: A Trial Sequential Analysis of Randomized Controlled Trials
title Assessment of Evidence Regarding Minimally Invasive Surgery vs. Conservative Treatment on Intracerebral Hemorrhage: A Trial Sequential Analysis of Randomized Controlled Trials
title_full Assessment of Evidence Regarding Minimally Invasive Surgery vs. Conservative Treatment on Intracerebral Hemorrhage: A Trial Sequential Analysis of Randomized Controlled Trials
title_fullStr Assessment of Evidence Regarding Minimally Invasive Surgery vs. Conservative Treatment on Intracerebral Hemorrhage: A Trial Sequential Analysis of Randomized Controlled Trials
title_full_unstemmed Assessment of Evidence Regarding Minimally Invasive Surgery vs. Conservative Treatment on Intracerebral Hemorrhage: A Trial Sequential Analysis of Randomized Controlled Trials
title_short Assessment of Evidence Regarding Minimally Invasive Surgery vs. Conservative Treatment on Intracerebral Hemorrhage: A Trial Sequential Analysis of Randomized Controlled Trials
title_sort assessment of evidence regarding minimally invasive surgery vs. conservative treatment on intracerebral hemorrhage: a trial sequential analysis of randomized controlled trials
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7287205/
https://www.ncbi.nlm.nih.gov/pubmed/32582000
http://dx.doi.org/10.3389/fneur.2020.00426
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