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Comparative effectiveness of different surgical procedures for traumatic acute epidural haematoma: study protocol for Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases (PORTALS-AEDH)
INTRODUCTION: Controversy and variation exist in surgical management for acute epidural haematoma (AEDH). Although craniotomy for AEDH is conventionally employed, no specific evaluation on the necessity of decompressive craniectomy (DC) followed by AEDH evacuation has been performed. METHODS AND ANA...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8915281/ https://www.ncbi.nlm.nih.gov/pubmed/35264341 http://dx.doi.org/10.1136/bmjopen-2021-051247 |
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author | Yang, Chun Hui, Jiyuan Xie, Li Feng, Junfeng Jiang, Jiyao |
author_facet | Yang, Chun Hui, Jiyuan Xie, Li Feng, Junfeng Jiang, Jiyao |
author_sort | Yang, Chun |
collection | PubMed |
description | INTRODUCTION: Controversy and variation exist in surgical management for acute epidural haematoma (AEDH). Although craniotomy for AEDH is conventionally employed, no specific evaluation on the necessity of decompressive craniectomy (DC) followed by AEDH evacuation has been performed. METHODS AND ANALYSIS: This is a multicentre prospective, phase III observational study that evaluates different surgical managements for the AEDH. Patients of both genders, aged 18–65 years, presenting to the emergency room with a clinical and radiological diagnosis of AEDH, complying with other inclusion and exclusion criteria, are enrolled. Clinical information, including diagnosis of AEDH, radiological information, treatment procedures and follow-up data of 1, 3 and 6 months post-injury, is collected on 2000 eligible patients among 263 hospitals in China. Recruitment for the study started in April 2021, and inclusion will be continued until the sample size is obtained, expected is an inclusion period of 24 months. The interventions of concern are surgical treatments for AEDH, including craniotomy and DC. The primary outcome is the Glasgow Outcome Score-Extended 6 months post-injury. Secondary outcomes include the incidence of postoperative cerebral infarction, the incidence of additional craniocerebral surgery and other evaluation indicators within 6 months post-injury. ETHICS AND DISSEMINATION: The study protocol has been approved by the ethics committee and institutional review board of Renji Hospital, School of Medicine, Shanghai Jiao Tong University. All study investigators strictly follow the Declaration of Helsinki and Human Biomedical Research Ethical Issues. Signed written informed consent will be obtained from all enrolled patients. The trial results will be disseminated through academic conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04229966. |
format | Online Article Text |
id | pubmed-8915281 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-89152812022-03-25 Comparative effectiveness of different surgical procedures for traumatic acute epidural haematoma: study protocol for Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases (PORTALS-AEDH) Yang, Chun Hui, Jiyuan Xie, Li Feng, Junfeng Jiang, Jiyao BMJ Open Surgery INTRODUCTION: Controversy and variation exist in surgical management for acute epidural haematoma (AEDH). Although craniotomy for AEDH is conventionally employed, no specific evaluation on the necessity of decompressive craniectomy (DC) followed by AEDH evacuation has been performed. METHODS AND ANALYSIS: This is a multicentre prospective, phase III observational study that evaluates different surgical managements for the AEDH. Patients of both genders, aged 18–65 years, presenting to the emergency room with a clinical and radiological diagnosis of AEDH, complying with other inclusion and exclusion criteria, are enrolled. Clinical information, including diagnosis of AEDH, radiological information, treatment procedures and follow-up data of 1, 3 and 6 months post-injury, is collected on 2000 eligible patients among 263 hospitals in China. Recruitment for the study started in April 2021, and inclusion will be continued until the sample size is obtained, expected is an inclusion period of 24 months. The interventions of concern are surgical treatments for AEDH, including craniotomy and DC. The primary outcome is the Glasgow Outcome Score-Extended 6 months post-injury. Secondary outcomes include the incidence of postoperative cerebral infarction, the incidence of additional craniocerebral surgery and other evaluation indicators within 6 months post-injury. ETHICS AND DISSEMINATION: The study protocol has been approved by the ethics committee and institutional review board of Renji Hospital, School of Medicine, Shanghai Jiao Tong University. All study investigators strictly follow the Declaration of Helsinki and Human Biomedical Research Ethical Issues. Signed written informed consent will be obtained from all enrolled patients. The trial results will be disseminated through academic conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04229966. BMJ Publishing Group 2022-03-09 /pmc/articles/PMC8915281/ /pubmed/35264341 http://dx.doi.org/10.1136/bmjopen-2021-051247 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Surgery Yang, Chun Hui, Jiyuan Xie, Li Feng, Junfeng Jiang, Jiyao Comparative effectiveness of different surgical procedures for traumatic acute epidural haematoma: study protocol for Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases (PORTALS-AEDH) |
title | Comparative effectiveness of different surgical procedures for traumatic acute epidural haematoma: study protocol for Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases (PORTALS-AEDH) |
title_full | Comparative effectiveness of different surgical procedures for traumatic acute epidural haematoma: study protocol for Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases (PORTALS-AEDH) |
title_fullStr | Comparative effectiveness of different surgical procedures for traumatic acute epidural haematoma: study protocol for Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases (PORTALS-AEDH) |
title_full_unstemmed | Comparative effectiveness of different surgical procedures for traumatic acute epidural haematoma: study protocol for Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases (PORTALS-AEDH) |
title_short | Comparative effectiveness of different surgical procedures for traumatic acute epidural haematoma: study protocol for Prospective, Observational Real-world Treatments of AEDH in Large-scale Surgical Cases (PORTALS-AEDH) |
title_sort | comparative effectiveness of different surgical procedures for traumatic acute epidural haematoma: study protocol for prospective, observational real-world treatments of aedh in large-scale surgical cases (portals-aedh) |
topic | Surgery |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8915281/ https://www.ncbi.nlm.nih.gov/pubmed/35264341 http://dx.doi.org/10.1136/bmjopen-2021-051247 |
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