Enhancing Safety in Epilepsy Surgery (EASINESS): Study Protocol for a Retrospective, Multicenter, Open Registry
Frontiers in Neurology, vol. 12, pp. 782666
Abstract
Introduction: Optimizing patient safety and quality improvement is increasingly important in surgery. Benchmarks and clinical quality registries are being developed to assess the best achievable results for several surgical procedures and reduce unwarranted variation between different centers. However, there is no clinical database from international centers for establishing standardized reference values of patients undergoing surgery for mesial temporal lobe epilepsy. Design: The Enhancing Safety in Epilepsy Surgery (EASINESS) study is a retrospectively conducted, multicenter, open registry. All patients undergoing mesial temporal lobe epilepsy surgery in participating centers between January 2015 and December 2019 are included in this study. The patient characteristics, preoperative diagnostic tools, surgical data, postoperative complications, and long-term seizure outcomes are recorded. Outcomes: The collected data will be used for establishing standardized reference values (“benchmarks”) for this type of surgical procedure. The primary endpoints include seizure outcomes according to the International League Against Epilepsy (ILAE) classification and defined postoperative complications. Discussion: The EASINESS will define robust and standardized outcome references after amygdalohippocampectomy for temporal lobe epilepsy. After the successful definition of benchmarks from an international cohort of renowned centers, these data will serve as reference values for the evaluation of novel surgical techniques and comparisons among centers for future clinical trials. Clinical trial registration: This study is indexed at clinicaltrials.gov (NT 04952298).
Authors 47
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Richard Drexler corresponding
University Medical Center Hamburg-Eppendorf
Affiliation as printed
Department of Neurosurgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
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University of California San Diego
Affiliation as printed
Department of Neurosurgery, University of California San Diego, San Diego, CA, United States
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Affiliation as printed
Epilepsy Centre Bethel, Krankenhaus Mara, Bielefeld, Germany
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Affiliation as printed
Department of Neurosurgery, University Hospital Bonn, Bonn, Germany
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Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Affiliation as printed
"C. Munari" Epilepsy Surgery Center, Niguarda Hospital, Milan, Italy
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Affiliation as printed
Department of Neurosurgery, Pitié-Salpêtrière Hospital, Paris, France
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Universidade Estadual de Campinas (UNICAMP)
Affiliation as printed
Department of Neurology, University of Campinas, Campinas, Brazil
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All India Institute of Medical Sciences
Affiliation as printed
Department of Neurosurgery, AIIMS, New Delhi, India
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Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Department of Neurosurgery, University Hospital RWTH Aachen, Aachen, Germany
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Affiliation as printed
School for Mental Health and Neuroscience (MHeNS), University Maastricht (UM), Maastricht, Netherlands
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Fondazione IRCCS Istituto Neurologico Carlo Besta
Affiliation as printed
Epilepsy Unit, IRCCS "C. Besta" Neurological Institute Foundation, Milan, Italy
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Universitätsklinikum Aachen · RWTH Aachen University
Affiliation as printed
Department of Neurosurgery, University Hospital RWTH Aachen, Aachen, Germany
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Fondazione IRCCS Istituto Neurologico Carlo Besta
Affiliation as printed
Epilepsy Unit, IRCCS "C. Besta" Neurological Institute Foundation, Milan, Italy
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University Medical Center Hamburg-Eppendorf
Affiliation as printed
Department of Neurosurgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
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Affiliation as printed
The Walton Centre NHS Foundation Trust, Liverpool, United Kingdom
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Université de Lyon · Hospices Civils de Lyon · Hôpital Pierre Wertheimer
Affiliation as printed
Department for Neurosurgery, University of Lyon, Lyon, France
Department of Functional Neurosurgery, P. Wertheimer Hospital, Hospices Civils de Lyon, Lyon, France
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Icahn School of Medicine at Mount Sinai
Affiliation as printed
Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY, United States
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Université de Lyon · Hospices Civils de Lyon · Hôpital Pierre Wertheimer
Affiliation as printed
Department for Neurosurgery, University of Lyon, Lyon, France
Department of Functional Neurosurgery, P. Wertheimer Hospital, Hospices Civils de Lyon, Lyon, France
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Friedrich-Alexander-Universität Erlangen-Nürnberg
Affiliation as printed
Epilepsy Center, Department of Neurology, University of Erlangen-Nürnberg, Erlangen, Germany
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Affiliation as printed
Department of Neurosurgery, University of Washington, Seattle, WA, United States
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The University of Queensland · Royal Brisbane and Women's Hospital
Affiliation as printed
Department of Neurosurgery, Royal Brisbane and Womens Hospital, Brisbane, QLD, Australia
Herston Clinical School, University of Queensland, Brisbane, QLD, Australia
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Affiliation as printed
Department of Neurosurgery (Evangelisches Klinikum Bethel), Bielefeld University, Medical School, Bielefeld, Germany
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Hertie Institute for Clinical Brain Research · University of Tübingen
Affiliation as printed
Department of Neurology and Epileptology, Hertie Institute of Clinical Brain Research, University of Tubingen, Tubingen, Germany
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University of Zurich · University Children's Hospital Zurich
Affiliation as printed
Division of Pediatric Neurosurgery, University Children's Hospital Zurich, University of Zurich, Zurich, Switzerland
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Friedrich-Alexander-Universität Erlangen-Nürnberg
Affiliation as printed
Epilepsy Center, Department of Neurology, University of Erlangen-Nürnberg, Erlangen, Germany
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Affiliation as printed
Department of Neurosurgery, Pitié-Salpêtrière Hospital, Paris, France
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Hertie Institute for Clinical Brain Research · University of Tübingen
Affiliation as printed
Department of Neurology and Epileptology, Hertie Institute of Clinical Brain Research, University of Tubingen, Tubingen, Germany
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Charité - Universitätsmedizin Berlin
Affiliation as printed
Department of Neurosurgery, Universitätsmedizin Charité-Berlin, Berlin, Germany
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Icahn School of Medicine at Mount Sinai
Affiliation as printed
Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, NY, United States
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Affiliation as printed
Department of Neurosurgery, University Hospital St-Luc, Université Catholique de Louvain (UCL), Brussels, Belgium
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University Medical Center Hamburg-Eppendorf
Affiliation as printed
Department of Neurosurgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
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Maastricht University Medical Centre
Affiliation as printed
Department of Neurosurgery, Academic Center for Epileptology UMC Maastricht, Maastricht, Netherlands
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Fondazione IRCCS Istituto Neurologico Carlo Besta
Affiliation as printed
Department of Neurosurgery, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy
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Affiliation as printed
Department of Neurosurgery, Medical University Vienna, Vienna, Austria
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Maastricht University Medical Centre · Maastricht University
Affiliation as printed
Department of Neurosurgery, Academic Center for Epileptology UMC Maastricht, Maastricht, Netherlands
School for Mental Health and Neuroscience (MHeNS), University Maastricht (UM), Maastricht, Netherlands
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Charité - Universitätsmedizin Berlin
Affiliation as printed
Department of Neurosurgery, Universitätsmedizin Charité-Berlin, Berlin, Germany
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Goethe University Frankfurt · University Hospital Frankfurt
Affiliation as printed
Department of Neurosurgery and Epilepsy Center Frankfurt Rhine-Main, Center of Neurology and Neurosurgery, Goethe-University Frankfurt, Frankfurt, Germany
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Goethe University Frankfurt · University Hospital Frankfurt
Affiliation as printed
Department of Neurosurgery and Epilepsy Center Frankfurt Rhine-Main, Center of Neurology and Neurosurgery, Goethe-University Frankfurt, Frankfurt, Germany
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Evangelisches Krankenhaus Alsterdorf
Affiliation as printed
Hamburg Epilepsy Center, Protestant Hospital Alsterdorf, Department of Neurology and Epileptology, Hamburg, Germany
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All India Institute of Medical Sciences
Affiliation as printed
Department of Neurosurgery, AIIMS, New Delhi, India
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University of California, Irvine
Affiliation as printed
Department of Neurological Surgery, University of California Irvine, Irvine, CA, United States
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Instituto Nacional de Neurología y Neurocirugía
Affiliation as printed
National Institute of Neurology and Neurosurgery, Manuel Velasco Suarez, Mexico City, Mexico
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Affiliation as printed
Department of Neurosurgery, University Hospital St-Luc, Université Catholique de Louvain (UCL), Brussels, Belgium
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Universitätsklinikum Knappschaftskrankenhaus Bochum · Ruhr University Bochum
Affiliation as printed
Ruhr - Epileptology, Department of Neurology, University Hospital Knappschafts-Krankenhaus, Ruhr - University Bochum, Bochum, Germany
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Universitätsklinikum Knappschaftskrankenhaus Bochum · Ruhr University Bochum
Affiliation as printed
Ruhr - Epileptology, Department of Neurology, University Hospital Knappschafts-Krankenhaus, Ruhr - University Bochum, Bochum, Germany
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University Medical Center Hamburg-Eppendorf
Affiliation as printed
Department of Neurosurgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
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University Medical Center Hamburg-Eppendorf
Affiliation as printed
Department of Neurosurgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
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