Enhancing Safety in Epilepsy Surgery (EASINESS): Study Protocol for a Retrospective, Multicenter, Open Registry

Drexler R, Ben-Haim S, Bien CG, Borger V, Cardinale F, Carpentier A, Cendes F, Chandra S, Clusmann H, Colon A, Curtis MD, Delev D, Didato G, Duehrsen L, Farah JO, Guenot M, Ghatan S, Haegelen C, Hamer H, Hauptmann JS, Jeffree RL, Kalbhenn T, Kegele J, Krayenbuehl N, Lang J, Mathon B, Naros G, Onken J, Panov F, Raftopoulos C, Ricklefs FL, Rijkers K, Rizzi M, Roessler K, Schijns O, Schneider UC, Spyrantis A, Strzelczyk A, Stodieck S, Tripathi M, Vadera S, Alonso-Vanegas MA, Vaz JGR, Wellmer J, Wehner T, Westphal M, Sauvigny T (2021)

Publication Type: Journal article

Publication year: 2021

Journal

Book Volume: 12

DOI: 10.3389/fneur.2021.782666

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 with CRIS profile

Involved external institutions

Maastricht University Netherlands (NL) Universität Bielefeld Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE) Germany (DE) Icahn School of Medicine at Mount Sinai United States (USA) (US) University College London (UCL) United Kingdom (GB) Foundation of the Carlo Besta Neurological Institute (IRCCS) Italy (IT) Maastricht University Medical Center (UMC+) Netherlands (NL) Goethe-Universität Frankfurt am Main Germany (DE) All India Institute of Medical Sciences India (IN) Ruhr-Universität Bochum (RUB) Germany (DE) Assistance Publique-Hôpitaux de Paris (AP-HP) France (FR) University of California, San Diego United States (USA) (US) University of California Irvine United States (USA) (US) Universidade Estadual de Campinas (UNICAMP) / University of Campinas Brazil (BR) Eberhard Karls Universität Tübingen Germany (DE) Evangelisches Krankenhaus Alsterdorf Germany (DE) University of Washington United States (USA) (US) Universitätsklinikum Aachen (UKA) Germany (DE) National Institute of Neurology and Neurosurgery / Instituto Nacional de Neurología y Neurocirugía (INNN) Mexico (MX) Universitätsklinikum Bonn Germany (DE) Royal Brisbane and Women's Hospital Australia (AU) The Walton Centre NHS Foundation Trust United Kingdom (GB) Medizinische Universität Wien Austria (AT) Charité - Universitätsmedizin Berlin Germany (DE) Krankenhaus Mara Germany (DE) Hôpital Pierre Wertheimer France (FR) University of Zurich / Universität Zürich (UZH) Switzerland (CH) Ospedale Niguarda Ca' Granda / ASST Grande Ospedale Metropolitano Niguarda Italy (IT)

How to cite

APA:

Drexler, R., Ben-Haim, S., Bien, C.G., Borger, V., Cardinale, F., Carpentier, A.,... Sauvigny, T. (2021). Enhancing Safety in Epilepsy Surgery (EASINESS): Study Protocol for a Retrospective, Multicenter, Open Registry. Frontiers in Neurology, 12. https://doi.org/10.3389/fneur.2021.782666

MLA:

Drexler, Richard, et al. "Enhancing Safety in Epilepsy Surgery (EASINESS): Study Protocol for a Retrospective, Multicenter, Open Registry." Frontiers in Neurology 12 (2021).

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