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

  • Richard Drexler
  • Sharona Ben-Haim
  • Christian G Bien
  • Valeri Borger
  • Francesco Cardinale
  • Alexandre Carpentier
  • Fernando Cendes
  • Sarat Chandra
  • Hans Clusmann
  • Albert Colon
  • Marco de Curtis
  • Daniel Delev
  • Giuseppe Didato
  • Lasse Dührsen
  • Jibril Osman Farah
  • Marc Guenot
  • Saadi Ghatan
  • Claire Haegelen
  • Hajo Hamer
  • Jason S Hauptmann
  • Rosalind L Jeffree
  • Thilo Kalbhenn
  • Josua Kegele
  • Niklaus Krayenbühl
  • Johannes Lang
  • Bertrand Mathon
  • Georgios Naros
  • Julia Onken
  • Fedor Panov
  • Christian Raftopoulos
  • Franz L Ricklefs
  • Kim Rijkers
  • Michele Rizzi
  • Karl Rössler
  • Olaf Schijns
  • Ulf C Schneider
  • Andrea Spyrantis
  • Adam Strzelczyk
  • Stefan Stodieck
  • Manjari Tripathi
  • Sumeet Vadera
  • Mario A Alonso-Vanegas
  • José Géraldo Ribero Vaz
  • Jörg Wellmer
  • Tim Wehner
  • Manfred Westphal
  • Thomas Sauvigny

Beteiligte Einrichtungen

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).

Bibliografische Daten

OriginalspracheEnglisch
Aufsatznummer782666
ISSN1664-2295
DOIs
StatusVeröffentlicht - 13.12.2021

Anmerkungen des Dekanats

Copyright © 2021 Drexler, Ben-Haim, Bien, Borger, Cardinale, Carpentier, Cendes, Chandra, Clusmann, Colon, Curtis, Delev, Didato, Dührsen, Farah, Guenot, Ghatan, Haegelen, Hamer, Hauptmann, Jeffree, Kalbhenn, Kegele, Krayenbühl, Lang, Mathon, Naros, Onken, Panov, Raftopoulos, Ricklefs, Rijkers, Rizzi, Rössler, Schijns, Schneider, Spyrantis, Strzelczyk, Stodieck, Tripathi, Vadera, Alonso-Vanegas, Vaz, Wellmer, Wehner, Westphal and Sauvigny.

PubMed 34966349