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

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

JOURNAL=Frontiers in Neurology

VOLUME=12

YEAR=2021

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.782666

DOI=10.3389/fneur.2021.782666

ISSN=1664-2295

ABSTRACT=<p><bold>Introduction:</bold> 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.</p><p><bold>Design:</bold> 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.</p><p><bold>Outcomes:</bold> 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.</p><p><bold>Discussion:</bold> 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.</p><p><bold>Clinical trial registration:</bold> This study is indexed at <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">clinicaltrials.gov</ext-link> (NT 04952298).</p>