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

TY - JOUR

T1 - Enhancing Safety in Epilepsy Surgery (EASINESS): Study Protocol for a Retrospective, Multicenter, Open Registry

AU - Drexler, Richard

AU - Ben-Haim, Sharona

AU - Bien, Christian G

AU - Borger, Valeri

AU - Cardinale, Francesco

AU - Carpentier, Alexandre

AU - Cendes, Fernando

AU - Chandra, Sarat

AU - Clusmann, Hans

AU - Colon, Albert

AU - de Curtis, Marco

AU - Delev, Daniel

AU - Didato, Giuseppe

AU - Dührsen, Lasse

AU - Farah, Jibril Osman

AU - Guenot, Marc

AU - Ghatan, Saadi

AU - Haegelen, Claire

AU - Hamer, Hajo

AU - Hauptmann, Jason S

AU - Jeffree, Rosalind L

AU - Kalbhenn, Thilo

AU - Kegele, Josua

AU - Krayenbühl, Niklaus

AU - Lang, Johannes

AU - Mathon, Bertrand

AU - Naros, Georgios

AU - Onken, Julia

AU - Panov, Fedor

AU - Raftopoulos, Christian

AU - Ricklefs, Franz L

AU - Rijkers, Kim

AU - Rizzi, Michele

AU - Rössler, Karl

AU - Schijns, Olaf

AU - Schneider, Ulf C

AU - Spyrantis, Andrea

AU - Strzelczyk, Adam

AU - Stodieck, Stefan

AU - Tripathi, Manjari

AU - Vadera, Sumeet

AU - Alonso-Vanegas, Mario A

AU - Vaz, José Géraldo Ribero

AU - Wellmer, Jörg

AU - Wehner, Tim

AU - Westphal, Manfred

AU - Sauvigny, Thomas

N1 - 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.

PY - 2021/12/13

Y1 - 2021/12/13

N2 - 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).

AB - 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).

U2 - 10.3389/fneur.2021.782666

DO - 10.3389/fneur.2021.782666

M3 - SCORING: Journal article

C2 - 34966349

VL - 12

JO - FRONT NEUROL

JF - FRONT NEUROL

SN - 1664-2295

M1 - 782666

ER -