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

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).

Defining benchmark outcomes for mesial temporal lobe epilepsy surgery: A global multicenter analysis of 1119 cases

“…In a multicenter, retrospective cohort study based on institutional databases, we included consecutive patients who underwent MTLE surgery between 2015 and 2019. As previously described, 19 participating centers needed to perform 30 or more epilepsy‐specific surgeries (not limited to MTLE surgery) on average per year during the 5‐year study period. This threshold is based on and adapted from the German Society for Epileptology recommendations and the Austrian, German, and Swiss working groups on presurgical epilepsy diagnosis and operative epilepsy treatment for certification as an epilepsy center performing epilepsy surgery 20,21 .…”