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

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

doi:10.3389/fneur.2021.782666

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

R. Drexler^*, S. Ben-Haim, C.G. Bien, V. Borger, F. Cardinale, A. Carpentier, F. Cendes, S. Chandra, H. Clusmann, A. Colon, M.D. Curtis, D. Delev, G. Didato, L. Duehrsen, J.O. Farah, M. Guenot, S. Ghatan, C. Haegelen, H. Hamer, J.S. HauptmannR.L. Jeffree, T. Kalbhenn, J. Kegele, N. Krayenbuehl, J.H.N. Lang, B. Mathon, G. Naros, J. Onken, F. Panov, C. Raftopoulos, F.L. Ricklefs, K. Rijkers, M. Rizzi, K. Roessler, O. Schijns, U.C. Schneider, A. Spyrantis, A. Strzelczyk, S. Stodieck, M. Tripathi, S. Vadera, M.A. Alonso-Vanegas, J.G.R. Vaz, J. Wellmer, T. Wehner, M. Westphal, T. Sauvigny

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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).

Original language	English
Article number	782666
Number of pages	6
Journal	Frontiers in Neurology
Volume	12
DOIs	https://doi.org/10.3389/fneur.2021.782666
Publication status	Published - 13 Dec 2021

Keywords

epilepsy
epilepsy surgery
temporal lobe epilepsy
outcome
benchmark
seizure outcome
amygdalohippocampectomy
anteromedial resection
DEFINING BENCHMARKS
QUALITY IMPROVEMENT
PROGRAM
CARE

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10.3389/fneur.2021.782666Licence: CC BY

Cite this

Drexler, R., Ben-Haim, S., Bien, C. G., Borger, V., Cardinale, F., Carpentier, A., Cendes, F., Chandra, S., Clusmann, H., Colon, A., Curtis, M. D., Delev, D., Didato, G., Duehrsen, L., Farah, J. O., Guenot, M., Ghatan, S., Haegelen, C., Hamer, H., ... Sauvigny, T. (2021). Enhancing Safety in Epilepsy Surgery (EASINESS): Study Protocol for a Retrospective, Multicenter, Open Registry. Frontiers in Neurology, 12, Article 782666. https://doi.org/10.3389/fneur.2021.782666

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title = "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).",

keywords = "epilepsy, epilepsy surgery, temporal lobe epilepsy, outcome, benchmark, seizure outcome, amygdalohippocampectomy, anteromedial resection, DEFINING BENCHMARKS, QUALITY IMPROVEMENT, PROGRAM, CARE",

author = "R. Drexler and S. Ben-Haim and C.G. Bien and V. Borger and F. Cardinale and A. Carpentier and F. Cendes and S. Chandra and H. Clusmann and A. Colon and M.D. Curtis and D. Delev and G. Didato and L. Duehrsen and J.O. Farah and M. Guenot and S. Ghatan and C. Haegelen and H. Hamer and J.S. Hauptmann and R.L. Jeffree and T. Kalbhenn and J. Kegele and N. Krayenbuehl and J.H.N. Lang and B. Mathon and G. Naros and J. Onken and F. Panov and C. Raftopoulos and F.L. Ricklefs and K. Rijkers and M. Rizzi and K. Roessler and O. Schijns and U.C. Schneider and A. Spyrantis and A. Strzelczyk and S. Stodieck and M. Tripathi and S. Vadera and M.A. Alonso-Vanegas and J.G.R. Vaz and J. Wellmer and T. Wehner and M. Westphal and T. Sauvigny",

note = "Publisher Copyright: Copyright {\textcopyright} 2021 Drexler, Ben-Haim, Bien, Borger, Cardinale, Carpentier, Cendes, Chandra, Clusmann, Colon, Curtis, Delev, Didato, D{\"u}hrsen, Farah, Guenot, Ghatan, Haegelen, Hamer, Hauptmann, Jeffree, Kalbhenn, Kegele, Krayenb{\"u}hl, Lang, Mathon, Naros, Onken, Panov, Raftopoulos, Ricklefs, Rijkers, Rizzi, R{\"o}ssler, Schijns, Schneider, Spyrantis, Strzelczyk, Stodieck, Tripathi, Vadera, Alonso-Vanegas, Vaz, Wellmer, Wehner, Westphal and Sauvigny.",

year = "2021",

month = dec,

day = "13",

doi = "10.3389/fneur.2021.782666",

language = "English",

volume = "12",

journal = "Frontiers in Neurology",

issn = "1664-2295",

publisher = "Frontiers Media S.A.",

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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, JHN, 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, 'Enhancing Safety in Epilepsy Surgery (EASINESS): Study Protocol for a Retrospective, Multicenter, Open Registry', Frontiers in Neurology, vol. 12, 782666. https://doi.org/10.3389/fneur.2021.782666

TY - JOUR

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

AU - Drexler, R.

AU - Ben-Haim, S.

AU - Bien, C.G.

AU - Borger, V.

AU - Cardinale, F.

AU - Carpentier, A.

AU - Cendes, F.

AU - Chandra, S.

AU - Clusmann, H.

AU - Colon, A.

AU - Curtis, M.D.

AU - Delev, D.

AU - Didato, G.

AU - Duehrsen, L.

AU - Farah, J.O.

AU - Guenot, M.

AU - Ghatan, S.

AU - Haegelen, C.

AU - Hamer, H.

AU - Hauptmann, J.S.

AU - Jeffree, R.L.

AU - Kalbhenn, T.

AU - Kegele, J.

AU - Krayenbuehl, N.

AU - Lang, J.H.N.

AU - Mathon, B.

AU - Naros, G.

AU - Onken, J.

AU - Panov, F.

AU - Raftopoulos, C.

AU - Ricklefs, F.L.

AU - Rijkers, K.

AU - Rizzi, M.

AU - Roessler, K.

AU - Schijns, O.

AU - Schneider, U.C.

AU - Spyrantis, A.

AU - Strzelczyk, A.

AU - Stodieck, S.

AU - Tripathi, M.

AU - Vadera, S.

AU - Alonso-Vanegas, M.A.

AU - Vaz, J.G.R.

AU - Wellmer, J.

AU - Wehner, T.

AU - Westphal, M.

AU - Sauvigny, T.

N1 - Publisher Copyright: 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).

KW - epilepsy

KW - epilepsy surgery

KW - temporal lobe epilepsy

KW - outcome

KW - benchmark

KW - seizure outcome

KW - amygdalohippocampectomy

KW - anteromedial resection

KW - DEFINING BENCHMARKS

KW - QUALITY IMPROVEMENT

KW - PROGRAM

KW - CARE

U2 - 10.3389/fneur.2021.782666

DO - 10.3389/fneur.2021.782666

M3 - Article

C2 - 34966349

SN - 1664-2295

VL - 12

JO - Frontiers in Neurology

JF - Frontiers in Neurology

M1 - 782666

ER -