EASINESS-TRIAL - Enhancing Safety in Epilepsy Surgery

Study Overview
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Brief Summary
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To conduct a retrospective multicenter cohort study to define surgical benchmark values for best achievable outcomes following surgery for mesial temporal lobe epilepsy. Established benchmark serve as reference values for the evaluation of future surgical strategies and approaches.

Detailed Description
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Surgeons strive for the best possible outcome of their surgeries with the greatest possible chance for recovery of the patients. Therefore, monitoring and quality improvement is increasingly important in surgery. For this purpose, different concepts were developed with the aim to assess best achievable results for several surgical procedures and reduce unwarranted variation between different centers. The most common used concept in surgery is a combination of various clinical indicators with a focus on treatment and adverse events which offers a more reliable analysis than single-outcome indicators. The concept of a benchmark establishes reference values which represents the best possible outcome of high-volume centers and can be used for comparison and improvement. Benchmark values are established within a patients' cohort for which the best possible outcome can be expected. The aim of our study is the establishment of robust and standardized outcome references after amygdalohippocampectomy for temporal lobe epilepsy. After successful implantation of benchmarks from an international cohort of renowned centers, these data serve as reference values for the evaluation of novel surgical techniques and comparisons among centers or future clinical trials.

Official Title
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EASINESS-TRIAL - An Analysis of Standardized Outcome References From an International Multicentre Cohort

Conditions
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Epilepsy, Temporal Lobe, Amygdalo-Hippocampal Epilepsy

Intervention / Treatment
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* Procedure: Mesial temporal lobe epilepsy surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Centres with ≥30 seizure-specific resections (excluding vagus nerve stimulation) as an average per year during the 5-year study period Patients who went through mesial temporal lobe epilepsy surgery Exclusion Criteria: Only neocortical temporal resection Recurrent resection
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Mesial temporal lobe epilepsy surgery|Medial temporal lobe epilepsy surgery including selective Amygdalohippocempectomy (SAH) including anterior parahippocampal gyrus / entorhinal cortex anteromedial temporal lobe resection including amygdalohippocampectomy anterior temporal lobe resection|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure Outcome | International League Against Epilepsy (ILAE) Outcome Scale - Class 1 (seizure-free) to class 6 (>100% increase of baseline seizure days) | up to 1 year | 
| Figural memory | Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test | up to 1 year | 
| Attention | Improvement, unchanged, deterioration, e.g. at the Wechsler Memory Scale | up to 1-year | 
| Verbal memory | Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test | up to 1 year | 
| Neurological deficit | None, visual field loss, diplopia, motor deficit, sensory deficit, language impairment (according to NANO scale) | up to 1 year | 
| 3D-Volumetry of extent of resection on MRI |  | 3 months postoperatively | 
| Number of anticonvulsive drugs |  | up to 1 year | 
| Reoperation |  | up to 1 year | 
| Temporalis muscle atrophy | Not-visible or visible | up to 1 year | 
| Complication of any severity |  | up to 1 year | 
| Stroke |  | up to 1 year | 
| Surgical site infection |  | up to 1 year | 
| In-hospital mortality after index surgery |  | up to 1 year | 
| Length of ICU stay after index surgery |  | up to 1 year | 
| Length of stay after index surgery |  | up to 1 year |