EASINESS-TRIAL - Enhancing Safety in Epilepsy Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2022-12-31

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.

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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.

Conditions

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Epilepsy, Temporal Lobe Amygdalo-Hippocampal Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

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