EASINESS-TRIAL - Enhancing Safety in Epilepsy Surgery

  • STATUS
    Recruiting
  • End date
    Dec 16, 2022
  • participants needed
    1500
  • sponsor
    Universitätsklinikum Hamburg-Eppendorf
Updated on 16 July 2021

Summary

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.

Description

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.

Details
Condition Temporal lobe epilepsy, Focal epilepsy
Treatment Mesial temporal lobe epilepsy surgery
Clinical Study IdentifierNCT04952298
SponsorUniversitätsklinikum Hamburg-Eppendorf
Last Modified on16 July 2021

Eligibility

Yes No Not Sure

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
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