EASINESS-TRIAL - Enhancing Safety in Epilepsy Surgery

U

Universitätsklinikum Hamburg-Eppendorf

Status

Unknown

Conditions

Epilepsy, Temporal Lobe
Amygdalo-Hippocampal Epilepsy

Treatments

Procedure: Mesial temporal lobe epilepsy surgery

Study type

Observational

Funder types

Other

Identifiers

NCT04952298
EASINESS

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,500 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

0

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Central trial contact

Thomas Sauvigny, MD; Richard Drexler, MD

Data sourced from clinicaltrials.gov

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