NCT04952298

EASINESS-TRIAL - Enhancing Safety in Epilepsy Surgery

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Epilepsy, Temporal Lobe
• Amygdalo-Hippocampal Epilepsy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-12-31
• Completion: 2022-12-01
• First posted: 2021-07-07
• Last updated: 2021-07-07

Locations

1 site across 1 country: Germany