EASINESS-TRIAL - Enhancing Safety in Epilepsy Surgery

• Conditions: Epilepsy, Temporal Lobe; Amygdalo-Hippocampal Epilepsy

• Registration Number: NCT04952298
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2019-12-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-26
• Last Update Submitted: 2021-06-26
• Study First Posted: 2021-07-07
• Last Update Posted: 2021-07-07
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany