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.
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 Type
OBSERVATIONAL
Enrollment
1,500
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
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGSeizure Outcome
International League Against Epilepsy (ILAE) Outcome Scale \- Class 1 (seizure-free) to class 6 (\>100% increase of baseline seizure days)
Time frame: up to 1 year
Figural memory
Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test
Time frame: up to 1 year
Attention
Improvement, unchanged, deterioration, e.g. at the Wechsler Memory Scale
Time frame: up to 1-year
Verbal memory
Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test
Time frame: up to 1 year
Neurological deficit
None, visual field loss, diplopia, motor deficit, sensory deficit, language impairment (according to NANO scale)
Time frame: up to 1 year
3D-Volumetry of extent of resection on MRI
Time frame: 3 months postoperatively
Number of anticonvulsive drugs
Time frame: up to 1 year
Reoperation
Time frame: up to 1 year
Temporalis muscle atrophy
Not-visible or visible
Time frame: up to 1 year
Complication of any severity
Time frame: up to 1 year
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Stroke
Time frame: up to 1 year
Surgical site infection
Time frame: up to 1 year
In-hospital mortality after index surgery
Time frame: up to 1 year
Length of ICU stay after index surgery
Time frame: up to 1 year
Length of stay after index surgery
Time frame: up to 1 year