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| Name | Class |
|---|---|
| Charite University, Berlin, Germany | OTHER |
| University of Erlangen-Nürnberg | OTHER |
| University Clinic Frankfurt | OTHER |
| Vienna General Hospital |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesial temporal lobe epilepsy surgery | Procedure | Medial temporal lobe epilepsy surgery including
|
| Measure | Description | Time Frame |
|---|---|---|
| Seizure Outcome | International League Against Epilepsy (ILAE) Outcome Scale - Class 1 (seizure-free) to class 6 (>100% increase of baseline seizure days) | up to 1 year |
| Figural memory | Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test | up to 1 year |
| Attention | Improvement, unchanged, deterioration, e.g. at the Wechsler Memory Scale | up to 1-year |
| Verbal memory | Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test | up to 1 year |
| Neurological deficit | None, visual field loss, diplopia, motor deficit, sensory deficit, language impairment (according to NANO scale) | up to 1 year |
| 3D-Volumetry of extent of resection on MRI | 3 months postoperatively | |
| Number of anticonvulsive drugs | up to 1 year | |
| Reoperation | up to 1 year | |
| Temporalis muscle atrophy | Not-visible or visible |
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| Measure | Description | Time Frame |
|---|---|---|
| Age | At time of surgery | |
| Sex | At time of surgery | |
| Education status |
Inclusion Criteria:
Exclusion Criteria:
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Patients who went through medial temporal lobe epilepsy surgery at high-volume centres
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard Drexler, MD | Contact | +4915222816461 | r.drexler@uke.de | |
| Thomas Sauvigny, MD | Contact | t.sauvigny@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Richard Drexler, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
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| ID | Term |
|---|---|
| D004833 | Epilepsy, Temporal Lobe |
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
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| up to 1 year |
| Complication of any severity | up to 1 year |
| Stroke | up to 1 year |
| Surgical site infection | up to 1 year |
| In-hospital mortality after index surgery | up to 1 year |
| Length of ICU stay after index surgery | up to 1 year |
| Length of stay after index surgery | up to 1 year |
| At time of surgery |
| American Society of Anaesthesiologists (ASA) physical status | 1 (healthy person) to 6 (declared brain-dead person) | At time of surgery |
| Body mass index | in kg/m^2 | At time of surgery |
| History of neonatal seizures | At time of surgery |
| History of febrile seizures | At time of surgery |
| History of encephalitis or meningitis | At time of surgery |
| Congestive heart failure | At time of surgery |
| Coagulopathy / bleeding disorder | At time of surgery |
| Diabetes mellitus | At time of surgery |
| Age at epilepsy onset | At time of surgery |
| Type of seizures | At time of surgery |
| Average monthly frequency of seizures impairing awareness in year before surgery | At time of surgery |
| Number of anticonvulsive drugs | At time of surgery |
| Neurological deficit | None, visual field loss, diplopia, motor deficit, sensory deficit, language impairment (according to NANO scale) | At time of surgery |
| Preoperative MRI lesion | At time of surgery |
| MRI post-processing conducted | At time of surgery |
| Additional preoperative diagnostic tool | PET, SPECT, MEG, Wada test | At time of surgery |
| Type of surgery | Selective amygdalohippocampectomy, anteromedial temporal lobe resection including amydalohippocampectomy, anterior temporal lobe resection | Surgery |
| Intraoperative navigation | No or yes | Surgery |
| Side of procedure | Surgery |
| Operating duration | minutes | Surgery |
| Histological finding | Hippocampal sclerosis, focal cortical dysplasia, dysembryoplastic neuroepithelial tumours, Ganglioglioma, others | At time of surgery |
| D000073376 |
| Epileptic Syndromes |