EASINESS-TRIAL - Enhancing Safety in Epilepsy Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Outcome Measures
Primary Outcome Measures
- 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)
- Figural memory [up to 1 year]
Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test
- Attention [up to 1-year]
Improvement, unchanged, deterioration, e.g. at the Wechsler Memory Scale
- Verbal memory [up to 1 year]
Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test
- Neurological deficit [up to 1 year]
None, visual field loss, diplopia, motor deficit, sensory deficit, language impairment (according to NANO scale)
- 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 [up to 1 year]
Not-visible or visible
- 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]
Other Outcome Measures
- Age [At time of surgery]
- Sex [At time of surgery]
- Education status [At time of surgery]
- American Society of Anaesthesiologists (ASA) physical status [At time of surgery]
1 (healthy person) to 6 (declared brain-dead person)
- Body mass index [At time of surgery]
in kg/m^2
- 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 [At time of surgery]
None, visual field loss, diplopia, motor deficit, sensory deficit, language impairment (according to NANO scale)
- Preoperative MRI lesion [At time of surgery]
- MRI post-processing conducted [At time of surgery]
- Additional preoperative diagnostic tool [At time of surgery]
PET, SPECT, MEG, Wada test
- Type of surgery [Surgery]
Selective amygdalohippocampectomy, anteromedial temporal lobe resection including amydalohippocampectomy, anterior temporal lobe resection
- Intraoperative navigation [Surgery]
No or yes
- Side of procedure [Surgery]
- Operating duration [Surgery]
minutes
- Histological finding [At time of surgery]
Hippocampal sclerosis, focal cortical dysplasia, dysembryoplastic neuroepithelial tumours, Ganglioglioma, others
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Medical Center Hamburg-Eppendorf | Hamburg | Germany | 20246 |
Sponsors and Collaborators
- Universitätsklinikum Hamburg-Eppendorf
- Charite University, Berlin, Germany
- University of Erlangen-Nürnberg
- University Clinic Frankfurt
- Vienna General Hospital
Investigators
- Principal Investigator: Richard Drexler, MD, Universitätsklinikum Hamburg-Eppendorf
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EASINESS