EASINESS-TRIAL - An Analysis of Standardized Outcome References From an International Multicentre Cohort
试验速览
- 阶段
- 不适用
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Only neocortical temporal resection
- •Recurrent resection
结局指标
主要结局
Surgical site infection
时间窗: up to 1 year
Verbal memory
时间窗: up to 1 year
Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test
3D-Volumetry of extent of resection on MRI
时间窗: 3 months postoperatively
Number of anticonvulsive drugs
时间窗: up to 1 year
Stroke
时间窗: up to 1 year
In-hospital mortality after index surgery
时间窗: up to 1 year
Length of stay after index surgery
时间窗: up to 1 year
Figural memory
时间窗: up to 1 year
Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test
Seizure Outcome
时间窗: 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
时间窗: up to 1 year
Attention
时间窗: up to 1-year
Improvement, unchanged, deterioration, e.g. at the Wechsler Memory Scale
Neurological deficit
时间窗: up to 1 year
None, visual field loss, diplopia, motor deficit, sensory deficit, language impairment (according to NANO scale)
Reoperation
时间窗: up to 1 year
Temporalis muscle atrophy
时间窗: up to 1 year
Not-visible or visible
Length of ICU stay after index surgery
时间窗: up to 1 year
次要结局
未报告次要终点
研究者
Richard Drexler
Resident
Universitätsklinikum Hamburg-Eppendorf
