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临床试验/NCT04952298
NCT04952298Unknown不适用

EASINESS-TRIAL - An Analysis of Standardized Outcome References From an International Multicentre Cohort

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2015年1月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Drexler

Resident

Universitätsklinikum Hamburg-Eppendorf

研究点 (1)

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