Clinical trial NCT04952298: EASINESS-TRIAL - Enhancing Safety in Epilepsy Surgery
Official title: EASINESS-TRIAL - An Analysis of Standardized Outcome References From an International Multicentre Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy, Temporal Lobe
Amygdalo-Hippocampal Epilepsy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: University of Erlangen-Nürnberg
name: University Clinic Frankfurt
name: Vienna General Hospital
First posted: 2021-07-07
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who went through medial temporal lobe epilepsy surgery at high-volume centres

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.

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.

Eligibility 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

Primary outcomes:
measure: Seizure Outcome
timeFrame: up to 1 year
measure: Figural memory
timeFrame: up to 1 year
measure: Attention
timeFrame: up to 1-year
measure: Verbal memory
timeFrame: up to 1 year
measure: Neurological deficit
timeFrame: up to 1 year
measure: 3D-Volumetry of extent of resection on MRI
timeFrame: 3 months postoperatively
measure: Number of anticonvulsive drugs
timeFrame: up to 1 year
measure: Reoperation
timeFrame: up to 1 year
measure: Temporalis muscle atrophy
timeFrame: up to 1 year
measure: Complication of any severity
timeFrame: up to 1 year
measure: Stroke
timeFrame: up to 1 year
measure: Surgical site infection
timeFrame: up to 1 year
measure: In-hospital mortality after index surgery
timeFrame: up to 1 year
measure: Length of ICU stay after index surgery
timeFrame: up to 1 year
measure: Length of stay after index surgery
timeFrame: up to 1 year
Secondary outcomes:
Other outcomes:
measure: Age
timeFrame: At time of surgery
measure: Sex
timeFrame: At time of surgery
measure: Education status
timeFrame: At time of surgery
measure: American Society of Anaesthesiologists (ASA) physical status
timeFrame: At time of surgery
measure: Body mass index
timeFrame: At time of surgery
measure: History of neonatal seizures
timeFrame: At time of surgery
measure: History of febrile seizures
timeFrame: At time of surgery
measure: History of encephalitis or meningitis
timeFrame: At time of surgery
measure: Congestive heart failure
timeFrame: At time of surgery
measure: Coagulopathy / bleeding disorder
timeFrame: At time of surgery
measure: Diabetes mellitus
timeFrame: At time of surgery
measure: Age at epilepsy onset
timeFrame: At time of surgery
measure: Type of seizures
timeFrame: At time of surgery
measure: Average monthly frequency of seizures impairing awareness in year before surgery
timeFrame: At time of surgery
measure: Number of anticonvulsive drugs
timeFrame: At time of surgery
measure: Neurological deficit
timeFrame: At time of surgery
measure: Preoperative MRI lesion
timeFrame: At time of surgery
measure: MRI post-processing conducted
timeFrame: At time of surgery
measure: Additional preoperative diagnostic tool
timeFrame: At time of surgery
measure: Type of surgery
timeFrame: Surgery
measure: Intraoperative navigation
timeFrame: Surgery
measure: Side of procedure
timeFrame: Surgery
measure: Operating duration
timeFrame: Surgery
measure: Histological finding
timeFrame: At time of surgery
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Richard Drexler, MD
role: PRINCIPAL_INVESTIGATOR
References: