EASINESS-TRIAL - Enhancing Safety in Epilepsy Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy, Temporal Lobe; Amygdalo-Hippocampal Epilepsy
• Intervention / Treatment: Procedure: Mesial temporal lobe epilepsy surgery

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 Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Thomas Sauvigny, MD; Email: t.sauvigny@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • University Medical Center Hamburg-Eppendorf
    • Principal Investigator: Richard Drexler, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who went through medial temporal lobe epilepsy surgery at high-volume centres

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age		At time of surgery
Operating duration	minutes	Surgery
Sex		At time of surgery
Education status		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
Histological finding	Hippocampal sclerosis, focal cortical dysplasia, dysembryoplastic neuroepithelial tumours, Ganglioglioma, others	At time of surgery

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Charite University, Berlin, Germany; University of Erlangen-Nürnberg; Vienna General Hospital; University Clinic Frankfurt

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 26, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: June 26, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Epilepsy; Epilepsies, Partial; Epilepsy, Temporal Lobe
• Other Study ID Numbers: EASINESS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No