EASINESS-TRIAL - Enhancing Safety in Epilepsy Surgery

June 26, 2021 updated by: Richard Drexler, Universitätsklinikum Hamburg-Eppendorf

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Seizure Outcome
Time Frame: up to 1 year

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
Time Frame: up to 1 year
Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test
up to 1 year
Attention
Time Frame: up to 1-year
Improvement, unchanged, deterioration, e.g. at the Wechsler Memory Scale
up to 1-year
Verbal memory
Time Frame: up to 1 year
Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test
up to 1 year
Neurological deficit
Time Frame: up to 1 year
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
Time Frame: 3 months postoperatively
3 months postoperatively
Number of anticonvulsive drugs
Time Frame: up to 1 year
up to 1 year
Reoperation
Time Frame: up to 1 year
up to 1 year
Temporalis muscle atrophy
Time Frame: up to 1 year
Not-visible or visible
up to 1 year
Complication of any severity
Time Frame: up to 1 year
up to 1 year
Stroke
Time Frame: up to 1 year
up to 1 year
Surgical site infection
Time Frame: up to 1 year
up to 1 year
In-hospital mortality after index surgery
Time Frame: up to 1 year
up to 1 year
Length of ICU stay after index surgery
Time Frame: up to 1 year
up to 1 year
Length of stay after index surgery
Time Frame: up to 1 year
up to 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age
Time Frame: At time of surgery
At time of surgery
Operating duration
Time Frame: Surgery
minutes
Surgery
Sex
Time Frame: At time of surgery
At time of surgery
Education status
Time Frame: At time of surgery
At time of surgery
American Society of Anaesthesiologists (ASA) physical status
Time Frame: At time of surgery
1 (healthy person) to 6 (declared brain-dead person)
At time of surgery
Body mass index
Time Frame: At time of surgery
in kg/m^2
At time of surgery
History of neonatal seizures
Time Frame: At time of surgery
At time of surgery
History of febrile seizures
Time Frame: At time of surgery
At time of surgery
History of encephalitis or meningitis
Time Frame: At time of surgery
At time of surgery
Congestive heart failure
Time Frame: At time of surgery
At time of surgery
Coagulopathy / bleeding disorder
Time Frame: At time of surgery
At time of surgery
Diabetes mellitus
Time Frame: At time of surgery
At time of surgery
Age at epilepsy onset
Time Frame: At time of surgery
At time of surgery
Type of seizures
Time Frame: At time of surgery
At time of surgery
Average monthly frequency of seizures impairing awareness in year before surgery
Time Frame: At time of surgery
At time of surgery
Number of anticonvulsive drugs
Time Frame: At time of surgery
At time of surgery
Neurological deficit
Time Frame: At time of surgery
None, visual field loss, diplopia, motor deficit, sensory deficit, language impairment (according to NANO scale)
At time of surgery
Preoperative MRI lesion
Time Frame: At time of surgery
At time of surgery
MRI post-processing conducted
Time Frame: At time of surgery
At time of surgery
Additional preoperative diagnostic tool
Time Frame: At time of surgery
PET, SPECT, MEG, Wada test
At time of surgery
Type of surgery
Time Frame: Surgery
Selective amygdalohippocampectomy, anteromedial temporal lobe resection including amydalohippocampectomy, anterior temporal lobe resection
Surgery
Intraoperative navigation
Time Frame: Surgery
No or yes
Surgery
Side of procedure
Time Frame: Surgery
Surgery
Histological finding
Time Frame: At time of surgery
Hippocampal sclerosis, focal cortical dysplasia, dysembryoplastic neuroepithelial tumours, Ganglioglioma, others
At time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charite University, Berlin, Germany
University of Erlangen-Nürnberg
Vienna General Hospital
University Clinic Frankfurt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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