Epilepsy, Temporal LobeNCT04952298
EASINESS-TRIAL - Enhancing Safety in Epilepsy Surgery
An observational study of Epilepsy, Temporal Lobe and Amygdalo-Hippocampal Epilepsy, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy, Temporal Lobe, Amygdalo-Hippocampal Epilepsy
- What is being tested?
- Mesial temporal lobe epilepsy surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2015to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who went through medial temporal lobe epilepsy surgery at high-volume centres
Who may be able to join
- 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
Who cannot join
- Only neocortical temporal resection
- Recurrent resection
Trial locations and contacts
1 site in 1 country.
Thomas Sauvigny, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Richard Drexler, MD, +4915222816461, r.drexler@uke.de
Richard Drexler, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Mesial temporal lobe epilepsy surgery
- Medical subject headings
- Epilepsy, Temporal Lobe, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesial temporal lobe epilepsy surgeryProcedure or surgery
Medial temporal lobe epilepsy surgery including
- selective Amygdalohippocempectomy (SAH) including anterior parahippocampal gyrus / entorhinal cortex
- anteromedial temporal lobe resection including amygdalohippocampectomy
- anterior temporal lobe resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Outcome
International League Against Epilepsy (ILAE) Outcome Scale
- Class 1 (seizure-free) to class 6 (>100% increase of baseline seizure days)
Measured: up to 1 year
Figural memory
Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test
Measured: up to 1 year
Attention
Improvement, unchanged, deterioration, e.g. at the Wechsler Memory Scale
Measured: up to 1-year
Verbal memory
Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test
Measured: up to 1 year
Neurological deficit
None, visual field loss, diplopia, motor deficit, sensory deficit, language impairment (according to NANO scale)
Measured: up to 1 year
3D-Volumetry of extent of resection on MRI
Measured: 3 months postoperatively
Number of anticonvulsive drugs
Measured: up to 1 year
Reoperation
Measured: up to 1 year
Temporalis muscle atrophy
Not-visible or visible
Measured: up to 1 year
Complication of any severity
Measured: up to 1 year
Stroke
Measured: up to 1 year
Surgical site infection
Measured: up to 1 year
In-hospital mortality after index surgery
Measured: up to 1 year
Length of ICU stay after index surgery
Measured: up to 1 year
Length of stay after index surgery
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start1 Jan 2015
- Primary completion31 Dec 2019
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Temporal LobeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University of Erlangen-Nürnberg, University Clinic Frankfurt, Vienna General Hospital
- Responsible party
- Principal investigator, Richard Drexler, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Richard Drexler, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952298
- Sponsor's protocol ID
- EASINESS
- Status last verified
- Jun 2021
- First submitted
- 11 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EASINESS-TRIAL - An Analysis of Standardized Outcome References From an International Multicentre Cohort
- ClinicalTrials.gov ID
- NCT04952298
- Acronym / sponsor ID
- EASINESS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University of Erlangen-Nürnberg, University Clinic Frankfurt, Vienna General Hospital
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- Dec 2022 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who went through medial temporal lobe epilepsy surgery at high-volume centres
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Only neocortical temporal resection
- Recurrent resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesial temporal lobe epilepsy surgeryMedial temporal lobe epilepsy surgery including * selective Amygdalohippocempectomy (SAH) including anterior parahippocampal gyrus / entorhinal cortex * anteromedial temporal lobe resection including amygdalohippocampectomy * anterior temporal lobe resection | Procedure or surgery | – |
Primary outcome
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)
Figural memory
Time frame: up to 1 year
Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test
Attention
Time frame: up to 1-year
Improvement, unchanged, deterioration, e.g. at the Wechsler Memory Scale
Verbal memory
Time frame: up to 1 year
Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test
Neurological deficit
Time frame: up to 1 year
None, visual field loss, diplopia, motor deficit, sensory deficit, language impairment (according to NANO scale)
3D-Volumetry of extent of resection on MRI
Time frame: 3 months postoperatively
Number of anticonvulsive drugs
Time frame: up to 1 year
Reoperation
Time frame: up to 1 year
Temporalis muscle atrophy
Time frame: up to 1 year
Not-visible or visible
Complication of any severity
Time frame: up to 1 year
Stroke
Time frame: up to 1 year
Surgical site infection
Time frame: up to 1 year
In-hospital mortality after index surgery
Time frame: up to 1 year
Length of ICU stay after index surgery
Time frame: up to 1 year
Length of stay after index surgery
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Epilepsy, Temporal Lobe
RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
RecruitingObservational study
Investigating Epilepsy: Screening and Evaluation
Seizures, Epilepsy
RecruitingObservational study
Surgery as a Treatment for Medically Intractable Epilepsy
Epilepsy, Epilepsy, Temporal Lobe
Recruiting
Overnight TI in TLE
Temporal Lobe Epilepsy (TLE), Drug Resistant Epilepsy
RecruitingEarly Phase 1
Pharmacological Modulation of Brain Oscillations in Memory Processing
Epilepsy, Seizures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Sauvigny, MD contact
Richard Drexler, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, Temporal Lobe and Amygdalo-Hippocampal Epilepsy, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Drexler, MD (+4915222816461, r.drexler@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure Outcome (time frame: up to 1 year). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.