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EASINESS-TRIAL - Enhancing Safety in Epilepsy Surgery

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ClinicalTrials.gov Identifier: NCT04952298
Recruitment Status : Recruiting
First Posted : July 7, 2021
Last Update Posted : July 7, 2021
Sponsor:
Collaborators:
Charite University, Berlin, Germany
University of Erlangen-Nürnberg
University Clinic Frankfurt
Vienna General Hospital
Information provided by (Responsible Party):
Richard Drexler, Universitätsklinikum Hamburg-Eppendorf

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.

Condition or disease Intervention/treatment
Epilepsy, Temporal Lobe Amygdalo-Hippocampal Epilepsy 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.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: EASINESS-TRIAL - An Analysis of Standardized Outcome References From an International Multicentre Cohort
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy


Intervention Details:
  • Procedure: Mesial temporal lobe epilepsy 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


Primary Outcome Measures :
  1. 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)


  2. Figural memory [ Time Frame: up to 1 year ]
    Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test

  3. Attention [ Time Frame: up to 1-year ]
    Improvement, unchanged, deterioration, e.g. at the Wechsler Memory Scale

  4. Verbal memory [ Time Frame: up to 1 year ]
    Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test

  5. Neurological deficit [ Time Frame: up to 1 year ]
    None, visual field loss, diplopia, motor deficit, sensory deficit, language impairment (according to NANO scale)

  6. 3D-Volumetry of extent of resection on MRI [ Time Frame: 3 months postoperatively ]
  7. Number of anticonvulsive drugs [ Time Frame: up to 1 year ]
  8. Reoperation [ Time Frame: up to 1 year ]
  9. Temporalis muscle atrophy [ Time Frame: up to 1 year ]
    Not-visible or visible

  10. Complication of any severity [ Time Frame: up to 1 year ]
  11. Stroke [ Time Frame: up to 1 year ]
  12. Surgical site infection [ Time Frame: up to 1 year ]
  13. In-hospital mortality after index surgery [ Time Frame: up to 1 year ]
  14. Length of ICU stay after index surgery [ Time Frame: up to 1 year ]
  15. Length of stay after index surgery [ Time Frame: up to 1 year ]

Other Outcome Measures:
  1. Age [ Time Frame: At time of surgery ]
  2. Sex [ Time Frame: At time of surgery ]
  3. Education status [ Time Frame: At time of surgery ]
  4. American Society of Anaesthesiologists (ASA) physical status [ Time Frame: At time of surgery ]
    1 (healthy person) to 6 (declared brain-dead person)

  5. Body mass index [ Time Frame: At time of surgery ]
    in kg/m^2

  6. History of neonatal seizures [ Time Frame: At time of surgery ]
  7. History of febrile seizures [ Time Frame: At time of surgery ]
  8. History of encephalitis or meningitis [ Time Frame: At time of surgery ]
  9. Congestive heart failure [ Time Frame: At time of surgery ]
  10. Coagulopathy / bleeding disorder [ Time Frame: At time of surgery ]
  11. Diabetes mellitus [ Time Frame: At time of surgery ]
  12. Age at epilepsy onset [ Time Frame: At time of surgery ]
  13. Type of seizures [ Time Frame: At time of surgery ]
  14. Average monthly frequency of seizures impairing awareness in year before surgery [ Time Frame: At time of surgery ]
  15. Number of anticonvulsive drugs [ Time Frame: At time of surgery ]
  16. Neurological deficit [ Time Frame: At time of surgery ]
    None, visual field loss, diplopia, motor deficit, sensory deficit, language impairment (according to NANO scale)

  17. Preoperative MRI lesion [ Time Frame: At time of surgery ]
  18. MRI post-processing conducted [ Time Frame: At time of surgery ]
  19. Additional preoperative diagnostic tool [ Time Frame: At time of surgery ]
    PET, SPECT, MEG, Wada test

  20. Type of surgery [ Time Frame: Surgery ]
    Selective amygdalohippocampectomy, anteromedial temporal lobe resection including amydalohippocampectomy, anterior temporal lobe resection

  21. Intraoperative navigation [ Time Frame: Surgery ]
    No or yes

  22. Side of procedure [ Time Frame: Surgery ]
  23. Operating duration [ Time Frame: Surgery ]
    minutes

  24. Histological finding [ Time Frame: At time of surgery ]
    Hippocampal sclerosis, focal cortical dysplasia, dysembryoplastic neuroepithelial tumours, Ganglioglioma, others



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who went through medial temporal lobe epilepsy surgery at high-volume centres
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04952298


Contacts
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Contact: Richard Drexler, MD +4915222816461 r.drexler@uke.de
Contact: Thomas Sauvigny, MD t.sauvigny@uke.de

Locations
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Germany
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Richard Drexler, MD    +4915222816461    r.drexler@uke.de   
Principal Investigator: Richard Drexler, MD         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Charite University, Berlin, Germany
University of Erlangen-Nürnberg
University Clinic Frankfurt
Vienna General Hospital
Investigators
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Principal Investigator: Richard Drexler, MD Universitätsklinikum Hamburg-Eppendorf
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Responsible Party: Richard Drexler, Resident, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04952298    
Other Study ID Numbers: EASINESS
First Posted: July 7, 2021    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Epilepsy, Temporal Lobe
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epileptic Syndromes