NCT04952298

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

July 7, 2021

Status Verified

June 1, 2021

Enrollment Period

5 years

First QC Date

June 11, 2021

Last Update Submit

June 26, 2021

Conditions

Epilepsy, Temporal LobeAmygdalo-Hippocampal Epilepsy

Outcome Measures

Primary Outcomes (15)

  • 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 Outcomes (24)

  • Age

    At time of surgery

  • Sex

    At time of surgery

  • Education status

    At time of surgery

  • +21 more other outcomes

Interventions

Mesial temporal lobe epilepsy surgeryPROCEDURE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Only neocortical temporal resection
  • Recurrent resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Epilepsy, Temporal LobeEpilepsies, Partial

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Study Officials

  • Richard Drexler, MD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Drexler, MD

CONTACT

+4915222816461r.drexler@uke.de

Thomas Sauvigny, MD

CONTACT

t.sauvigny@uke.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

June 11, 2021

First Posted

July 7, 2021

Study Start

January 1, 2015

Primary Completion

December 31, 2019

Study Completion

December 1, 2022

Last Updated

July 7, 2021

Record last verified: 2021-06

Locations

DE(1)