EASINESS-TRIAL - Enhancing Safety in Epilepsy Surgery

Epilepsy, Temporal Lobe Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04952298
• Other study ID #: EASINESS
• Status: Recruiting
• Start date: January 1, 2015
• Est. completion date: December 2022

Study information

• Verified date: June 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Richard Drexler, MD
• Phone: +4915222816461
• Email: r.drexler[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2022
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Epilepsy, Temporal Lobe

Intervention

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

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (5)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Charite University, Berlin, Germany, University Clinic Frankfurt, University of Erlangen-Nürnberg, Vienna General Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age		At time of surgery
Other	Sex		At time of surgery
Other	Education status		At time of surgery
Other	American Society of Anaesthesiologists (ASA) physical status	1 (healthy person) to 6 (declared brain-dead person)	At time of surgery
Other	Body mass index	in kg/m^2	At time of surgery
Other	History of neonatal seizures		At time of surgery
Other	History of febrile seizures		At time of surgery
Other	History of encephalitis or meningitis		At time of surgery
Other	Congestive heart failure		At time of surgery
Other	Coagulopathy / bleeding disorder		At time of surgery
Other	Diabetes mellitus		At time of surgery
Other	Age at epilepsy onset		At time of surgery
Other	Type of seizures		At time of surgery
Other	Average monthly frequency of seizures impairing awareness in year before surgery		At time of surgery
Other	Number of anticonvulsive drugs		At time of surgery
Other	Neurological deficit	None, visual field loss, diplopia, motor deficit, sensory deficit, language impairment (according to NANO scale)	At time of surgery
Other	Preoperative MRI lesion		At time of surgery
Other	MRI post-processing conducted		At time of surgery
Other	Additional preoperative diagnostic tool	PET, SPECT, MEG, Wada test	At time of surgery
Other	Type of surgery	Selective amygdalohippocampectomy, anteromedial temporal lobe resection including amydalohippocampectomy, anterior temporal lobe resection	Surgery
Other	Intraoperative navigation	No or yes	Surgery
Other	Side of procedure		Surgery
Other	Operating duration	minutes	Surgery
Other	Histological finding	Hippocampal sclerosis, focal cortical dysplasia, dysembryoplastic neuroepithelial tumours, Ganglioglioma, others	At time of surgery
Primary	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
Primary	Figural memory	Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test	up to 1 year
Primary	Attention	Improvement, unchanged, deterioration, e.g. at the Wechsler Memory Scale	up to 1-year
Primary	Verbal memory	Improvement, unchanged, deterioration, e.g. at the Rey Auditory-Verbal Learning Test	up to 1 year
Primary	Neurological deficit	None, visual field loss, diplopia, motor deficit, sensory deficit, language impairment (according to NANO scale)	up to 1 year
Primary	3D-Volumetry of extent of resection on MRI		3 months postoperatively
Primary	Number of anticonvulsive drugs		up to 1 year
Primary	Reoperation		up to 1 year
Primary	Temporalis muscle atrophy	Not-visible or visible	up to 1 year
Primary	Complication of any severity		up to 1 year
Primary	Stroke		up to 1 year
Primary	Surgical site infection		up to 1 year
Primary	In-hospital mortality after index surgery		up to 1 year
Primary	Length of ICU stay after index surgery		up to 1 year
Primary	Length of stay after index surgery		up to 1 year