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ID
Source
Brief title
Health condition
Epilepsy
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is change in disease specific quality of life (expressed in points change at the QOLIE-31 questionnaire).
Secondary outcome
Secondary outcomes are change in general quality of life (expressed in points change at the EQ-5D questionnaire), seizure frequency (ILAE-classification), use of care (iMCQ), productivity (iPCQ), the correlation between change in quality of life and seizure reduction. Also, based on these outcomes, an economic evaluation will be performed.
Background summary
Epilepsy is one of the most common neurological diseases and is characterized by epileptic seizures. An epileptic seizure is an episodic event that is caused by excessive paroxysmal electric discharges of brain cells. Epilepsy is associated with a diminished quality of life. The standard treatment is with anti-epileptic drugs. About 40% of the patients does not achieve satisfying results with anti-epileptic drugs, they suffer from drug-resistant epilepsy. For some of these patients resective epilepsy surgery, where the part of the brain where the abnormal discharging brain cells are located, is surgically removed, can be an effective treatment, resulting in seizure freedom or significant reduction of seizure frequency. Seizure reduction is one of the most important determinants of quality of life for epilepsy patients.
The objective of the RESQUE-study is to evaluate the change in quality of life of drug-resistant epilepsy patients during 2 years after epilepsy surgery. Also, data with respect to seizure frequency, seizure severity, side effects, use of medicale care (anti-epileptic drugs, number of visits to the emergency department, neurology consults, hospital admittance) and productivity (ability to work, social functioning) will be collected. The data will used to conduct an economic evaluation of resective epilepsy surgery.
Study objective
The hypothesis is that drug-resistant epilepsy patients will report a significant increase in quality of life 1 and 2 years after resective epilepsy surgery. The study is a prospective cohort study. The study population consists of adult drug-resistant epilepsy patients that receive resective epilepsy surgery in the Maastricht UMC+ and the Amsterdam UMC (location VU) in the period of September 2020 until September 2021. Patients will fill out validated questionnairs on baseline and 3-6-12-24 months after surgery.
Study design
inclusion 01-09-2020
Inclusion criteria
Included will be patients that are selected for surgery between September 2019 and September 2021 in the Maastricht UMC+ and Amsterdam UMC.
Exclusion criteria
Excluded will be patients who do not speak Dutch or patients who are considered mentally deficient (TIQ below 70), because they are expected not to be able to fill out the questionnaires. With a disharmonic level of intelligence the verbal IQ (<70) is leading.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8278 |
| Other | METC MUMC+ : METC 2019-1134 |