Evaluation of neurosurgical resection strategies in temporal lobe epilepsy
| ISRCTN | ISRCTN50562632 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50562632 |
| Protocol serial number | N/A |
| Sponsor | German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) |
| Funder | German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany) |
- Submission date
- 11/08/2008
- Registration date
- 21/08/2008
- Last edited
- 28/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Sigmund-Freud-Str. 25
Bonn
53105
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, interventional, randomised multicentre study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Prospective and randomised multicentre trial investigating the pros and cons of different extent of mesial resection in surgery for mesial temporal lobe epilepsy |
| Study objectives | There is an ongoing debate about the mesial resection extent in the surgical treatment of temporal lobe (TL) epilepsy patients and its relation to seizure freedom and neuropsychological outcome. Surgical resection strategies developed from larger resections removing up to 2/3 of the temporal lobe to more selective and smaller resection types. The objective of this study is to assess the significance of the extent of resection of mesial structures (hippocampus and parahippocampus) to achieve seizure freedom after surgery for temporal lobe epilepsy. The main goals of this project are to test two hypotheses: 1. Smaller TL resections are associated with less neuropsychological deterioration 2. Post-operative seizure freedom is comparably good in smaller mesial resection |
| Ethics approval(s) | Ethics approval received from the Ethics Committee of the University of Bonn Medical Centre on the 2nd February 2001 (ref: 237/00) |
| Health condition(s) or problem(s) studied | Intractable mesial temporal lobe epilepsy (MTLE) |
| Intervention | As part of the presurgical evaluation patients underwent neuropsychological testing and MRI scanning. Healthy volunteers also underwent neuropsychological testing to serve as a control group regarding the cognitive abilities of the patients. Patients were randomised to either a short (2.5 cm of hippocampal resection) or a long (3.5 resection length) resection group. The length of resection was to be determined intra-operatively after the opening of the temporal horn by using millimetre paper from the anterior tip of the temporal horn backwards placed on the hippocampal head along its length axis. Furthermore, manual volumetry of structural MRI datasets was used to evaluate the intended resection length. Post-operatively, patients are seen for MRI-scanning, neuropsychological testing and medical consultation 3, 6 and 12 months after surgery. |
| Intervention type | Other |
| Primary outcome measure(s) |
Seizure freedom at one year after surgery: defined as class I in the Engel Outcome Scale. The Engel Outcome Scale is administered post-operatively and determines the improvement/worsening after surgical intervention as follows: |
| Key secondary outcome measure(s) |
Neuropsychological testing: |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 250 |
| Key inclusion criteria | 1. Patients suffering from intractable temporal lobe epilepsy 2. Drug resistance: seizure history lasting more than two years 3. Pre-surgical evaluation led to the recommendation of either a partial temporal lobe resection combined with amygdalohippocampectomy or a more restricted selected selective amygdalohippocampectomy (SAH) 4. Only cases with mesial involvement were included 5. Patients had to be at least 18 years old (either sex) and able to understand the study plan 6. Written informed consent |
| Key exclusion criteria | 1. Previous temporal lobe surgery 2. Inability to do undergo neuropsychological testing because of retardation or foreign language 3. Mesial resection restricted to uncus and amygdala 4. No usable pre-operative magnetic resonance imaging (MRI) for volumetrical analyses 5. Pathology not allowing for randomisation (far dorsal reaching resection necessary) |
| Date of first enrolment | 15/10/2002 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
53105
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Cortical damage results (): | 01/02/2004 | Yes | No | |
| Results article | Neuropsychological outcome results (): | 01/07/2004 | Yes | No | |
| Results article | One year follow-up results (): | 01/08/2004 | Yes | No | |
| Results article | Children and aduly comparative study results (): | 01/12/2005 | Yes | No | |
| Results article | MRI volumetry results (): | 01/03/2007 | Yes | No | |
| Results article | Memory and non-memory function results (): | 01/01/2008 | Yes | No | |
| Results article | Cognitive rehabilitation results (): | 01/04/2008 | Yes | No | |
| Results article | Prospective study results (): | 01/08/2008 | Yes | No | |
| Other publications | Research (): | 01/12/2007 | Yes | No | |
| Other publications | Comment (): | 01/02/2008 | Yes | No | |
| Other publications | Review (): | 01/08/2008 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |