Data Collection and Analysis in Brainstem Surgeries
Study Details
Study Description
Brief Summary
The hypothesis is that the structural documentation and analysis of the data of demographics, neuroimaging, IONM and clinical outcomes can help to further standardize the use of such equipment for detecting the integrity of the corticospinal tracts.
We want to confirm that the retrospectively data analysis of neuroimaging, IONM and clinical outcomes does help to understand these methods better in the surgical management of brainstem lesions, and therefore, improve the safety of brainstem surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This will be a prospective data collection and retrospective data analysis study to investigate the effect of pre- and post-neuroimaging, intraoperative monitoring, and clinical outcome during the surgical management of brainstem lesions in our neurosurgical center. The data of demographics, neuroimaging, IONM and patients' outcomes will be acquired based on the medical records and follow-up visits. All data is stored in the personal file of the clinical information system for each patient. The expected duration of each subject's participation is confined to the surgery itself and the routine visits during the follow-up. The overall study duration is expected to collect all the brainstem surgery in next five years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Intraaxial lesion group Patients with intraaxial brainstem lesions (lesions located in the brainstem) + experienced brainstem surgery in our department during the study period |
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| Extraaxial lesion group Patients with extraaxial brainstem lesions (lesions close to the brainstem) + experienced brainstem surgery in our department during the study period |
Outcome Measures
Primary Outcome Measures
- Data of direct brainstem stimulation and clinical outcome [09/2020-12/2021]
The measurement of stimulation intensity (in mA) and its corresponding neurophysiological outcome (positive or not), as well as the short- and long-term neurological outcome (mRS 0-6) help the standardization of direct brainstem stimulation and clinical outcome prediction
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients age 18 - 80 years' old
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With lesions in or near the brainstem
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Patients who are suitable for brainstem surgery
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Patients who accept the surgery
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Patients who signed the informed consent
Exclusion Criteria:
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Patients age < 18 years
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Patients who are not suitable for brainstem surgery (for example patients in coma, very small lesion, pregnancy)
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Patients unlikely to attend the follow-up 12 months after surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kantonsspital St.Gallen | St. Gallen | Switzerland | 9000 |
Sponsors and Collaborators
- Cantonal Hospital of St. Gallen
Investigators
- Study Chair: Oliver Bozinov, Prof, Cantonal Hospital of St. Gallen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-02088