NCT04707053

Data Collection and Analysis in Brainstem Surgeries

Data Collection and Analysis of Neuroimaging and Intraoperative Neurophysiological Monitoring (IONM) in Brainstem Surgeries

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Cantonal Hospital of St. Gallen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Brainstem Lesion
• Surgery
• Intraoperative Neurophysiologic Monitoring

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2021-01-13
• Last updated: 2023-02-10

Locations

1 site across 1 country: Switzerland