Data Collection and Analysis in Brainstem Surgeries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Brainstem Lesion Surgery Intraoperative Neurophysiologic Monitoring

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Intraaxial lesion group

Patients with intraaxial brainstem lesions (lesions located in the brainstem) + experienced brainstem surgery in our department during the study period

No interventions assigned to this group

Extraaxial lesion group

Patients with extraaxial brainstem lesions (lesions close to the brainstem) + experienced brainstem surgery in our department during the study period

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients age 18 - 80 years' old
* With lesions in or near the brainstem
* Patients who are suitable for brainstem surgery
* Patients who accept the surgery
* Patients who signed the informed consent

Exclusion Criteria

* Patients age \< 18 years
* Patients who are not suitable for brainstem surgery (for example patients in coma, very small lesion, pregnancy)
* Patients unlikely to attend the follow-up 12 months after surgery

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No