An interventional study of Continuous nerve monitoring in Thyroid Surgery, sponsored by University Hospital, Ghent. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-29.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Prevention
During thyroid surgery the laryngeal recurrent nerves (and for this reason the voice quality) are at risk. Therefore intra operative continuous neuromonitoring could help to prevent harm to these nerves. Electromyographic data (EMG values) are collected during surgery (1). In the postoperative follow-up period detailed voice analysis is performed (2): subjective auditive perceptive evaluation and videostroboscopy. Analysis and comparison of (1) and (2) will be performed in order to find out if we can find a predictive correlation between the EMG data (1) and the voice quality (2).
University Hospital, Ghent is the lead sponsor of 685 studies on the registry; 158 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Exclusion Criteria:
Patients who undergo thyroid surgery during which intra operative continuous nerve monitoring will be used.
Procedure: Continuous nerve monitoring
Continuous nerve monitoring is performed during thyroid surgery.
Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery.
The primary outcome is to check if by continuous vagal nerve stimulation reversible damage to the recurrent laryngeal nerve can be foreseen, and therefore avoided. The detailed voice analysis that is used, consist of subjective auditive perceptive evaluation and videostroboscopy.
Time frame: 1 week after surgery
Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery.
The primary outcome is to check if by continuous vagal nerve stimulation reversible damage to the recurrent laryngeal nerve can be foreseen, and therefore avoided. The detailed voice analysis that is used, consist of subjective auditive perceptive evaluation and videostroboscopy.
Time frame: 3 weeks after surgery
Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery.
The primary outcome is to check if by continuous vagal nerve stimulation reversible damage to the recurrent laryngeal nerve can be foreseen, and therefore avoided. The detailed voice analysis that is used, consist of subjective auditive perceptive evaluation and videostroboscopy.
Time frame: 3 months after surgery
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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