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Clinical Trials/NCT01413802
NCT01413802
Completed
N/A

Intra Operative Continuous Laryngeal Nerve Monitoring During Thyroid Surgery and Interpretation of the Post-operative Voice Quality in Relation to the Electromyography Data Obtained During Surgery

University Hospital, Ghent2 sites in 1 country100 target enrollmentSeptember 1, 2011
ConditionsThyroid Surgery

Overview

Phase
N/A
Intervention
Not specified
Conditions
Thyroid Surgery
Sponsor
University Hospital, Ghent
Enrollment
100
Locations
2
Primary Endpoint
Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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).

Registry
clinicaltrials.gov
Start Date
September 1, 2011
End Date
March 5, 2013
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patients (men/women) requiring thyroid surgery

Exclusion Criteria

  • patients younger than 18 years, patients with preoperative vocal cord anatomical and functional anomalies.

Outcomes

Primary Outcomes

Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery.

Time Frame: 3 months after 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.

Study Sites (2)

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