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

Thyroid Surgery Clinical Trial

— CoNeMoTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413802
• Other study ID #: 2011/371
• Status: Completed
• Phase: N/A
• Start date: September 1, 2011
• Est. completion date: March 5, 2013

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 5, 2013
• Est. primary completion date: February 28, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients (men/women) requiring thyroid surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Surgery

Intervention

Procedure:
• Continuous nerve monitoring
Continuous nerve monitoring is performed during thyroid surgery.

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouw clinic Aalst	Aalst
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week after surgery
Primary	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.	3 weeks after surgery
Primary	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.	3 months after surgery

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