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

Not Applicable

Completed

• Conditions: Thyroid Surgery
• Interventions: Procedure: Continuous nerve monitoring

• Registration Number: NCT01413802
• Lead Sponsor: University Hospital, Ghent

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Study Start: 2011-09-01
• Primary Completion: 2012-02-28
• Study Completion: 2013-03-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-28
• Last Update Posted: 2022-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients (men/women) requiring thyroid surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thyroid surgery.	Continuous nerve monitoring	Patients who undergo thyroid surgery during which intra operative continuous nerve monitoring will be used.

Primary Outcome Measures

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

Trial Locations

Locations (2)

University Hospital Ghent; 🇧🇪 Ghent, Belgium

Onze Lieve Vrouw clinic Aalst; 🇧🇪 Aalst, Belgium