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

NCT01413802 | Completed

• 1 other identifier: 2011/371
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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).

Conditions

Thyroid Surgery

Keywords

Thyroid surgery

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Thyroid surgery.

EXPERIMENTAL

Patients who undergo thyroid surgery during which intra operative continuous nerve monitoring will be used.

Procedure: Continuous nerve monitoring

Interventions

Continuous nerve monitoring PROCEDURE

Continuous nerve monitoring is performed during thyroid surgery.

Thyroid surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients (men/women) requiring thyroid surgery

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (2)

Onze Lieve Vrouw clinic Aalst

Aalst, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

• Related Info

Study Officials

• Hubert Vermeersch, MD Phd

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: August 10, 2011
• Study Start: September 1, 2011
• Primary Completion: February 28, 2012
• Study Completion: March 5, 2013
• Last Updated: December 29, 2022

Record last verified: 2022-12

Locations

BE (2)