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 (CoNeMoTS)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01413802
First received: August 8, 2011
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention
Thyroid Surgery
Procedure: Continuous nerve monitoring

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery. [ Time Frame: 1 week after surgery ] [ Designated as safety issue: Yes ]
    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.

  • Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery. [ Time Frame: 3 weeks after surgery ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thyroid surgery.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413802

Locations
Belgium
Onze Lieve Vrouw clinic Aalst
Aalst, Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Hubert Vermeersch, MD Phd University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01413802     History of Changes
Other Study ID Numbers: 2011/371
Study First Received: August 8, 2011
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
Thyroid surgery

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014