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

August 8, 2011
February 1, 2013
September 2011
February 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01413802 on ClinicalTrials.gov Archive Site
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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
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

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).

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Thyroid Surgery
Procedure: Continuous nerve monitoring
Continuous nerve monitoring is performed during thyroid surgery.
Experimental: Thyroid surgery.
Patients who undergo thyroid surgery during which intra operative continuous nerve monitoring will be used.
Intervention: Procedure: Continuous nerve monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
100
May 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients (men/women) requiring thyroid surgery

Exclusion Criteria:

  • patients younger than 18 years, patients with preoperative vocal cord anatomical and functional anomalies.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01413802
2011/371
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Hubert Vermeersch, MD Phd University Hospital, Ghent
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP