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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 (CoNeMoTS)

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ClinicalTrials.gov Identifier: NCT01413802
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Ghent.
Recruitment status was:  Enrolling by invitation
First Posted : August 10, 2011
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Thyroid Surgery Procedure: Continuous nerve monitoring

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Thyroid
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01413802     History of Changes
Other Study ID Numbers: 2011/371
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by University Hospital, Ghent:
Thyroid surgery

Additional relevant MeSH terms:
Thyroid Diseases
Endocrine System Diseases