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)
Primary Purpose
Thyroid Surgery
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Continuous nerve monitoring
Sponsored by
About this trial
This is an interventional prevention trial for Thyroid Surgery focused on measuring Thyroid surgery
Eligibility 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.
Sites / Locations
- Onze Lieve Vrouw clinic Aalst
- University Hospital Ghent
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thyroid surgery.
Arm Description
Patients who undergo thyroid surgery during which intra operative continuous nerve monitoring will be used.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01413802
First Posted
August 8, 2011
Last Updated
December 28, 2022
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT01413802
Brief 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
Acronym
CoNeMoTS
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 Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2011 (Actual)
Primary Completion Date
February 28, 2012 (Actual)
Study Completion Date
March 5, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Surgery
Keywords
Thyroid surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thyroid surgery.
Arm Type
Experimental
Arm Description
Patients who undergo thyroid surgery during which intra operative continuous nerve monitoring will be used.
Intervention Type
Procedure
Intervention Name(s)
Continuous nerve monitoring
Intervention Description
Continuous nerve monitoring is performed during thyroid surgery.
Primary Outcome Measure Information:
Title
Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery.
Description
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.
Time Frame
1 week after surgery
Title
Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery.
Description
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.
Time Frame
3 weeks after surgery
Title
Detailed voice analysis to find a predictive correlation between the EMG data and the voice quality, after thyroid surgery.
Description
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.
Time Frame
3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert Vermeersch, MD Phd
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onze Lieve Vrouw clinic Aalst
City
Aalst
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Related Info
Learn more about this trial
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
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