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:
University Hospital, Ghent
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
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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:
MedlinePlus related topics:
Thyroid Diseases
Drug Information available for:
Thyroid
U.S. FDA Resources
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 May 19, 2013