Thyroid SurgeryCoNeMoTSNCT01413802
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
A study testing Continuous nerve monitoring in people with Thyroid Surgery, run by University Hospital, Ghent at 2 sites in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Surgery
- What is being tested?
- Continuous nerve monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Sep 2011to 5 Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients (men/women) requiring thyroid surgery
Who cannot join
- patients younger than 18 years, patients with preoperative vocal cord anatomical and functional anomalies.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Onze Lieve Vrouw clinic Aalst
Aalst
University Hospital Ghent
Ghent, 9000
About this study
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).
- Conditions
- Thyroid Surgery
- Being tested
- Continuous nerve monitoring
- Keywords
- Thyroid surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous nerve monitoringProcedure or surgery
Continuous nerve monitoring is performed during thyroid surgery.
| Study group | Role | What they receive |
|---|---|---|
| Thyroid surgery. | Experimental | Patients who undergo thyroid surgery during which intra operative continuous nerve monitoring will be used. Receives: Procedure: Continuous nerve monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week after surgery
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.
Measured: 3 weeks after surgery
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.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study start1 Sep 2011
- Primary completion28 Feb 2012
- Study completion5 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert Vermeersch, MD Phd, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413802
- Sponsor's protocol ID
- 2011/371
- Acronym
- CoNeMoTS
- Status last verified
- Dec 2022
- First submitted
- 8 Aug 2011
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01413802
- Acronym / sponsor ID
- CoNeMoTS / 2011/371
- Conditions
- Thyroid Surgery
- Keywords
- Thyroid surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 28 Feb 2012 (actual)
- Study completion
- 5 Mar 2013 (actual)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thyroid surgery. | Experimental | Procedure: Continuous nerve monitoringPatients who undergo thyroid surgery during which intra operative continuous nerve monitoring will be used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients (men/women) requiring thyroid surgery
Key exclusion criteria (1 listed)
- patients younger than 18 years, patients with preoperative vocal cord anatomical and functional anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous nerve monitoringContinuous nerve monitoring is performed during thyroid surgery. | Procedure or surgery | Thyroid surgery. |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert Vermeersch, MD Phd principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous nerve monitoring in people with Thyroid Surgery, run by University Hospital, Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.