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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)

Primary Purpose

Thyroid Surgery

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Continuous nerve monitoring
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thyroid Surgery focused on measuring Thyroid surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 8, 2011
Last Updated
December 28, 2022
Sponsor
University Hospital, Ghent
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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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