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Completed

NCT Number: NCT01413802

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

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onze Lieve Vrouw clinic Aalst, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients (men/women) requiring thyroid surgery

Exclusion criteria

  • patients younger than 18 years, patients with preoperative vocal cord anatomical and functional anomalies.

Treatment and study plan

Continuous nerve monitoring

Procedure

Continuous nerve monitoring is performed during thyroid surgery.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: CoNeMoTS

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Aug 10, 2011
Registry last updated
Dec 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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