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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

NCT ID: NCT01413802

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-01

Study Completion Date

2013-03-05

Brief Summary

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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).

Detailed Description

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Conditions

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Thyroid Surgery

Keywords

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Thyroid surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Thyroid surgery.

Patients who undergo thyroid surgery during which intra operative continuous nerve monitoring will be used.

Group Type EXPERIMENTAL

Continuous nerve monitoring

Intervention Type PROCEDURE

Continuous nerve monitoring is performed during thyroid surgery.

Interventions

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Continuous nerve monitoring

Continuous nerve monitoring is performed during thyroid surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients (men/women) requiring thyroid surgery

Exclusion Criteria

* patients younger than 18 years, patients with preoperative vocal cord anatomical and functional anomalies.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hubert Vermeersch, MD Phd

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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Onze Lieve Vrouw clinic Aalst

Aalst, , Belgium

Site Status

University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Related Info

Other Identifiers

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2011/371

Identifier Type: -

Identifier Source: org_study_id