Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery

Study Overview
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Brief Summary
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Effect of intraoperative nerve monitoring on voice quality during thyroid surgery Thyroidectomy is a quite often surgical procedure applied by both head and neck surgeons and endocrine surgeons.Recent advances in surgical and technological area achieve a remarkable decrease in the complication rates. In case of these advances, patients still have fear related with their voice. In this study, investigators aimed to investigate voice changes during thyroid surgery and effect of intraoperative nerve monitoring to the voice quality.

Detailed Description
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In order to minimize the complication rates and voice disturbances during thyroidectomy, intraoperative nerve monitoring(IONM) is a widely used intervention. In this study investigators will compare conventional surgery with IONM used surgery. Randomly chosen half of the patients will be operated with IONM. Vagus, recurrent and superior laryngeal nerves will be monitored during surgery and measured for nerve integrity . Rest of the patients will be operated with standard conventional method. All participants will be analyzed with a computer program for their voice quality preoperatively and postoperatively at 14th day of surgery.

Official Title
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Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery

Conditions
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Thyroid

Intervention / Treatment
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* Procedure: Intraoperative nerve monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and radiological diagnosis of nodular or multinodular goiter Clinical, radiological and pathologically diagnosed thyroid cancer Must be able to speak (for voice recording) Exclusion Criteria: Pregnancy Previous thyroid surgery Previous laryngeal operations Professional voice users (e.g. singers)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Conventional group<br>Standard conventional thyroid surgery | |
| Active Comparator: IONM group<br>Intraoperative nerve monitoring used thyroid surgery | Procedure: Intraoperative nerve monitoring<br>* Intraoperative nerve monitoring during thyroid surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice analysis | Comparison of Jitter(microseconds) and Shimmer(dB) values of recorded voices | up to 2nd week voice recording | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Comparison of differences in operation time period between the groups whether IONM used or not | duration of surgery, up to 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroidectomy, nerve monitoring