Effect of Anti-adhesion Barrier on the Voice Quality After Thyroidectomy.

Study Overview
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Brief Summary
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To determine whether the use of anti-adhesion barrier after thyroid surgery can prevent the voice changes after surgery, using objective voice-related indicators.

Detailed Description
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Randomized controlled study Including 40 patients in each arm Treatment: anti-adhesion barrier apply on the thyroidectomy space Control: No use of anti-adhesion barrier Primary outcome: VHI-30 (Voice handicap index) Secondary outcome: findings from stroboscopy, CSL (Computerize Speech Lab) Outcome measurement: preoperative, post-operative 3 months, post-operative 9 months.

Official Title
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A Prospective Randomized Controlled Study of Whether Anti-adhesion Barrier Can Prevent Voice Quality After Thyroidectomy.

Conditions
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Thyroid Nodule, Thyroid Cancer, Voice Disorders

Intervention / Treatment
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* Device: Anti-adhesion barrier (Collarbarrier)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing open thyroidectomy for thyroid cancer Patients whose tumor size is less than 4cm Patients who are not suspected of surrounding organ involvement (T4) or metastasis to central lymph nodes in preoperative imaging Patients with no history of voice-related diseases prior to surgery Patients with normal movement of both vocal cords in the preoperative vocal cord examination Patients who consented to the study and obtained consent for the study Exclusion Criteria: Patients with uncontrolled high blood pressure, diabetes, chronic renal failure, coagulation disease, etc. History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, cerebral infarction, cerebral hemorrhage, etc.) Medical history of drug or substance disorder (alcohol, etc.) Patients with diseases related to airways, esophagus, and vocal cords (vocal palsy, vocal cord polyps, etc.) Patients who have already had adhesions in the foreground due to radiation therapy or surgery on the foreground in the past. Patients with a history of keloid or hypertrophic scars Patients planning to perform lateral cervical lymph node dissection Patients with medical thyroid disease, such as Graves' disease and thyroid inflammation in need of treatment Pregnant or lactating female patients Other patients who are in charge of clinical trials as unsuitable for participation in the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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
Interventional Model Description: Treatment: Use of Anti-adhesion barrier on the thyroidectomy space Control: No use of anti-adhesion barrier
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Use of Anti-adhesion barrier on the thyroidectomy space. After the thyroidectomy, anti-adhesion barrier will be applied on the thyroidectomy space, around the trachea, cricothyroid muscle and platysma muscle before the closure of surgical wound. | Device: Anti-adhesion barrier (Collarbarrier)<br>* Collagen derived anti-adhesion barrier<br>|
| No Intervention: Control<br>No use of anti-adhesion barrier. After the thyroidectomy, don't use the anti-adhesion barrier before the wound closure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice Handicap Index - 30 (VHI-30) | Overall score of VHI (Total 30 points) | Preoperative 1 day | 
| Voice Handicap Index - 30 (VHI-30) | Overall score of VHI (Total 30 points) | Postoperative 3 months | 
| Voice Handicap Index - 30 (VHI-30) | Overall score of VHI (Total 30 points) | Postoperative 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice range profile (VRP) | Mininum Hz, Maximal Hz | Preoperative 1 day, Post-operative 3 months, Post-operative 9 months. | 
| GRBAS score | Grade, Rough, Breathy, Asthenic, Strained score. (0-3 points in each parameter) | Preoperative 1 day, Post-operative 3 months, Post-operative 9 months. |