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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Control | No Intervention | No use of anti-adhesion barrier. After the thyroidectomy, don't use the anti-adhesion barrier before the wound closure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-adhesion barrier (Collarbarrier) | Device | Collagen derived anti-adhesion barrier |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Wook Yi, Professor | Contact | +82-32-890-3437 | jinwook.yi@inha.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inha University Hospital | Recruiting | Incheon | 22332 | South Korea |
In order to protect the privacy of patients, the original data of the study will not be disclosed.
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| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| D013964 | Thyroid Neoplasms |
| D014832 | Voice Disorders |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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Treatment: Use of Anti-adhesion barrier on the thyroidectomy space Control: No use of anti-adhesion barrier
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Participants do not know about the use of anti-adhesion agents.
| Preoperative 1 day, Post-operative 3 months, Post-operative 9 months. |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |