Thyroid Cancer, Thyroid Nodule, Voice Disorders
Conditions
Brief summary
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
* 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.
Interventions
DEVICEAnti-adhesion barrier (Collarbarrier)
Collagen derived anti-adhesion barrier
Sponsors
Inha University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants do not know about the use of anti-adhesion agents.
Intervention model description
Treatment: Use of Anti-adhesion barrier on the thyroidectomy space Control: No use of anti-adhesion barrier
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Voice Handicap Index - 30 (VHI-30) | Preoperative 1 day | Overall score of VHI (Total 30 points) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voice range profile (VRP) | Preoperative 1 day, Post-operative 3 months, Post-operative 9 months. | Mininum Hz, Maximal Hz |
| GRBAS score | Preoperative 1 day, Post-operative 3 months, Post-operative 9 months. | Grade, Rough, Breathy, Asthenic, Strained score. (0-3 points in each parameter) |
Countries
South Korea
Contacts
Primary ContactJin Wook Yi, Professor
Outcome results
None listed