Status:
UNKNOWN
Effect of Anti-adhesion Barrier on the Voice Quality After Thyroidectomy.
Lead Sponsor:
Inha University Hospital
Conditions:
Thyroid Nodule
Thyroid Cancer
Eligibility:
All Genders
20-70 years
Phase:
NA
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-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04853680
Start Date
July 1 2021
End Date
July 30 2023
Last Update
August 25 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Inha University Hospital
Incheon, South Korea, 22332