Clinical trial NCT04853680: Effect of Anti-adhesion Barrier on the Voice Quality After Thyroidectomy.
Official title: A Prospective Randomized Controlled Study of Whether Anti-adhesion Barrier Can Prevent Voice Quality After Thyroidectomy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Nodule
Thyroid Cancer
Voice Disorders
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Treatment: Use of Anti-adhesion barrier on the thyroidectomy space Control: No use of anti-adhesion barrier
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Voice Handicap Index - 30 (VHI-30)
timeFrame: Preoperative 1 day
measure: Voice Handicap Index - 30 (VHI-30)
timeFrame: Postoperative 3 months
measure: Voice Handicap Index - 30 (VHI-30)
timeFrame: Postoperative 9 months
Secondary outcomes:
measure: Voice range profile (VRP)
timeFrame: Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.
measure: GRBAS score
timeFrame: Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
Study officials:
References: