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

Inha University Hospital

Status: Unknown

Conditions: Thyroid Nodule; Voice Disorders; Thyroid Cancer

Treatments: Device: Anti-adhesion barrier (Collarbarrier)

Study type: Interventional

Funder types: Other

Identifiers

NCT04853680

2020-12-023-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Treatment

Experimental group

Description:

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.

Treatment:

Device: Anti-adhesion barrier (Collarbarrier)

Control

No Intervention group

Description:

No use of anti-adhesion barrier. After the thyroidectomy, don't use the anti-adhesion barrier before the wound closure.