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

Not Applicable

• Conditions: Thyroid Cancer; Voice Disorders; Thyroid Nodule

• Registration Number: NCT04853680
• Lead Sponsor: Inha University Hospital

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.

Study Timeline

• Study First Submitted: 2021-04-11
• Study First Submitted QC: 2021-04-18
• Study First Posted: 2021-04-21
• Study Start: 2021-07-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-25
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Voice Handicap Index - 30 (VHI-30)	Postoperative 9 months	Overall score of VHI (Total 30 points)

Secondary Outcome Measures

Name	Time	Method
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)
Voice range profile (VRP)	Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.	Mininum Hz, Maximal Hz

Trial Locations

Locations (1)

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of