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

Not Applicable

• Conditions: Thyroid Cancer; Voice Disorders; Thyroid Nodule
• Interventions: Device: Anti-adhesion barrier (Collarbarrier)

• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Anti-adhesion barrier (Collarbarrier)	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.

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