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

Thyroid Cancer Clinical Trial

Official title:

A Prospective Randomized Controlled Study of Whether Anti-adhesion Barrier Can Prevent Voice Quality After Thyroidectomy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04853680
• Other study ID #: 2020-12-023-001
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 30, 2023

Study information

• Verified date: August 2021
• Source: Inha University Hospital
• Contact: Jin Wook Yi, Professor
• Phone: +82-32-890-3437
• Email: jinwook.yi[@]inha.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Thyroid Nodule
• Voice Disorders

Intervention

Device:
• Anti-adhesion barrier (Collarbarrier)
Collagen derived anti-adhesion barrier

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Inha University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voice Handicap Index - 30 (VHI-30)	Overall score of VHI (Total 30 points)	Preoperative 1 day
Primary	Voice Handicap Index - 30 (VHI-30)	Overall score of VHI (Total 30 points)	Postoperative 3 months
Primary	Voice Handicap Index - 30 (VHI-30)	Overall score of VHI (Total 30 points)	Postoperative 9 months
Secondary	Voice range profile (VRP)	Mininum Hz, Maximal Hz	Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.
Secondary	GRBAS score	Grade, Rough, Breathy, Asthenic, Strained score. (0-3 points in each parameter)	Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.