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

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

Sponsors

Lead Sponsor: Inha University Hospital

Source 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.

Overall Status Not yet recruiting
Start Date 2021-05-01
Completion Date 2022-05-30
Primary Completion Date 2022-04-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Voice Handicap Index - 30 (VHI-30) Preoperative 1 day
Voice Handicap Index - 30 (VHI-30) Postoperative 3 months
Voice Handicap Index - 30 (VHI-30) Postoperative 9 months
Secondary Outcome
Measure Time Frame
Voice range profile (VRP) Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.
GRBAS score Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.
Enrollment 80
Condition
Intervention

Intervention Type: Device

Intervention Name: Anti-adhesion barrier (Collarbarrier)

Description: Collagen derived anti-adhesion barrier

Arm Group Label: Treatment

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

Gender:

All

Minimum Age:

20 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Jin Wook Yi, Professor

Phone: +82-32-890-3437

Email: [email protected]

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Inha University Hospital

Investigator Full Name: Jin Wook Yi

Investigator Title: Assistant Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Treatment

Type: Experimental

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.

Label: Control

Type: No Intervention

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Treatment: Use of Anti-adhesion barrier on the thyroidectomy space Control: No use of anti-adhesion barrier

Primary Purpose: Treatment

Masking: Single (Participant)

Masking Description: Participants do not know about the use of anti-adhesion agents.

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