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.

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

Study Overview

• Status: Recruiting
• Conditions: Thyroid Cancer; Thyroid Nodule; Voice Disorders
• Intervention / Treatment: Device: Anti-adhesion barrier (Collarbarrier)

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jin Wook Yi, Professor; Phone Number: +82-32-890-3437; Email: jinwook.yi@inha.ac.kr

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 22332
    • Recruiting
    • Inha University Hospital
    • Contact: Jin Wook Yi, Dr.; Phone Number: +82-32-890-3437; Email: jinwook.yi@inha.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment; 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.	Device: Anti-adhesion barrier (Collarbarrier); Collagen derived anti-adhesion barrier
NO_INTERVENTION: Control; No use of anti-adhesion barrier. After the thyroidectomy, don't use the anti-adhesion barrier before the wound closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voice Handicap Index - 30 (VHI-30)	Overall score of VHI (Total 30 points)	Preoperative 1 day
Voice Handicap Index - 30 (VHI-30)	Overall score of VHI (Total 30 points)	Postoperative 3 months
Voice Handicap Index - 30 (VHI-30)	Overall score of VHI (Total 30 points)	Postoperative 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voice range profile (VRP)	Mininum Hz, Maximal Hz	Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.
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.

Collaborators and Investigators

• Sponsor: Inha University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2021
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): July 30, 2023

Study Registration Dates

• First Submitted: April 11, 2021
• First Submitted That Met QC Criteria: April 18, 2021
• First Posted (ACTUAL): April 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Endocrine System Diseases; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Otorhinolaryngologic Diseases; Laryngeal Diseases; Thyroid Neoplasms; Thyroid Diseases; Thyroid Nodule; Voice Disorders
• Other Study ID Numbers: 2020-12-023-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In order to protect the privacy of patients, the original data of the study will not be disclosed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No