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

NCT04853680 | Unknown

• 1 other identifier: 2020-12-023-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Nodule; Thyroid Cancer; Voice Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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.

Study Arms (2)

Treatment

EXPERIMENTAL

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)

Control

NO INTERVENTION

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

Interventions

Anti-adhesion barrier (Collarbarrier) DEVICE

Collagen derived anti-adhesion barrier

Treatment

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inha University Hospital: lead

Study Sites (1)

Inha University Hospital

Incheon, 22332, South Korea

RECRUITING

MeSH Terms

Conditions

Thyroid Nodule; Thyroid Neoplasms; Voice Disorders

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jin Wook Yi, Professor

CONTACT

+82-32-890-3437; jinwook.yi@inha.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants do not know about the use of anti-adhesion agents.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 21, 2021
• Study Start: July 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: July 30, 2023
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)