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

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ClinicalTrials.gov Identifier: NCT04853680
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Jin Wook Yi, Inha University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Thyroid Nodule Thyroid Cancer Voice Disorders Device: Anti-adhesion barrier (Collarbarrier) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Masking: Single (Participant)
Masking Description: Participants do not know about the use of anti-adhesion agents.
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Study of Whether Anti-adhesion Barrier Can Prevent Voice Quality After Thyroidectomy.
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Voice Handicap Index - 30 (VHI-30) [ Time Frame: Preoperative 1 day ]
    Overall score of VHI (Total 30 points)

  2. Voice Handicap Index - 30 (VHI-30) [ Time Frame: Postoperative 3 months ]
    Overall score of VHI (Total 30 points)

  3. Voice Handicap Index - 30 (VHI-30) [ Time Frame: Postoperative 9 months ]
    Overall score of VHI (Total 30 points)


Secondary Outcome Measures :
  1. Voice range profile (VRP) [ Time Frame: Preoperative 1 day, Post-operative 3 months, Post-operative 9 months. ]
    Mininum Hz, Maximal Hz

  2. GRBAS score [ Time Frame: Preoperative 1 day, Post-operative 3 months, Post-operative 9 months. ]
    Grade, Rough, Breathy, Asthenic, Strained score. (0-3 points in each parameter)


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853680


Contacts
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Contact: Jin Wook Yi, Professor +82-32-890-3437 jinwook.yi@inha.ac.kr

Locations
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Korea, Republic of
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 22332
Contact: Jin Wook Yi, Dr.    +82-32-890-3437    jinwook.yi@inha.ac.kr   
Sponsors and Collaborators
Inha University Hospital
More Information
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Responsible Party: Jin Wook Yi, Assistant Professor, Inha University Hospital
ClinicalTrials.gov Identifier: NCT04853680    
Other Study ID Numbers: 2020-12-023-001
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: In order to protect the privacy of patients, the original data of the study will not be disclosed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Nodule
Voice Disorders
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
 Neoplasms
Head and Neck Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases