Effect of Anti-adhesion Barrier on the Voice Quality After Thyroidectomy.
Primary Purpose
Thyroid Nodule, Thyroid Cancer, Voice Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Anti-adhesion barrier (Collarbarrier)
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Nodule
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
Sites / Locations
- Inha University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm 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.
No use of anti-adhesion barrier. After the thyroidectomy, don't use the anti-adhesion barrier before the wound closure.
Outcomes
Primary Outcome Measures
Voice Handicap Index - 30 (VHI-30)
Overall score of VHI (Total 30 points)
Voice Handicap Index - 30 (VHI-30)
Overall score of VHI (Total 30 points)
Voice Handicap Index - 30 (VHI-30)
Overall score of VHI (Total 30 points)
Secondary Outcome Measures
Voice range profile (VRP)
Mininum Hz, Maximal Hz
GRBAS score
Grade, Rough, Breathy, Asthenic, Strained score. (0-3 points in each parameter)
Full Information
NCT ID
NCT04853680
First Posted
April 11, 2021
Last Updated
August 23, 2021
Sponsor
Inha University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04853680
Brief Title
Effect of Anti-adhesion Barrier on the Voice Quality After Thyroidectomy.
Official Title
A Prospective Randomized Controlled Study of Whether Anti-adhesion Barrier Can Prevent Voice Quality After Thyroidectomy.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inha University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule, Thyroid Cancer, Voice Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Treatment: Use of Anti-adhesion barrier on the thyroidectomy space Control: No use of anti-adhesion barrier
Masking
Participant
Masking Description
Participants do not know about the use of anti-adhesion agents.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No use of anti-adhesion barrier. After the thyroidectomy, don't use the anti-adhesion barrier before the wound closure.
Intervention Type
Device
Intervention Name(s)
Anti-adhesion barrier (Collarbarrier)
Intervention Description
Collagen derived anti-adhesion barrier
Primary Outcome Measure Information:
Title
Voice Handicap Index - 30 (VHI-30)
Description
Overall score of VHI (Total 30 points)
Time Frame
Preoperative 1 day
Title
Voice Handicap Index - 30 (VHI-30)
Description
Overall score of VHI (Total 30 points)
Time Frame
Postoperative 3 months
Title
Voice Handicap Index - 30 (VHI-30)
Description
Overall score of VHI (Total 30 points)
Time Frame
Postoperative 9 months
Secondary Outcome Measure Information:
Title
Voice range profile (VRP)
Description
Mininum Hz, Maximal Hz
Time Frame
Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.
Title
GRBAS score
Description
Grade, Rough, Breathy, Asthenic, Strained score. (0-3 points in each parameter)
Time Frame
Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Wook Yi, Professor
Phone
+82-32-890-3437
Email
jinwook.yi@inha.ac.kr
Facility Information:
Facility Name
Inha University Hospital
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Wook Yi, Dr.
Phone
+82-32-890-3437
Email
jinwook.yi@inha.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
In order to protect the privacy of patients, the original data of the study will not be disclosed.
Learn more about this trial
Effect of Anti-adhesion Barrier on the Voice Quality After Thyroidectomy.
We'll reach out to this number within 24 hrs