Thyroid NoduleNCT04853680
Effect of Anti-adhesion Barrier on the Voice Quality After Thyroidectomy.
A study testing Anti-adhesion barrier (Collarbarrier) in people with Thyroid Nodule and Thyroid Cancer, run by Inha University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Thyroid Nodule, Thyroid Cancer, Voice Disorders
- What is being tested?
- Anti-adhesion barrier (Collarbarrier)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2021to 30 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Inha University Hospital
Incheon, 22332
Jin Wook Yi, Dr., +82-32-890-3437, jinwook.yi@inha.ac.kr
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Nodule, Thyroid Cancer, Voice Disorders
- Being tested
- Anti-adhesion barrier (Collarbarrier)
- Medical subject headings
- Thyroid Nodule, Thyroid Neoplasms, Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-adhesion barrier (Collarbarrier)Device
Collagen derived anti-adhesion barrier
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voice Handicap Index - 30 (VHI-30)
Overall score of VHI (Total 30 points)
Measured: Preoperative 1 day
Voice Handicap Index - 30 (VHI-30)
Overall score of VHI (Total 30 points)
Measured: Postoperative 3 months
Voice Handicap Index - 30 (VHI-30)
Overall score of VHI (Total 30 points)
Measured: Postoperative 9 months
Secondary outcomes (2)
Voice range profile (VRP)
Mininum Hz, Maximal Hz
Measured: 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)
Measured: Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment: Use of Anti-adhesion barrier on the thyroidectomy space Control: No use of anti-adhesion barrier
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Wook Yi, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853680
- Sponsor's protocol ID
- 2020-12-023-001
- Status last verified
- Aug 2021
- First submitted
- 11 Apr 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In order to protect the privacy of patients, the original data of the study will not be disclosed.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study of Whether Anti-adhesion Barrier Can Prevent Voice Quality After Thyroidectomy.
- ClinicalTrials.gov ID
- NCT04853680
- Acronym / sponsor ID
- 2020-12-023-001
- Conditions
- Thyroid Nodule, Thyroid Cancer, Voice Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Treatment: Use of Anti-adhesion barrier on the thyroidectomy space Control: No use of anti-adhesion barrier
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Anti-adhesion barrier (Collarbarrier)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. |
| Control | No intervention | –No use of anti-adhesion barrier. After the thyroidectomy, don't use the anti-adhesion barrier before the wound closure. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-adhesion barrier (Collarbarrier)Collagen derived anti-adhesion barrier | Device | Treatment |
Primary outcome
Voice Handicap Index - 30 (VHI-30)
Time frame: Preoperative 1 day
Overall score of VHI (Total 30 points)
Voice Handicap Index - 30 (VHI-30)
Time frame: Postoperative 3 months
Overall score of VHI (Total 30 points)
Voice Handicap Index - 30 (VHI-30)
Time frame: Postoperative 9 months
Overall score of VHI (Total 30 points)
2 secondary outcomes
Voice range profile (VRP)
Time frame: Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.
GRBAS score
Time frame: Preoperative 1 day, Post-operative 3 months, Post-operative 9 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: No. In order to protect the privacy of patients, the original data of the study will not be disclosed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-adhesion barrier (Collarbarrier) in people with Thyroid Nodule and Thyroid Cancer, run by Inha University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Wook Yi, Professor (+82-32-890-3437, jinwook.yi@inha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voice Handicap Index - 30 (VHI-30) (time frame: Preoperative 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.