Effect of Anti-adhesion Barrier on the Voice Quality After Thyroidectomy.
NCT ID: NCT04853680
Last Updated: 2021-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2021-07-01
2023-07-30
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Anti-adhesion barrier (Collarbarrier)
Collagen derived anti-adhesion barrier
Control
No use of anti-adhesion barrier. After the thyroidectomy, don't use the anti-adhesion barrier before the wound closure.
No interventions assigned to this group
Interventions
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Anti-adhesion barrier (Collarbarrier)
Collagen derived anti-adhesion barrier
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
70 Years
ALL
No
Sponsors
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Inha University Hospital
OTHER
Responsible Party
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Jin Wook Yi
Assistant Professor
Locations
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Inha University Hospital
Incheon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-12-023-001
Identifier Type: -
Identifier Source: org_study_id
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