Effect of Polyglycolic Acid Mesh (Neoveil) in Thyroid Cancer Surgery

Study Overview
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Brief Summary
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This study is a randomized controlled study to investigate the effect of Polyglycolic Acid Mesh Sheet (NeoveilTM) on the thyroid cancer surgery.

Detailed Description
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Thyroid cancer is a most common solid organ cancer in South Korea, according to 2014 statistics from Korea Central Cancer Registry. The most important treatment of thyroid cancer is a surgery. Principle of thyroid cancer surgery is cancer-involved thyroid gland resection and central/lateral compartment of neck node dissection. Part of surgical complications associated with neck lymph node dissection are seroma and chyle leakage. Incidence of seroma and chyle leakage have been reported as 4-5% and 1-7% in previous studies. Currently, there's no effective agents to prevent these complications. Polyglycolic Acid Mesh Sheet (NeoveilTM) is a tissue strengthening repair agent which is prevent air or fluid leakage. It's effects were proven in various surgical field - prevent air leakage in lung surgery, reduce pancreatic fistula in pancreas surgery and so on. However, there's no result in thyroid cancer surgery. This study will investigate the usability of NeoveilTM in thyroid cancer surgery and have the effect of preventing seroma and chyle leakage.

Official Title
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Effect of Polyglycolic Acid Mesh (Neoveil) for Reducing Drain Amount and Chyle Leakage After Thyroid Cancer Surgery: A Prospective, Randomized Controlled Study

Conditions
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Thyroid Gland Carcinoma, Thyroid Cancer, Thoracic Duct Leak

Intervention / Treatment
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* Device: Neoveil (Polyglycolic Acid Mesh)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are between 20 and 70 years of age Patients who agreed to the study Patients undergoing thyroidectomy and cervical node dissection for thyroid cancer Patients without perithyroidal organ infiltration or distant metastasis Before the operation, bilateral vocal cord movement was normal Patients without significant abnormal findings in laboratory tests before surgery Exclusion Criteria: Patients judged to be inadequate by the person in charge of clinical trial Aspirin, anti-platelet medication within 7 days of admission Uncontrolled hypertension, diabetes, chronic renal failure, coagulation disorders Cardiovascular disease (angina, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack) Drug abuse and alcohol abuse History of esophagus and airway diseases Patients who participated in other clinical trials within 30 days Patients who had previous history of neck irradiation or neck surgery Patients with a history of allergy to drugs For women, pregnant and lactating patients

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Neoveil applied // Neoveil non-applied
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No use of Neoveil in the neck node dissection area | |
| Experimental: Neoveil<br>Use of Neoveil in the neck node dissection area | Device: Neoveil (Polyglycolic Acid Mesh)<br>* Apply the Neoveil (Polyglycolic Acid Mesh) in the neck node dissection area in thyroid cancer surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of triglyceride(TG) level in drained fluid | Triglyceride level in the drained fluid, check time 9:00AM, unit : mg/dL | Change from drain TG level from postoperative 1st day to postoperative 2nd day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drain amount | Drained fluid amount during 24 hours (Baseline 6:00 AM), unit : ml | Postoperative 1st and 2nd days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid cancer, Neoveil, seroma, chyle leakage