Thoracic Duct Leak, Thyroid Cancer, Thyroid Gland Carcinoma
Conditions
Keywords
thyroid cancer, Neoveil, seroma, chyle leakage
Brief summary
This study is a randomized controlled study to investigate the effect of Polyglycolic Acid Mesh Sheet (NeoveilTM) on the thyroid cancer surgery.
Detailed description
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.
Interventions
DEVICENeoveil (Polyglycolic Acid Mesh)
Apply the Neoveil (Polyglycolic Acid Mesh) in the neck node dissection area in thyroid cancer surgery.
Sponsors
Green Cross Corporation
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants cannot know the Neoveil apply in their surgery
Intervention model description
Neoveil applied // Neoveil non-applied
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of triglyceride(TG) level in drained fluid | Change from drain TG level from postoperative 1st day to postoperative 2nd day | Triglyceride level in the drained fluid, check time 9:00AM, unit : mg/dL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drain amount | Postoperative 1st and 2nd days | Drained fluid amount during 24 hours (Baseline 6:00 AM), unit : ml |
Countries
South Korea
Contacts
Primary ContactJin Wook Yi, MD, MS
Outcome results
None listed