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

Seoul National University Hospital330 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

330

Conditions

Thyroid Gland Carcinoma Thyroid Cancer Thoracic Duct Leak

Interventions

Neoveil (Polyglycolic Acid Mesh)DEVICE

Apply the Neoveil (Polyglycolic Acid Mesh) in the neck node dissection area in thyroid cancer surgery.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Jin Wook Yi

Seoul, South Korea

Outcomes

Primary Outcomes

Change of triglyceride(TG) level in drained fluid

Triglyceride level in the drained fluid, check time 9:00AM, unit : mg/dL

Time frame: Change from drain TG level from postoperative 1st day to postoperative 2nd day

Secondary Outcomes

Drain amount

Drained fluid amount during 24 hours (Baseline 6:00 AM), unit : ml

Time frame: Postoperative 1st and 2nd days

Central Contacts

Jin Wook Yi, MD, MS

CONTACT

+82-2-2072-3243 gnsljw@gmail.com

Data from ClinicalTrials.gov

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