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

Seoul National University

Status

Unknown

Conditions

Thyroid Gland Carcinoma

Thoracic Duct Leak

Thyroid Cancer

Treatments

Device: Neoveil (Polyglycolic Acid Mesh)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03510143

1802-087-923

Details and patient eligibility

About

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

Full 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.

Enrollment

330 estimated patients

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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