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

Not Applicable

• Conditions: Thyroid Gland Carcinoma; Thyroid Cancer; Thoracic Duct Leak
• Interventions: Device: Neoveil (Polyglycolic Acid Mesh)

• Registration Number: NCT03510143
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2018-03-20
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-25
• Last Update Submitted: 2018-04-25
• Study First Posted: 2018-04-27
• Last Update Posted: 2018-04-27
• Study Start: 2018-05-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoveil	Neoveil (Polyglycolic Acid Mesh)	Use of Neoveil in the neck node dissection area

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Drain amount	Postoperative 1st and 2nd days	Drained fluid amount during 24 hours (Baseline 6:00 AM), unit : ml

Trial Locations

Locations (1)

Jin Wook Yi; 🇰🇷 Seoul, Korea, Republic of