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

April 25, 2018 updated by: Jin Wook Yi, Seoul National University Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of triglyceride(TG) level in drained fluid
Time Frame: 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
Change from drain TG level from postoperative 1st day to postoperative 2nd day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Green Cross Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2018

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

March 20, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (Actual)

April 27, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1802-087-923

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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