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

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Brief Title

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

Official Title

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

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 Type

Interventional


Primary Outcome

Change of triglyceride(TG) level in drained fluid

Secondary Outcome

 Drain amount

Condition

Thyroid Gland Carcinoma

Intervention

Neoveil (Polyglycolic Acid Mesh)

Study Arms / Comparison Groups

 Control
Description:  No use of Neoveil in the neck node dissection area

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

330

Start Date

May 1, 2018

Completion Date

December 31, 2020

Primary Completion Date

May 1, 2020

Eligibility Criteria

        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
      

Gender

All

Ages

20 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, +82-2-2072-3243, [email protected]

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT03510143

Organization ID

1802-087-923


Responsible Party

Principal Investigator

Study Sponsor

Seoul National University Hospital

Collaborators

 Green Cross Corporation

Study Sponsor

, , 


Verification Date

April 2018