Effect of Polyglycolic Acid Mesh (Neoveil) in Thyroid Cancer Surgery
NCT ID: NCT03510143
Last Updated: 2018-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
330 participants
INTERVENTIONAL
2018-05-01
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control
No use of Neoveil in the neck node dissection area
No interventions assigned to this group
Neoveil
Use of Neoveil in the neck node dissection area
Neoveil (Polyglycolic Acid Mesh)
Apply the Neoveil (Polyglycolic Acid Mesh) in the neck node dissection area in thyroid cancer surgery.
Interventions
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Neoveil (Polyglycolic Acid Mesh)
Apply the Neoveil (Polyglycolic Acid Mesh) in the neck node dissection area in thyroid cancer surgery.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
70 Years
ALL
No
Sponsors
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Green Cross Corporation
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Jin Wook Yi
Clinical Assistant Professor
Locations
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Jin Wook Yi
Seoul, , South Korea
Countries
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Central Contacts
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References
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Jang JY, Shin YC, Han Y, Park JS, Han HS, Hwang HK, Yoon DS, Kim JK, Yoon YS, Hwang DW, Kang CM, Lee WJ, Heo JS, Kang MJ, Chang YR, Chang J, Jung W, Kim SW. Effect of Polyglycolic Acid Mesh for Prevention of Pancreatic Fistula Following Distal Pancreatectomy: A Randomized Clinical Trial. JAMA Surg. 2017 Feb 1;152(2):150-155. doi: 10.1001/jamasurg.2016.3644.
Kuwata T, Shinohara S, Takenaka M, Oka S, Chikaishi Y, Hirai A, Kuroda K, So T, Tanaka F. The impact of covering the bulla with an absorbable polyglycolic acid (PGA) sheet during pneumothorax surgery. Gen Thorac Cardiovasc Surg. 2016 Sep;64(9):558-60. doi: 10.1007/s11748-015-0545-8. Epub 2015 Apr 10.
Kobayashi S, Takeda Y, Nakahira S, Tsujie M, Shimizu J, Miyamoto A, Eguchi H, Nagano H, Doki Y, Mori M. Fibrin Sealant with Polyglycolic Acid Felt vs Fibrinogen-Based Collagen Fleece at the Liver Cut Surface for Prevention of Postoperative Bile Leakage and Hemorrhage: A Prospective, Randomized, Controlled Study. J Am Coll Surg. 2016 Jan;222(1):59-64. doi: 10.1016/j.jamcollsurg.2015.10.006. Epub 2015 Oct 23.
Other Identifiers
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1802-087-923
Identifier Type: -
Identifier Source: org_study_id
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