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| Name | Class |
|---|---|
| Green Cross Corporation | INDUSTRY |
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This study is a randomized controlled study to investigate the effect of "Polyglycolic Acid Mesh Sheet (NeoveilTM)" on the thyroid cancer surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No use of Neoveil in the neck node dissection area | |
| Neoveil | Experimental | Use of Neoveil in the neck node dissection area |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoveil (Polyglycolic Acid Mesh) | Device | Apply the Neoveil (Polyglycolic Acid Mesh) in the neck node dissection area in thyroid cancer surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of triglyceride(TG) level in drained fluid | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Drain amount | Drained fluid amount during 24 hours (Baseline 6:00 AM), unit : ml | Postoperative 1st and 2nd days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Wook Yi, MD, MS | Contact | +82-2-2072-3243 | gnsljw@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jin Wook Yi | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27784046 | Result | 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. | |
| 25860987 |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D049291 | Seroma |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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Neoveil applied // Neoveil non-applied
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Participants cannot know the Neoveil apply in their surgery
| 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. |
| 26597705 | Result | 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. |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |