Effect of Polyglycolic Acid Mesh (Neoveil) for Reducing Drain Amount and Chyle Leakage After Thyroid Cancer Surgery: A Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Change of triglyceride(TG) level in drained fluid
研究概览
简要总结
This study is a randomized controlled study to investigate the effect of "Polyglycolic Acid Mesh Sheet (NeoveilTM)" on the thyroid cancer surgery.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants cannot know the Neoveil apply in their surgery
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control
No use of Neoveil in the neck node dissection area
Neoveil
Use of Neoveil in the neck node dissection area
干预措施: Neoveil (Polyglycolic Acid Mesh) (Device)
结局指标
主要结局
Change of triglyceride(TG) level in drained fluid
时间窗: 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
次要结局
- Drain amount(Postoperative 1st and 2nd days)
研究者
Jin Wook Yi
Clinical Assistant Professor
Seoul National University Hospital