NCT04320901Unknown不适用
Comparative Analysis Between Harmonic Versus LigaSure in Transoral Endoscopic Thyroidectomy: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Blood loss
研究概览
简要总结
Open label randomized controlled study, for Harmonic versus Ligasure in transoral endoscopic thyroid surgery.
详细描述
- This is a prospective randomized controlled study. The principal investigator or another clinical investigator in charge will individually inform the patients about the study, on the day before surgery.
- When informed consent is obtained, an investigator in charge of randomization only, will randomize the patients.
- According to randomization, the experimental group will Ligasure and the control group will use Harmonic ACE 7+. Other than the randomized use of energy devices, the protocol for TOETVA is performed as usual.
- Operation time (from insertion of the laparoscopic camera to removal of the camera), number of times the camera was cleaned, intraoperative blood loss will recorded.
- Postoperative hospital stay, visual analog pain scale, blood cell count and inflammatory parameters, postoperative drain amount will recorded.
- Complications of thyroid surgery (vocal cord dysfunction, hypoparathyroidism) are compared for safety assessment.
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
- None
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 planned to transoral endoscopic thyroidectomy
- •Age between 20 to 70
- •Voluntarily consenting to the study and study agreement
- •No local invasion or distant metastasis
- •Normal vocal cord function in laryngoscopic exam
- •No significant abnormalities in preoperative laboratory tests
排除标准
- •Take aspirin or antiplatelet drugs within 7 days before admission
- •Uncontrolled hypertension, diabetes, chronic renal failure, or coagulation disease
- •History of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)
- •Substance abuse and alcohol abuse
- •History of esophageal and airway diseases
- •Patient was participated in other clinical trials within 30 days
- •History of neck irradiation or surgery
- •History of severe drug allergies
- •Pregnant or lactating women
结局指标
主要结局
Blood loss
时间窗: During the procedure
Estimated blood loss during the lobectomy
Camera cleaning frequency
时间窗: During the procedure
Numbers of camera cleaning during the lobectomy
Operation time
时间窗: During the procedure
Surgery time during the thyroid lobectomy
次要结局
- Drain amount(Postoperative 1st and 2nd days)
- Pain score(Postoperative 1st and 2nd days)
研究者
Jin Wook Yi
Assistant Professor
Inha University Hospital
研究点 (2)
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