A Prospective Randomized Study of LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Opreation Duration
研究概览
简要总结
The aim of this prospective randomized study was to investigate if the LigaSure vessel sealing system can reduce the operation duration and the postoperative drainage amount in patients undergoing neck dissection.
详细描述
We compared the differences in perioperative and postoperative variables between LigaSure Small Jaw®-assisted and conventional neck dissection in head and neck cancer patients.
Patients who were scheduled to undergo neck dissection due to head and neck cancer were eligible for this study. After receiving a detailed explanation, all patients signed an informed consent form before randomization. The study group were treated using the LigaSure vessel sealing system (Small Jaw®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection. Relevant data included tumor-related variables, perioperative parameters, postoperative drainage status, postoperative subjective pain, and analgesic consumption amount were recorded and analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 20 to 80 years scheduled to receive neck dissection due to head and neck cancer
排除标准
- •history of coagulation disorders
- •prior radiation to the neck
- •prior neck dissection
- •declined to participate
结局指标
主要结局
Opreation Duration
时间窗: 1 day
The duration from incision of cervial skin till the completion of lymph node dissection
次要结局
- Postoperative Oral Analgesic Consumption(2 weeks)
- Intraoperative Blood Loss(1 day)
- Postoperative Subjective Pain Status(2 weeks)
- Postoperative Injected Analgesic Amount(2 weeks)
- Postoperative Drainage Amount(2 weeks)
研究者
Shih-An Liu
Attending physician
Taichung Veterans General Hospital