The Safety and Efficacy of the Harmonic Scalpel in Neck Dissection : A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- number of harvested lymph nodes
研究概览
简要总结
Recently, the HS has been used in head and neck surgery as an alternative to conventional hand-tied ligation for hemostasis, which is a time-consuming procedure. Limited data have been published on the evidence of its safety in ND, especially in radical ND. Researchers investigated the safety and efficacy of the Harmonic scalpel (HS) in neck dissection (ND), while using conventional hand-tied ligation to a minimum, in terms of operating time, blood loss, drainage and complications.
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)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preoperative diagnosis of head and neck squamous cell carcinoma
- •surgery as initial treatment
排除标准
- •cases in which the ND specimen could not be separated from the primary tumor
- •past history of neck surgery
结局指标
主要结局
number of harvested lymph nodes
时间窗: when the pathologist examine the specimen which is within 1 week after operation
number of harvested lymph nodes counted from the lymphfatty tissue after neck dissection
intra-operative surgery-related complications
时间窗: complicated events will be monitored during the operation which takes 60 min to 160 min according to the extent of surgery
major vessel laceration, major nerve injury, and penetration into adjacent vital structures such as trachea or esophagus
post-operative complications
时间窗: participants will be followed for 1 month after the surgery
hemorrhage, hematoma, seroma, chylous leakage, and neurologic complications
次要结局
- operating time(when the neck dissection specimen is removed from the patient at an average time of 60 min to 160 min according to the extent of surgery)
- intraoperative bleeding(The amount will be estimated at the end of the surgery at an average time of 60 min to 160 min according to the extent of surgery)
- total amount of drainage(estimated until the drain tube is removed at the average of 4 to 7 days according to the extent of surgery)
- duration of drain placement(estimated at 6AM daily, until the drain is removed at an average of 4 to 7 days according to the extent of surgery)
- days of hospital stay(documented when the patient leaves the hospital at an average time of 10 to 28 days according to the extent of surgery)