Is Superior Laryngeal Nerve Really Safe During Thyroidectomy Using Ultrasonic Dissector.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Assessment of superior laryngeal nerve function
研究概览
简要总结
New devices and techniques are coming into use everyday. Ultrasonic dissectors (UDs) are such new devices which is a practical alternative to the usage of scalpel and sutures. UD's cause overheating of neighboring tissues in an area of 1 to 3 millimeters. Due to the generated heat UDs might cause nerve injury. The investigators would like to see if usage of UDs during thyroidectomy poses a risk for superior laryngeal nerve injury compared to conventional thyroidectomy.
详细描述
We see new advances in the practice of surgery nearly everyday. New techniques and devices became available and even newer ones are under developement. Ultrasonic Dissectors (UDs) which are primarily developed for laparoscopic surgery found widespread use in thyroid surgery. UDs while closing the nearby vessels cause overheating of neighboring tissues in a 1-3 mm. area. Due to the generated heat UDs might cause nerve injury. We would like to see if usage of UDs during thyroidectomy poses a risk for superior laryngeal nerve injury compared to conventional thyroidectomy where vessels are first sealed with sutures then cut. To this end patients in both conventional and ultrasonic dissector thyroidectomy arms will be checked for superior laryngeal nerve function the day following operation and six months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having thyroidectomy
排除标准
- •Previous neck surgery
- •Thyroid cancers
- •History of superior or inferior laryngeal nerve paralysis
- •History of neck irradiation
- •Pregnant or lactating women
研究组 & 干预措施
Ultrasonic Dissector Thyroidectomy
Thyroidectomy using harmonic focus (r) device
干预措施: Thyroidectomy using harmonic focus (r) (Device)
Classic thyroidectomy
Patients having conventional thyroidectomy
干预措施: Conventional thyroidectomy (Procedure)
结局指标
主要结局
Assessment of superior laryngeal nerve function
时间窗: 6 months
Patients will be checked for superior laryngeal nerve function by laryngostroboscopy one day after thyroidectomy and 6 months after thyroidectomy.
次要结局
- Assessment of inferior laryngeal nerve function(6 months)
- Assessment of other complications(1 week)
