跳至主要内容
临床试验/NCT01812395
NCT01812395Unknown不适用

Is Superior Laryngeal Nerve Really Safe During Thyroidectomy Using Ultrasonic Dissector.

S.B. Konya Education and Research Hospital2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

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

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

Active Comparator

Thyroidectomy using harmonic focus (r) device

干预措施: Thyroidectomy using harmonic focus (r) (Device)

Classic thyroidectomy

Active Comparator

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)

研究者

发起方
S.B. Konya Education and Research Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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