Effect of Intraoperative Nerve Monitoring on Voice Quality During Thyroid Surgery
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
- Voice analysis
研究概览
简要总结
"Effect of intraoperative nerve monitoring on voice quality during thyroid surgery"
Thyroidectomy is a quite often surgical procedure applied by both head and neck surgeons and endocrine surgeons.Recent advances in surgical and technological area achieve a remarkable decrease in the complication rates. In case of these advances, patients still have fear related with their voice. In this study, investigators aimed to investigate voice changes during thyroid surgery and effect of intraoperative nerve monitoring to the voice quality.
详细描述
In order to minimize the complication rates and voice disturbances during thyroidectomy, intraoperative nerve monitoring(IONM) is a widely used intervention. In this study investigators will compare conventional surgery with IONM used surgery. Randomly chosen half of the patients will be operated with IONM. Vagus, recurrent and superior laryngeal nerves will be monitored during surgery and measured for nerve integrity . Rest of the patients will be operated with standard conventional method. All participants will be analyzed with a computer program for their voice quality preoperatively and postoperatively at 14th day of surgery.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological diagnosis of nodular or multinodular goiter
- •Clinical, radiological and pathologically diagnosed thyroid cancer
- •Must be able to speak (for voice recording)
排除标准
- •Pregnancy
- •Previous thyroid surgery
- •Previous laryngeal operations
- •Professional voice users (e.g. singers)
结局指标
主要结局
Voice analysis
时间窗: up to 2nd week voice recording
Comparison of Jitter(microseconds) and Shimmer(dB) values of recorded voices
次要结局
- Operation time(duration of surgery, up to 3 hours)
研究者
TURGUT DONMEZ
General Surgeon, MD
Lütfiye Nuri Burat Government Hospital