Comparison of Different Types of Electrostimulation Probes for Intraoperative Nerve Monitoring During Thyroidectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Comparison of amplitude values of bipolar vs. monopolar stimulation
研究概览
简要总结
Intraoperative nerve monitoring is often used in many centers during thyroidectomy. According to the investigators' knowledge, there's no study showing superiority between bipolar and monopolar stimulation probes used for nerve monitoring during thyroid surgery. In this study, the investigators aimed to compare two different types of probes and find out superiorities.Twenty-one patients who underwent primary total thyroidectomy or hemithyroidectomy were included in the study. During surgery, amplitude and latency values obtained in the same patient with both bipolar and monopolar stimulation probes from 10 different anatomical spots [vagal nerve, recurrent laryngeal nerve inferior portion, recurrent laryngeal nerve superior portion, external branch of superior laryngeal nerve (EBSLN)] were recorded prospectively, both when sheath was intact and after being dissected.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •who underwent thyroid surgery
排除标准
- •Perioperative loss of electromyographic(EMG) signal (LOS) during intraoperative nerve monitorization
- •patients with additional pathology that may affect vocal cord function,
- •abnormal preoperative laryngeal examination
- •history of thyroid, vocal cord or other neck surgery
- •advanced cancer, RLN, esophageal or trachea invasion
结局指标
主要结局
Comparison of amplitude values of bipolar vs. monopolar stimulation
时间窗: One week
Bipolar and monopolar probes were compared regarding amplitudes(mA), at each spot and on both sides (right \& left) via Wilcoxon Signed Rank Test.
Comparison of Latency values of bipolar vs. monopolar stimulation
时间窗: One week
Bipolar and monopolar probes were compared regarding latencies(ms) , at each spot and on both sides (right \& left) via Wilcoxon Signed Rank Test.
次要结局
- Comparison of stimulation with vs. without overlying fascia on nerve(One week)
- Comparison of stimulation pre- vs. post-resection without overlying fascia on nerve(One week)
- Comparison of stimulation of inferior vs. superior parts of recurrent nerve.(One week)
研究者
Ozer Makay
Associate Professor Ozer Makay
Ege University