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临床试验/NCT01163045
NCT01163045已完成2 期

Intraoperative Neuromonitoring and Neurostimulation of the Recurrent Laryngeal Nerve Versus Neurostimulation Alone in Thyroid Surgery: a Randomized Clinical Trial

University of Bologna2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2008年1月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
250
试验地点
2
主要终点
recurrent laryngeal nerve paralysis

研究概览

简要总结

The purpose of this study is to evaluate if intraoperative neuromonitoring associated to neurostimulation of recurrent laryngeal nerve reduce the rate of recurrent laryngeal palsy respect to neurostimulation alone.

详细描述

Anatomic and functional preservation of the recurrent laryngeal nerve is a key element of thyroid surgery. Surgical exposure and visual identification of the nerve during thyroid surgery has been shown to provide the best rates of normal postoperative vocal fold function. Nevertheless, identification of the nerve sometimes can be difficult in patients who are heavily scarred or who have undergone previous surgery. Moreover, an anatomical intact nerve does not always correlate with normal vocal fold function. So it is mandatory to identify the nerve and to establish its function. Two techniques are described to facilitate identification of the nerve and to test its function. One is the neurostimulation with laryngeal palpation which is an intermittent monitoring techniques that permits to evaluate the contraction of cricoarytenoid muscle (laryngeal twitch ) after stimulation of RLN or vagal nerve with an electric stimulator probe. More recently some authors have suggested a continuous intraoperative neuromonitoring which provide audio and visual feed back when the nerve is electrically or mechanically stimulated during thyroidectomy. However controversy remains as to whether intraoperative neuromonitoring confers any significant benefit in injury prevention of recurrent laryngeal nerve.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mono or bilateral thyroid surgery

排除标准

  • Previous thyroid and parathyroid surgery
  • Thyroidectomy with mono or bilateral neck dissection
  • Extended thyroidectomy for locally advanced thyroid carcinoma
  • Retrosternal goitre
  • Minimally invasive thyroid surgery
  • Preoperative palsy

结局指标

主要结局

recurrent laryngeal nerve paralysis

次要结局

未报告次要终点

研究者

发起方
University of Bologna
申办方类型
Other

研究点 (2)

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