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临床试验/NCT06161467
NCT06161467尚未招募不适用

Transcutaneous Laryngeal Ultrasoungraphy (TLUS) as an Alternative to Direct Flexible Laryngoscopy (DFL) in Assessment of Vocal Cords Appearance in Patients Underwent Thyroid Surgery

Assiut University0 个研究点目标入组 46 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
46
主要终点
Vocal cords movement

研究概览

简要总结

To evaluate the diagnostic value of ultrasound in the assessment of the vocal cords compared with direct flexible laryngoscopy

详细描述

Thyroid and parathyroid surgery are the most common procedures in endocrine surgery worldwide. They are mainly associated with two major complications: recurrent laryngeal nerve (RLN) palsy and hypoparathyroidism, The preservation of recurrent laryngeal nerve (RLN) is an essential part of thyroid surgery {1}. The various methods to test the normal functionality of vocal cords (VCs) include direct visualisation under the fiber bronchoscope, indirect laryngoscopy, laryngeal muscles electromyography, computed tomography (CT), and magnetic resonance imaging (MRI). We aimed to assess the usefulness of ultrasound (USG) in the examination of VC morphology and movement.

Recurrent laryngeal nerve injury ranges from 1.4 to 5.1% following surgery involving the thyroid gland.

Otolaryngology and Head and Neck Surgery suggested that all patients undergoing thyroid and parathyroid procedures should undergo routinely preoperative and postoperative DFL [6].

Laryngoscopy is considered the golden standard to evaluate vocal fold mobility preoperatively. As it can demonstrate a paralysis of the recurrent laryngeal nerve,. Yet it is not common practice for many endocrine surgery teams because it is time consuming, imposes extra costs, and is in general, an unpleasant experience for some patients.{2} head and neck ultrasonography is a cost effective imaging tool that is currently used as an extension of patient physical examination. That is based on its safety (non invasive and non ionizing radiation dependent), repeatability, availability and good patient compliance (pain less and require no sedation). {3} recently portable ultrasound devices became widely available with dramatic improvement of the imaging quality rendering to increased diagnostic accuracy. Availability, usability and mobility of the devices encourage bedside examination which is essential in non mobile patient and ICU patient [4] .

However, the experience is limited and the reliability of the TLUS in thyroid and parathyroid surgery is still being debated

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients scheduled for thyroid surgery
  • Patients underwent thyroid surgery

排除标准

  • Patients with vocal cord paralysis because of any cause other than thyroid surgery complications

结局指标

主要结局

Vocal cords movement

时间窗: Two years

Assessment of vocal cords movement by Transcutaneous laryngeal ultrasoungraphy (TLUS) as an alternative to direct flexible laryngoscopy (DFL)

Vocal cords appearance

时间窗: Two years

Assessment of vocal cords appearance by Transcutaneous laryngeal ultrasoungraphy (TLUS) as an alternative to direct flexible laryngoscopy (DFL)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Walaa Mohamed Ali sayd

Principal Investigator

Assiut University

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