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临床试验/NCT05421559
NCT05421559已完成不适用

Transection of Sternothyroid Muscle Increases the Rate of Exposure of the External Branch of the Superior Laryngeal Nerve During Thyroidectomy

Ahmed Aouf1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
122
试验地点
1
主要终点
rate of identification and exposure of the external laryngeal nerve during thyroidectomy

研究概览

简要总结

The sternothyroid (ST) muscle is closely adherent to the thyroid gland with oblique insertion into the thyroid cartilage. EBSLN passes through the sternothyroid laryngeal triangle with a parallel course deep to the ST muscle.

This study evaluates the transection of the sternothyroid muscle as a key step during thyroidectomy to increase the rate of exposure and visual identification of EBSLN compared to ST muscle retraction as a traditional technique.

详细描述

The study was conducted on patients eligible for total thyroidectomy, which meets the standard of the ATA Thyroid Guidelines. Preoperative biochemical thyroid function tests and neck ultrasound with FNAC of suspicious nodules confirmed the clinical diagnosis. Patients who had previously undergone neck surgery or irradiation or were preoperatively diagnosed with a vocal cord movement disorder, a vocal cord benign lesion, or speech disorders were excluded from the study. A random number was used to determine the patient group allocation.

Data about patients were gathered via history, examinations, and investigations. The patients were randomized (computer-generated) with the use of an opaque-sealed envelope into two groups; group A: conventional method of thyroidectomy with ST muscle retraction, group B: transection of ST muscle.

The study's primary endpoint was the identification rate of the EBSLN in both techniques. The secondary endpoints included: a comparison of operative time in both techniques as well as anatomical variability of the EBSLN according to Cernea classification, rate of injury of EBSLN, and changes in postoperative voice performance.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •eligible for total thyroidectomy
  • •no previous history of neck surgery or radiation
  • •no vocal cord pathology
  • •no voice disorders

排除标准

  • •not fit for surgery
  • •previous history of neck surgery or radiation
  • •vocal cord pathology
  • •vocal cord movement disorders

研究组 & 干预措施

conventional approach of thyroidectomy

Active Comparator

conventional method of thyroidectomy with ST muscle retraction

干预措施: thyroidectomy (Procedure)

transection approach of thyroidectomy

Active Comparator

method of thyroidectomy with ST muscle transection

干预措施: thyroidectomy (Procedure)

结局指标

主要结局

rate of identification and exposure of the external laryngeal nerve during thyroidectomy

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Ahmed Aouf
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ahmed Aouf

Dr, assistant lecturer of General Surgery

Kafrelsheikh University

研究点 (1)

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