跳至主要内容
临床试验/CTRI/2023/11/059854
CTRI/2023/11/059854尚未招募4 期

Role of intraoperative neuromonitoring in identification of external branch of superior laryngeal nerve during thyroidectomy operation

Dr Sanjib Barman1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月23日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To evaluate the efficacy of intraoperative neuromonitoring in identification of external branch of superior laryngeal nerve during thyroidectomy operation in comparison to the standard visual identification

研究概览

简要总结

Thyroidectomy is a common operation performed in otorhinolaryngology. The presence of nodules or tumours on the thyroid gland is the most common reason for thyroid surgery. Nodules can either be benign or malignant. The recurrent laryngeal nerve (RLN) and external branch of superior laryngeal nerve (EBSLN) are the main structures that must be preserved in thyroid surgery to prevent postoperative voice deterioration. One of the most difficult aspects of thyroid surgery is preventing Injury to the external branch of superior laryngeal nerve. EBSLN damage rates have been reported to range from 0 to 58%, depending on different postoperative assessment methods. The EBSLN innervates the cricothyroid muscle (CTM), whose primary function is to raise the tension of the adducted ipsilateral vocal folds during elevation of pitch. Clinical symptoms primarily include: vocal fatigue, reduced vocal frequency range, particularly with regard to raising pitch which may lead to decreased quality of life, especially for those voice professionals. Even in those who are not singers, the injury could result in objective voice quality changes. However EBSLN has received minimal attention, for which Delbridge declared it as the "Neglected nerve in thyroid surgery". Careful anatomic identification during dissection can help prevent injury to the EBSLN during thyroid surgery. Intraoperative neuromonitoring (IONM) has been suggested as an addition to the standard visual identification of both the recurrent laryngeal nerve (RLN) and EBSLN during thyroid surgery, in an effort to aid in the visualisation of and hence reduce the incidence of EBSLN injury during thyroidectomy operation. This study is the first study from our institute whereby we will evaluate the contribution of intraoperative neuromonitoring in identification and preservation of external branch of superior laryngeal nerve during thyroidectomy operation and assess any difficulties and pitfalls during the use of the nerve monitor in such cases.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • All patients within the age group between 20 and 50 years with thyroid swellings, nodular or cystic, benign or malignant, subjected to thyroidectomy will be included in the study.

排除标准

  • 1.Previous thyroid surgery or other surgery involving neck 2.Previous history of radiation to neck 3.Anaplastic carcinoma of thyroid 4.Patients with any preoperative vocal cord mobility disorder 5.Pregnancy and lactation 6.Bleeding diathesis, anemia, poor anesthetic risk or uncontrolled medical illness.

结局指标

主要结局

To evaluate the efficacy of intraoperative neuromonitoring in identification of external branch of superior laryngeal nerve during thyroidectomy operation in comparison to the standard visual identification

时间窗: During operation, post operative day 1,5 and 15

次要结局

  • To assess pitfalls in the use of nerve monitor during external branch of superior laryngeal nerve identification in thyroidectomy operation.(During operation)

研究者

发起方
Dr Sanjib Barman
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sanjib Barman

Silchar Medical College and Hospital

研究点 (1)

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