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临床试验/CTRI/2025/12/099464
CTRI/2025/12/099464尚未招募2/3 期

Intraoperative Nerve Monitoring (IONM) with Visual Identification versus Visual Identification Alone in Thyroid Surgery A Randomized Controlled Trial

Dr Tridib Kumar Amat1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年1月11日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1

研究概览

简要总结

This research is a prospective randomized controlled trial that evaluates two approaches to thyroid surgery: the use of intraoperative nerve monitoring (IONM) along with visual identification versus visual identification alone. The study aims primarily to determine whether incorporating IONM lowers the likelihood of recurrent laryngeal nerve (RLN) injury. It also assesses additional outcomes such as the duration required to locate the RLN, postoperative vocal cord function, total operative time, and the occurrence of postoperative complications.

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
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients aged more than 18 years undergoing thyroid surgery.
  • Patients with benign or malignant thyroid disease.
  • Patients who provide written informed consent.
  • Preoperative normal vocal cord function as assessed by indirect laryngoscopy.

排除标准

  • Previous thyroid or neck surgery (revision thyroidectomy).
  • Preoperative vocal cord palsy.
  • History of neck radiation.
  • Known allergy to anaesthetic agents used during nerve monitoring.
  • Severe comorbidities making general anaesthesia unsafe.

研究者

发起方
Dr Tridib Kumar Amat
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Tridib Kumar Amat

AIIMS ,Nagpur

研究点 (1)

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