Clinical Utility of Low-Current Stimulation for Recurrent Laryngeal Nerve Protection During Thyroid Surgery: A Single-Center Prospective Randomized Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of Participants With Permanent Recurrent Laryngeal Nerve Injury Confirmed by Electronic Laryngoscopy
研究概览
简要总结
This single-center prospective randomized interventional study evaluated whether intraoperative low-current stimulation could assist recurrent laryngeal nerve localization and reduce temporary recurrent laryngeal nerve injury during thyroid surgery.
详细描述
A total of 150 patients undergoing thyroid surgery at the Second Affiliated Hospital of Kunming Medical University were randomly allocated in a 1:1:1 ratio to conventional anatomical identification, 3 mA low-current stimulation, or 5 mA low-current stimulation. All participants underwent preoperative and postoperative electronic laryngoscopy. The primary outcome was temporary recurrent laryngeal nerve injury. Secondary outcomes included permanent recurrent laryngeal nerve injury, operative duration, intraoperative blood loss, postoperative hospital stay, and stimulation-related adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for thyroid surgery.
- •No history of prior thyroid or neck surgery.
- •Normal bilateral vocal cord mobility on preoperative electronic laryngoscopy.
- •Written informed consent provided before enrollment.
排除标准
- •Preoperative recurrent laryngeal nerve dysfunction.
- •Previous neck surgery.
- •Incomplete clinical data.
- •Severe comorbidities precluding standardized perioperative assessment.
结局指标
主要结局
Number of Participants With Permanent Recurrent Laryngeal Nerve Injury Confirmed by Electronic Laryngoscopy
时间窗: 6 months after surgery
Permanent recurrent laryngeal nerve injury is defined as unilateral or bilateral vocal cord paresis or paralysis detected after surgery and still present at the 6-month postoperative assessment, as confirmed by electronic laryngoscopy. The number of participants meeting this definition will be reported.
次要结局
- Number of Participants With Vocal Cord Paresis or Paralysis Persisting at 6 Months, as Assessed by Electronic Laryngoscopy(6 months after surgery)
- Total Operative Duration in Minutes(Intraoperative period)
- Intraoperative blood loss(Intraoperative period)
- Duration of Postoperative Hospital Stay in Days(From the date of surgery until hospital discharge, assessed up to 30 days after surgery)
- Number of Participants With Stimulation-Related Adverse Events(From initiation of intraoperative nerve stimulation through 30 days after surgery)
研究者
Siqi Li
Principal Investigator
The Second Affiliated Hospital of Kunming Medical University