The Identification of Recurrent Laryngeal Nerve by Injection of Methylene Blue Dye Into the Inferior Thyroid Artery in Comparison to The Conventional Technique During Thyroidectomy, Comparative Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Easy and fast identification of recurrent laryngeal nerve
研究概览
简要总结
The aim of the study is to evaluate the value of injection of methylene blue dye into the inferior thyroid artery for the help of the identification and dissection of recurrent laryngeal nerve, so thyroidectomy could be done with fewer complications in comparison to conventional technique
详细描述
The aim of the study is to evaluate the effectiveness of methylene blue dye injection into the inferior thyroid artery for enhancing the intraoperative visualization of the RLN during thyroidectomy. Also, this method was compared to conventional RLN identification techniques in terms of nerve identification time, blood loss, complication rates, and postoperative outcomes, while assessing the safety and feasibility of using methylene blue in thyroid surgery.
The study included 40 patients with indications for thyroidectomy due to benign thyroid conditions. Patients were randomly assigned into two equal groups:
- Group A: 20 patients underwent injection of methylene blue dye into the inferior thyroid artery to aid in identifying the recurrent laryngeal nerve (RLN).
- Group B: 20 patients underwent conventional RLN identification during thyroidectomy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients who present with simple nodular goiter, solitary thyroid nodule, controlled toxic goiter and failed medical treatment with indication for thyroidectomy.
- •Patents undergoing primary surgery (not recurrent).
- •Patients who are willing to undergo surgery under general anesthesia without any preoperative complications or major diseases.
- •Either gender in the age group of 18-60 years
排除标准
- •Previous thyroid surgery.
- •Malignant goiter.
- •Major cardiac diseases, renal diseases or patients who are unfit for surgery.
- •Methylene blue allergies.
- •Pregnancy.
- •Patients who refuse to participate in the study.
- •Presence of any preoperative cord pathology or patients with dysphonia.
研究组 & 干预措施
Methylene blue group
After ligation of the superior pole, 0.5-1 ml of sterile methylene blue dye was injected into the inferior thyroid artery. The thyroid tissue absorbed the dye, while the RLN remained unstained, appearing as a white structure in the tracheoesophageal groove. This aided in its early and safe identification, reducing the risk of injury during dissection.
干预措施: Methylene blue group (Procedure)
结局指标
主要结局
Easy and fast identification of recurrent laryngeal nerve
时间窗: Procedure (Time taken for identification of the recurrent laryngeal nerve after delivery of thyroid lobe (in minutes))
Thyroid gland absorbed the dye and got stained blue while the RLN didn't take the dye and appeared as a white structure in the tracheoesophageal groove
次要结局
- Lower intra-operative blood loss(The duration of the procedure ranging from one to two hours)