Methylene Blue Spray for Identification of Recurrent Laryngeal Nerve and Parathyroid Glands During Thyroidectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- detection of the recurrent larngeal nerve unstained
研究概览
简要总结
Thyroidectomy is the procedure by which surgeons treat various thyroid diseases and is considered the commonest endocrinal surgery. Yet, it carries a risk for intraoperative complications. The most distressing complications are recurrent laryngeal nerve and parathyroid injuries. Methylene blue spray is a technique than can be used for easy identification of both recurrent laryngeal nerve and parathyroid glands so we can avoid their injuries.
详细描述
Thyroid disorders constitute the second most common endocrine disease following diabetes mellitus. Thyroid surgery is one of the most frequently operated Head and Neck surgeries. Post-thyroidectomy complications are not uncommon. Parathyroids and Recurrent Laryngeal Nerve (RLN) are two of the complications of thyroidectomy that cause significant postoperative morbidity Due to the advances in thyroids surgeries, the occurrence of postoperative complications has been decreased, but when occurred, they cause lifelong handicap. The most important complications encountered are injury to the RLN and parathyroids. Meticulous dissection is a key factor in minimizing the occurrence of complications During thyroidectomy, careful dissection can protect the parathyroid glands and RLN. Various methods were used including capsular dissection, attention to protection of the arterial supply to parathyroids, avoiding unnecessary manipulation in the area of RLN Methylene blue spraying is a new technique that allows identification of both parathyroid glands and recurrent laryngeal nerves
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 16 years and older.
- •Both sexes.
- •Patients who are candidate for thyroid surgery and euthyroid.
排除标准
- •- Patients with hyper- or hypo-thyroid status.
- •Patients who were unfit for surgery.
- •Patients with unilateral or bilateral vocal cord palsy on preoperative indirect laryngoscopy
- •Patients with thyroid malignancy by preoperative FNAC.
- •Patients with hypersensitivity to methylene blue were excluded.
结局指标
主要结局
detection of the recurrent larngeal nerve unstained
时间窗: one minute after dye application
the methylene blue dye stain the background and the RLN appears unstained
detection of the parathyroig glands
时间窗: 3 minutes after dye application
the methylene blue dye stain washed out and the parathyroid gland remained stained after 3 minutes
次要结局
未报告次要终点
研究者
Yasser Ali Orban
Dr
Zagazig University