NCT03553342Unknown3 期
Efficacy of Oral Corticosteroid Therapy in Recurrent Paralyzes After Thyroidectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Evaluate the efficacy of oral corticosteroid in remobilization of vocal cords at seven days for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy
研究概览
简要总结
Thyroidectomy is a common surgical procedure in France. Recurrent paralysis is one of the main complications. Oral corticosteroid therapy are frequently used at a dosage of 1mg/kg for seven days, in case of recurrent paralysis to obtain remobilization as early as possible.
The main objective is to evaluate the efficacy of oral corticosteroid therapy in remobilization of vocal cords at seven days in patients with unilateral recurrent paralysis after 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
- Double (Participant, Investigator)
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 simple total thyroidectomy or lobo-isthmectomy
- •Patients over eighteen years old
- •Free subject, whitout tutorship or curatorship or subordination
- •Informed consent and signed by the patient after clear and fair information about the study.
排除标准
- •Patients operated on a total thyroidectomy with médiastino-recurrent dissection for cancer etiology
- •Patients with preoperative recurrent paralysis
- •Patients with hypersensitivity to prednisolone or any of the excipients.
- •Patients with contraindication to use Solupred
- •Patients with anti-inflammatory of acetylsalicylic acid
- •Patient with evolving virosis (hepatitis, herpes, chicken pox, zoster)
研究组 & 干预措施
Corticoids
Experimental
干预措施: Corticoids (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Evaluate the efficacy of oral corticosteroid in remobilization of vocal cords at seven days for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy
时间窗: Seven days
evaluated by naso fibroscope inspection
次要结局
未报告次要终点
研究者
研究点 (1)
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