Randomized Controlled Trial of Preoperative Corticosteroids in Autoimmune ThyroidDisease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 6
- 主要终点
- Thyroid difficulty Scale score
研究概览
简要总结
This study proposes to randomize patients about to undergo surgery for their autoimmune, inflammatory thyroid disease, and determine if a short course of corticosteroids decreases the inflammation of the gland and makes surgery less difficult.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Inclusion Criteria:
- •■ Graves' disease or Hashimoto's disease with positive thyroid autoantibodies (TgAb, TPO, TSI, and/or TRAb) undergoing total thyroidectomy for their disease.
排除标准
- •Pediatric patients < 18
- •Prior treatment with RAI
- •Prior neck surgeries
- •Known diagnosis of thyroid cancer
- •Diabetic patients on medications
- •A history of adverse reactions to corticosteroids.
- •Patients on any immunosuppressive regimen (such as organ transplant patients or patients treated for other autoimmune conditions). This includes patients with recent history of steroid therapy, or a history of adverse reactions to corticosteroids.
研究组 & 干预措施
placebo
Will be given Placebo
干预措施: Placebo (Drug)
Steroids
Will be given pre-operative corticosteroid regimen
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Thyroid difficulty Scale score
时间窗: Day of Surgery
This scale is completed by the surgeon to assess the difficulty of a thyroid operation, and includes 4 parameters (vascularity, friability, mobility/fibrosis, and gland size). The scale ranges from 4 points (best outcome) - 20 points (worst outcome). Higher scores indicate a more difficult operation.
次要结局
- Surgical complication of transient hypoparathyroidism(Two weeks post-operative and six weeks post-operative)
- Surgical complication of permanent hypoparathyroidism(through study completion, or 6 months)
- Change in SF-20 at 6 months(through study completion, an average of 6 months)
- Tg(through study completion, an average of 6 months)
- TgAB(through study completion, an average of 6 months)
- TPO(through study completion, an average of 6 months)
- TSI(through study completion, an average of 6 months)
- TRAb(through study completion, an average of 6 months)
- ThyPRO(through study completion, an average of 6 months)
- Change in blood flow / vascularity(Pre-operative visit and Day of Surgery)
- Surgical complication of transient hypocalcemia(Two weeks post-operative and six weeks post-operative)
- Surgical complication of permanent hypocalcemia(through study completion, or 6 months)
- Surgical complication of recurrent laryngeal nerve palsy(Two weeks post-operative and six-weeks post-operative, if clinically indicated)
- Change in SF-20 at 6 weeks(Six weeks post-operative)
研究者
Alexandria D. McDow
Assistant Professor of Surgery
Indiana University