Does the Use of Pre-operative SSKI Actually Reduce Vascularity and Improve Surgical Outcomes for Total Thyroidectomy in Graves' Disease?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Change in Vascular Flow From Baseline
研究概览
简要总结
The purpose of this research is to find out if SSKI (Potassium Iodide) reduces vascularity (the number and concentration of blood vessels) and improves how well patients do after surgery for removal of their whole thyroid gland in Graves' disease (an autoimmune disease that is a common cause of hyperthyroidism).
详细描述
Patients with Graves' disease and goiters tend to have very vascular thyroid glands, which increases operative bleeding risks/rates. Many surgeons treat these patients with preoperative SSKI which is believed to decrease the vascularity, which in turn may decrease bleeding risks. However, there has been no quantitative data published on whether this is a real effect with true clinical benefit, in either animal or human models with SSKI. There have been some studies in Europe studying Lugol's solution, a different formulation of iodine, which show some decreased vascularity using color Doppler or measurements of CD34 cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •individuals diagnosed with Graves' disease undergoing total thyroidectomy for cure of disease.
排除标准
- •no Graves' disease
- •< 18 years old
研究组 & 干预措施
SSKI (Potassium Iodide)
Participants randomized to receive 7 days of pre-operative SSKI
干预措施: SSKI- Potassium Iodide (Drug)
结局指标
主要结局
Change in Vascular Flow From Baseline
时间窗: From Baseline to Immediately Before Surgery
Using 3D imaging software, the investigators will quantify the vascular flow in the ultrasound images and compare baseline images with the operating room (OR) images to assess if there is a difference in vascular flow between those timepoints. Vascular flow will be quantified using percent (%) surface area. This calculation will be done by a computer algorithm.
次要结局
未报告次要终点