Autofluorescence-guided Thyroid Surgery: Impact on Parathyroid Preservation and Hypoparathyroidism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 4
- 主要终点
- Rate of hypoparathyroidism
研究概览
简要总结
Hypoparathyroidism is the most frequent complication in total thyroidectomy. The use of near-infrared autofluorescence (NIRAF) intraoperatively, seems to reduce the rate of transient hypoparathyroidism. Unfortunately, no effect on permanent hypoparathyroidism has been shown.
In order to cover every aspect of the impact of NIRAF in thyroid surgery, an evaluation in low-volume, non-parathyroid institutions is needed. This is the overall aim of our current studies. The objective of this specific study is to evaluate the impact of NIRAF on immediate, transient and permanent hypoparathyroidism following total thyroidectomy in low-volume, non-parathyroid institutions.
详细描述
Patients referred for total thyroidectomy will undergo NIRAF-assisted surgery (Fluobeam LX) at two low-volume ENT-departments with no experience in parathyroid surgery.
PTH and ionized calcium will be assessed preoperatively, on postoperative day 1 (POD1) and minimum two months following surgery. Patients who still fulfill the criteria for hypoparathyroidism at that point will be followed until one year following surgery. The rates of immediate, transient and permanent hypoparathyroidism will be assessed and compared to a historic cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patients referred for total thyroidectomy
- •Age > 18
- •Able to understand patient information
- •Able to give informed consent
排除标准
- •Previous thyroid surgery
- •Need for accelerated surgery
- •Insufficient biochemical profile
结局指标
主要结局
Rate of hypoparathyroidism
时间窗: Will be assessed on postoperative day one, minimum two months and one year following surgery.
次要结局
- Parathyroid autotransplantation rate(Will be assessed at the time of surgery)
- Parathyroid gland identification rate(Will be assessed at the time of surgery)
- Rate of inadvertently excised parathyroid glands(Will be assessed 1 month following surgery)
研究者
Ali Abood
Principal Investigator
Regional Hospital West Jutland