Early Prediction of Hypocalcaemia Following Thyroid Surgery: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Sensibility and specificity of iPTH and serum calcium measurement
研究概览
简要总结
150 patients divided into two groups.The experimental group was submitted at the assay of iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum calcium and phosphorus.
详细描述
Purpose: The aim of this randomized controlled trial was to validate the results of a previous prospective cohort study conducted in the same surgical unit regarding the use of concomitant intact parathyroid hormone (iPTH) and serum calcium measurement in predicting hypocalcemia after total thyroidectomy.
Methods: From January 2014 to January 2015, 150 patients underwent total thyroidectomy in our department and were divided into two groups. The experimental group was submitted at the assay of iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum calcium and phosphorus. Sensitivity and specificity of different serum measurements have been calculated using the Receiver-operator characteristics (ROC) curve.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be submitted to total thyroidectomy during the study period
- •Have signed the informed consent
排除标准
- •Lack of inclusion criteria
- •Lobectomy with isthmusectomy or partial or subtotal thyroidectomy
- •Completion thyroidectomy
- •Concomitant hyperparathyroidism was present
- •Concomitant treatment with oral calcium and/or vitamin D prior to surgery
结局指标
主要结局
Sensibility and specificity of iPTH and serum calcium measurement
时间窗: 1 month
Sensitivity and specificity of serum measurement using the Receiver-operator characteristics (ROC) curve
次要结局
未报告次要终点
研究者
Alessandra Saba
Doctor
University of Cagliari