Comparing the Quality of Life Associated With Empiric Calcium Repletion and Parathormone (PTH) Based Calcium Repletion for Post Thyroidectomy Hypoparathyroidism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change from baseline quality of life at 1 and 4 weeks
研究概览
简要总结
This study aims to compare two different protocols commonly used in the management of post thyroidectomy hypoparathyroidism : PTH based calcium repletion and empiric repletion. The investigators aim to compare the quality of life associated with these two protocols in a randomized trial.
详细描述
Enrolled patients will be randomized in two treatment groups. In group 1, all patients will receive calcium carbonate and calcitriol in the post-operative period, with standardized weaning. In group 2, patients will be prescribed calcium carbonate and calcitriol only if their post-operative PTH dosage is 25% or less of the pre-operative dosage, or if post-operative PTH is inferior to 15.
The Short-Form 36 (SF-36) questionnaire (French canadian version) will be used to assess quality of life pre-operatively and at post-op week 1 and 4. Symptoms of hypocalcemia and adverse effects of calcium carbonate and calcitriol will be monitored at week 1 and 4.
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
- 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
- •Total thyroidectomy or completion hemithyroidectomy
排除标准
- •Need for neck dissection
- •Unable to fill in questionnaires (intellectual deficit, severe psychiatric disorder, illiterate, does not speak French or English)
结局指标
主要结局
Change from baseline quality of life at 1 and 4 weeks
时间窗: Pre-op, 1 week post-op and 4 weeks post-op
Short Form 36 (SF-36) questionnaire
次要结局
- Occurence and change in pharmacologic adverse effects of calcium carbonate and calcitriol(1 week post-op, 4 weeks post-op)
- Occurence and change in symptoms of hypocalcemia(1 week post-op, 4 weeks post-op)
研究者
Jean-Philippe Vézina
Otolaryngologist and Head & Neck Surgeon
CHU de Quebec-Universite Laval