Effect of Preoperative High-dose Cholecalciferol in Prevention of Post-thyroidectomy Hypocalcaemia : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Post-operative hypocalcemia
研究概览
简要总结
Hypocalcaemia after thyroidectomy is observed with increasing frequency, often resulting in prolonged hospital stay with increased use of resources, delayed return to work and reduced quality of life. The administration of vitamin D is essential in the therapy of postoperative hypocalcaemia. What has not been examined so far is whether and how routine preoperative cholecalciferol prophylaxis can help to prevent postoperative hypocalcaemia
详细描述
Hypocalcemia following thyroid surgery is caused either due to parathyroid devascularization, stunning, or accidental removal of the parathyroid glandsMultiple risk factors have been identified which predispose patients to develop post-operative hypocalcemia. In light of the available evidence of prevalent vitamin D deficiency in the general population, and the observation of appearance of postthyroidectomy hypocalcemic symptoms at a much earlier stage than documented in previous literature, we postulate that a prophylactic vitamin D supplementation dose given in immediate preoperative period can significantly reduce acute symptomatic postoperative hypocalcemia in patients undergoing thyroid surgery
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients (> 18 years)
- •Scheduled for TT
- •Thyroid cancer treated with total thyroidectomy without lymph node dissection
排除标准
- •Lack of written consent
- •Thyroid cancer treated with TT and lymph node dissection
- •Mediastinal goiter with need for sternotomy
- •Medication with thiazide diuretics, digitalis or lithium therapy
- •Previous neck operations or radiation
- •Preexisting hyperparathyroidism
- •Chronic kidney failure.
结局指标
主要结局
Post-operative hypocalcemia
时间窗: After 6 months
The primary outcomes measure of this study was postoperative hypocalcemia based on either clinical symptoms or laboratory values.
次要结局
未报告次要终点
研究者
Mubashra Badar
Resident
Pak Emirates Military Hospital