Incidence of postoperative hypocalcemia after Indocyanine Green fluorescence guided v/s Conventional assessment of parathyroid function following total thyroidectomy - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 2. To compare the incidence of postoperative hypocalcemia after ICG guided assessment of parathyroid function with that of conventional methods
研究概览
简要总结
Identification of parathyroid glands is one of the main concerns in thyroid surgery. It is usually very difficult to distinguish parathyroid glands from thyroid and surrounding tissues in the neck due to their small size and variable location. The percentage of incidental parathyroidectomies is around 16% The incidence rate of hypocalcemia can reach up to 4.5% in total thyroidectomies rising to 11.5% in thyroidectomies with central node dissection. These rates can increase to 50% for transient hypocalcemia and 13.8% for permanent hypocalcemia in total thyroidectomies. The main cause of hypocalcaemia after total thyroidectomy is hypoparathyroidism due to intraoperative damage to the parathyroid glands by trauma, inadvertent parathyroid gland removal or devascularization. The extent of damage to the parathyroid glands is difficult to predict during surgery. The feasibility of ICG in assessing the parathyroid gland function in patients undergoing thyroidectomy and thereby preventing postoperative hypocalcemia is being compared with our conventional methods in this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All Patients undergoing total thyroidectomy for both benign and malignant conditions.
排除标准
- •Patients with known renal impairment or iodine allergy
- •Patients with concomitant hyperparathyroidism
- •Age< 18 years Age > 70 years
- •Pregnancy
- •Patients undergoing central compartment neck dissection or modified radical neck dissection.
结局指标
主要结局
2. To compare the incidence of postoperative hypocalcemia after ICG guided assessment of parathyroid function with that of conventional methods
时间窗: Postoperative Day 0 and postoperative day 1
1. To evaluate the use of ICG angiography to assess parathyroid gland function after thyroid surgery and thereby, take appropriate steps to prevent postoperative hypocalcemia
时间窗: Postoperative Day 0 and postoperative day 1
次要结局
- To find the correlation between parathyroid fluorescence after ICG dye injection and POD0 and POD1 calcium levels and POD1 PTH levels(Postoperative day 0 and postoperative day 1)