Incidence of Postoperative and Long Term Hypocalcemia After Indocyanine Green Fluorescence Guided V/S Conventional Assessment of Parathyroid Function Following Total Thyroidectomy- A randomised control trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Assessment of Parathyroid function and resultant post operative and long term Hypocalcemia in Indocyanine Green Fluorescence Guided V/S Conventional Assessment of Parathyroid Function Following Total Thyroidectomy
研究概览
简要总结
Identification of parathyroidglands is one of the main concerns in thyroid surgery. It is usually verydifficult to distinguish parathyroid glands from thyroid and surroundingtissues in the neck due to their small size and variable location. Thepercentage of incidental parathyroidectomies is around 16% The incidence rateof hypocalcemia can reach up to 4.5% in total thyroidectomies rising to 11.5%in thyroidectomies with central node dissection. These rates can increase to50% for transient hypocalcemia and 13.8% for permanent hypocalcemia in totalthyroidectomies. The main cause of hypocalcaemia after total thyroidectomy ishypoparathyroidism due to intraoperative damage to the parathyroid glands bytrauma, inadvertent parathyroid gland removal or devascularization. The extentof damage to the parathyroid glands is difficult to predict during surgery. Thefeasibility of ICG in assessing the parathyroid gland function in patientsundergoing thyroidectomy and thereby preventing postoperative hypocalcemia isbeing compared with our conventional methods in this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
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
- •1.Patients with known renal impairment or iodine allergy 2.Patients with concomitant hyperparathyroidism 3.Age< 18 years Age > 70 years 4.Pregnancy 5.Patients undergoing central compartment neck dissection or modified radical neck dissection.
结局指标
主要结局
Assessment of Parathyroid function and resultant post operative and long term Hypocalcemia in Indocyanine Green Fluorescence Guided V/S Conventional Assessment of Parathyroid Function Following Total Thyroidectomy
时间窗: Post operative Day 1, 3 months and 6 months
次要结局
- Treatment for Hypocalcemia in patients undergoing Total Thyroidectomy(Post operative Day 1, 3 months and 6 months)