跳至主要内容
临床试验/CTRI/2022/03/040913
CTRI/2022/03/040913尚未招募不适用

Use of sub capsular saline injection during thyroid surgery to preserveparathyroid function.

not applicable1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2022年3月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
320
试验地点
1
主要终点
To assess the efficacy of Subcapsular saline injection (SCASI) in reducing the rate of

研究概览

简要总结

Thyroidectomy is the most common elective endocrine surgical procedures performed worldwide. Total thyroidectomy is the treatment of choice for both benign and malignant thyroid diseases. The incidence of post-operative hypocalcemia varies from 1.6 – 50% and is caused due to inadvertent removal, mechanical or thermal injury to the parathyroid glands. With improved knowledge of the variations in the position and vascular anatomy of the parathyroid glands, this has resulted in a significant reduction in the incidence of postoperative hypoparathyroidism. However, symptomatic hypocalcemia continues to be one of the leading causes of post thyroidectomy morbidity and can result in psychological and emotional disturbances, prolonged hospital stay and additional financial burden.Various procedures such as preservation of the inferior thyroid vein, parathyroid autotransplantation, and the use of angiography with indocyanine green, carbon nanoparticles, or a gamma probe to identify the parathyroid glands has been tested to reduce the frequency of hypoparathyroidism after total thyroidectomy. However, careful dissection of parathyroid gland by avoiding mechanical and thermal injury remains the mainstay to prevent postoperative hypoparathyroidism. There are only two studies which have demonstrated the efficacy of subcapsular injection of saline during thyroid surgery to reduce post-operative hypoparathyroidism, however with small sample sizes. This aim of our study is to evaluate the efficacy of subcapsular injection of saline (SCASI) during thyroid surgery to reduce post-operative hypoparathyroidism by reducing mechanical and thermal injury during dissection of the parathyroid gland compared with standard thyroidectomy.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients admitted for a total thyroidectomy with or without a neck dissection.

排除标准

  • Patients undergoing less than total thyroidectomy
  • Previous neck, thyroid and parathyroid surgeries
  • Concurrent parathyroid disease
  • Previous received ablative dose of I-131.

结局指标

主要结局

To assess the efficacy of Subcapsular saline injection (SCASI) in reducing the rate of

时间窗: Immediate postop day 1 and 6 months later

post-thyroidectomy hypocalcemia and hypoparathyroidism.

时间窗: Immediate postop day 1 and 6 months later

次要结局

  • Not applicable(Not applicable)

研究者

申办方类型
Other [Not applicable]

研究点 (1)

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