Preoperative Administration of Lugols Solution in Toxic Thyroid Diseases (TD): A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Thyroidectomy complications rate
研究概览
简要总结
Lugol's solution and other preparations containing iodide have been used as an adjuvant treatment in patients with toxic disease planned for thyroidectomy. However, no conclusive evidence supporting the benefits of preoperative treatment with LS for patients with toxic goiters. This trial aims to provide new insights into future recommendations.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients ≥18 years of age
- •Toxic thyroid disease, treated with antithyroid drugs, euthyroid and proposed for total thyroidectomy
- •Written informed consent
排除标准
- •prior thyroid or parathyroid surgery,
- •hyperparathyroidism that requires associated parathyroidectomy,
- •thyroid cancer that requires adding a lymph node dissection,
- •iodine allergy,
- •consumption of lithium or amiodarone,
- •medically unfit patients (ASA-IV),
- •breastfeeding women,
- •preoperative vocal cord palsy and
- •planned endoscopic, video-assisted or remote access surgery.
研究组 & 干预措施
Thyroidectomy without lugols solution preparation
euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, no preoperative preparation with 5% lugols solution
Thyroidectomy with lugols solution preparation
euthyroid patients undergoing total thyroidectomy for toxic thyroid disease, preoperative preparation with 5% lugols solution for 10 days
干预措施: Lugol's iodine solution 5% (Dietary Supplement)
结局指标
主要结局
Thyroidectomy complications rate
时间窗: 24 hours postoperatively
postoperative bleeding, hypoparathyroidism and recurrent laryngeal nerve palsy will be recorded
次要结局
- Interleukin-16 serum levels(Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.)
- Fibrinogen(Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.)
- Vascular endothelial growth factor(Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.)
- Thromboelastography(Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.)
- Thyroid volume(Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.)
- Superior thyroid artery blood flow(Pre-intervention and immediately after the intervention for the lugols solution group. Only preoperative measurement for the non lugols solutiongroup.)
研究者
Styliani Konstantinos Laskou
Principal Investigator
Aristotle University Of Thessaloniki