Preoperative Lugol's Solution in Graves' Disease and Toxic Nodular Goiter
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Temporary hypoparathyroidism
研究概览
简要总结
The purpose of this study is to assess if preoperative treatment with Lugol's solution prior to thyroidectomy can reduce the surgical complications hypoparathyroidism and laryngeal nerve palsy
详细描述
Current practice in Sweden before thyroidectomy due to hyperthyroidism is preoperative treatment with antithyroid drugs (ATD) to all patients with Graves' disease and in cases of toxic nodular goiter with pronounced hyperthyroidism. Iodine solution is administered preoperatively in selected cases of Graves' disease where ATD is intolerable. In the cases where iodine is used it is in the form of extemporaneous prepared iodine potassium iodide solution (Lugol 5%). The dose varies in clinical studies. In American and Swedish guidelines the dose is 5-10 drops 3 times per day for 10 days prior to surgery. American guidelines recommend iodine as preoperative treatment i Graves' disease but this is based on sparse evidence. Iodine as preoperative treatment in toxic nodular goiter has yet not been studied.
The purpose of this study is to assess if preoperative treatment with Lugol's solution prior to thyroidectomy due to hyperthyroidism reduce the surgical complications hypoparathyroidism and laryngeal nerve palsy.
Before including toxic nodular goiters accepted for surgery, a pilot study will be performed on 20 patients with toxic nodular goiter. They will receive Lugol solution 3 times per day for ten days and thyroid hormone levels will be measured day 0, day 3-4, day 6-7 and after 10 days of Lugol treatment. Heart rate assessed and ThyPRO39 filled out before and after treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hyperthyroidism accepted for thyroidectomy due to toxic nodular goiter with free T4 <30 pmol/L or Graves' disease
- •Signed informed consent
排除标准
- •Unstable coronary artery disease
- •Previous thyroid surgery
- •Congestive heart failure
- •Renal insufficiency
- •Hepatic failure
- •Current infection
- •Treatment with steroids or anticoagulants
- •Thyroid associated orbitopathy CAS > 2
- •Diabetes mellitus type 1
- •Active cancer
- •Severe psychiatric illness
- •Amiodarone treatment
- •Pregnancy
- •Breast feeding
- •Women of child bearing potential not using contraceptive
- •Inability to comprehend the meaning of the study
- •Iodine hypersensitivity
研究组 & 干预措施
Iodine Potassium Iodide solution
Participants receive Iodine Potassium Iodide solution oral drops 3 times per day for 10 Days prior to thyroidectomy in addition to standard preoperative treatment
干预措施: Iodine-Potassium Iodide 5%-10% Oral and Topical Solution (Drug)
No intervention
Participants continue with standard preoperative treatment
结局指标
主要结局
Temporary hypoparathyroidism
时间窗: 1 month postoperatively
Numbers of participants with signs of hypoparathyroidism measured as hypocalcemia, low parathormone (PTH), supplementation with per oral vitamin D or calcium.
次要结局
- Temporary laryngeal nerve palsy(1 month postoperatively)
- Permanent laryngeal nerve palsy(6 months postoperatively)
- Permanent hypoparathyroidism(6 months postoperatively)
研究者
Jan Calissendorff
MD, Senior Consultant, PhD, Associate Professor
Karolinska University Hospital