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临床试验/NCT00941551
NCT00941551已完成不适用

Five-year Follow up of a Randomized Clinical Trial of Unilateral Thyroid Lobectomy With or Without Levothyroxine Treatment Postoperatively

Jagiellonian University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2000年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Primary outcome measure was prevalence of recurrent goiter within the contralateral thyroid lobe

研究概览

简要总结

The aim of this study was to compare the prevalence of recurrent nodular goiter in the contralateral thyroid lobe among patients after unilateral thyroid lobectomy for unilateral multinodular goiter receiving versus not receiving prophylactic levothyroxine treatment postoperatively in a five-year follow-up of a randomized study

详细描述

It is commonly accepted that in patients with benign nodular thyroid disease who undergo operative therapy, surgical resection consists of lobectomy for patients with disease limited to one lobe. Contralateral disease is excluded in such cases by preoperative palpation, ultrasonography of the neck, and intraoperative palpation. On the other hand, the preferred operative procedure for bilateral nodular thyroid disease is total thyroidectomy. Such a treatment strategy minimizes the risk of development of recurrent disease and diminishes the risk of complications when reoperation for recurrent nodular thyroid disease becomes necessary. The recurrence rate for unilateral thyroidectomy of benign nodular goiter performed by expert surgeons has been reported to vary from 10% to 26%. Potential risk factors for recurrence of nodular goiter have been evaluated in many studies and include: young age at presentation, female gender, positive family history of goiter, long duration of symptoms, mutinodularity of thyroid disease, high volume of left thyroid tissue. However, most studies evaluating the incidence of recurrent nodular disease are retrospective, and it is difficult to determine whether the recurrence represents de novo nodule formation in a previously normal thyroid remnant or progression of residual disease left at initial operation.

It is well known fact, that most patients after thyroid lobectomy are euthyroid (60%-90%) and do not require thyroid hormone replacement therapy. However, it is an important question whether thyroid hormone administration postoperatively can prevent recurrent nodular thyroid disease in euthyroid hemithyroidectomized patients? The aim of the present randomized study was to compare the prevalence of recurrent nodular goiter in the contralateral thyroid lobe among patients after unilateral thyroid lobectomy for unilateral multinodular goiter (MNG) receiving versus not receiving prophylactic levothyroxine (LT4) treatment postoperatively in a five-year follow-up.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • unilateral multinodular goiter with normal appearing on ultrasound of the neck contralateral thyroid lobe, in a patient in euthyroid state

排除标准

  • bilateral multinodular goiter, enlargement of contralateral thyroid lobe (volume on ultrasound >10 ml), suspicion of thyroid cancer, previous thyroid surgery, thyroiditis, subclinical or clinically overt hypothyroidism or hyperthyroidism, pregnancy or lactation, age < 18 years or > 65 years, ASA 4 grade (American Society of Anesthesiology), and inability to comply with the follow-up protocol

研究组 & 干预措施

Group A

receiving levothyroxine postoperatively

干预措施: levothyroxine (Drug)

Group B

not-receiving levothyroxine postoperatively

干预措施: no levothyroxine (Drug)

结局指标

主要结局

Primary outcome measure was prevalence of recurrent goiter within the contralateral thyroid lobe

时间窗: at 3, 6, 9, 12, 24, 36, 48 and 60 months postoperatively

次要结局

  • Secondary outcome was the rate of the reoperation for the recurrent goiter(at 3, 6, 9, 12, 24, 36, 48 and 60 months postoperatively)

研究者

发起方
Jagiellonian University
申办方类型
Other

研究点 (1)

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