跳至主要内容
临床试验/NCT00946894
NCT00946894已完成不适用

Five-year Follow up of a Randomized Clinical Trial of Total Thyroidectomy Versus Dunhill Operation Versus Bilateral Subtotal Thyroidectomy for Multinodular Non-toxic Goiter.

Jagiellonian University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2000年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
试验地点
1
主要终点
Primary outcome measure was prevalence of recurrent goiter and need for redo surgery.

研究概览

简要总结

The aim of this three-arm randomized study was to evaluate results of different thyroid resection modes among patients with bilateral multinodular non-toxic goiter, with special emphasis put on recurrence rate and morbidity rate, in a 5-year follow-up.

详细描述

The extent of thyroid resection in bilateral multinodular non-toxic goiter remains controversial. Surgeons still continue to debate whether the potential benefits of total thyroidectomy outweigh the potential complications. Most low-volume surgeons avoid to perform total thyroidectomy owing to the possible complications such as permanent recurrent laryngeal nerve palsy and permanent hypoparathyroidism. On the other hand, the increasing number of total thyroidectomies are currently performed in high-volume endocrine surgery units, and the indication for this procedure include thyroid cancer, Graves disease and multinodular goiter. Recently there has been increasing acceptance for performing total thyroidectomy for bilateral multinodular non-toxic goiter as it removes the disease process completely, lowers local recurrence rate and avoids the substantial risk of reoperative surgery, and involves only a minimal risk of morbidity. This common perception is based largely on single-institution retrospective data, a few multi-institutional retrospective experiences, and only a few prospective randomized studies comparing the outcomes of total vs. subtotal thyroidectomy.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Inclusion Criterion
  • •a bilateral non-toxic multinodular goiter with normal appearing on ultrasound of the neck posterior aspects of both thyroid lobes.

排除标准

  • •multinodular goiter involving posterior aspect/s of thyroid lobe/s,
  • •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),
  • •inability to comply with the follow-up protocol.

研究组 & 干预措施

Total thyroidectomy

Experimental

Patients who underwent total thyroidectomy

干预措施: Total thyroidectomy (Procedure)

Dunhill operation

Experimental

Patients who underwent unilateral total thyroid lobectomy and contralateral subtotal thyroid lobectomy

干预措施: Dunhill operation (Procedure)

Bilateral subtotal thyroidectomy

Active Comparator

Patients who underwent bilateral subtotal thyroidectomy

干预措施: Bilateral subtotal thyroidectomy (Procedure)

结局指标

主要结局

Primary outcome measure was prevalence of recurrent goiter and need for redo surgery.

时间窗: at 12, 24, 36, 48 and 60 months after surgery

次要结局

  • Secondary outcome measure was postoperative morbidity rate (hypoparathyroidism and recurrent laryngeal nerve injury).(at 3, 6, 9, 12, 24, 36, 48 and 60 months after surgery)

研究者

发起方
Jagiellonian University
申办方类型
Other

研究点 (1)

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