Late Postoperative Course of Patients With Mini Video Assisted Thyroidectomy (miVAT) Versus Classic Thyroidectomy (T)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Comparison of the late postoperative course and complications of the patients using the two techniques
研究概览
简要总结
Protocol Synopsis
- Protocol title: Late postoperative course of patients with mini Video Assisted Thyroidectomy (miVAT) versus classic Thyroidectomy (T)
- Purpose: Comparison of the late postoperative course and complications of the patients using the two techniques
- Design: Prospective, single-center randomized study
- Patient Population: Male or female subjects 18 years of age or older with nodular goiter who are scheduled for total thyroidectomy (miVAT or T)
- No. of Subjects: 100 patients divided into two groups, estimated up to 1 year to enroll
- Duration of Treatment: During the operation
- Duration of Follow-up: Follow-up will be performed by evaluation at the 3rd and 6th postoperative month ±5 days
- Endpoints: To evaluate the long term safety of each technique
详细描述
1.0 INTRODUCTION
Classic articles by Kocher, Halsted, Lahey, Crile and Riddell have provided surgeons with principles that have significantly reduced operative morbidity and mortality from thyroidectomy. Nowadays, surgery of the thyroid gland is considered safe with practically null mortality. Morbidity, although infrequent, is still a reason for concern. The complications directly attributed to total thyroidectomy are hypoparathyroidism, recurrent laryngeal nerve injury, hemorrhage, oesophageal perforation and trachea instability and perforation. Furthermore, other complications, related to the surgical technique, such as seroma or wound infection, may also occur.
Several techniques are employed in order to resect the suffering thyroid gland. Classic thyroidectomy (T) is considered today, the golden standard of total thyroid resection for nodular goiter. One the other hand, new technologies and great experience of several surgeons gave recently birth to a new technique named mini Video Assisted Thyroidectomy (miVAT).
This protocol is designed to compare data in regards to T versus miVAT in the late postoperative period.
2.0 OBJECTIVES
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is over 18 years old
- •Patient scheduled for a non-emergency operation
- •Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures
排除标准
- •Patient had a previous operation at the thyroid
- •Patient is participating in another clinical trial which may affect this study's outcomes
- •Patient in toxic condition (non euthyroid or hypothyroid )
- •Patient receiving anticoagulation treatment for other medical condition
- •Echographic evidence that the size at least one nodule is more than 4cm
结局指标
主要结局
Comparison of the late postoperative course and complications of the patients using the two techniques
时间窗: 6months
次要结局
未报告次要终点
研究者
Papavramidis Theodossis
Elected lecturer
Aristotle University Of Thessaloniki