Classic Total Thyroidectomy With or Without Drains
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Assess the necessity of the use of drains in large goiters
研究概览
简要总结
Protocol Synopsis
- Design: Prospective, single-center randomized study Patient Population: Male or female subjects 18 years of age or older who are scheduled for total thyroidectomy
- No. of Subjects: 100 patients divided into two groups, estimated up to 6 months to enroll
- Duration of Treatment: During the operation
- Duration of Follow-up: Follow-up will be performed daily while hospitalized, and by phone till the 7th postoperative day
- Endpoints: To evaluate the safety and cost-effectiveness 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 total thyroidectomy (TT). 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 TT 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 TT is considered today, the golden standard of total thyroid resection.
This protocol is designed to compare data in regards to TT with drains versus TT without drains.
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 thyroid operation
- •Patient is participating in another clinical trial which may affect this study's outcomes
- •Patient in toxic condition
- •Patient receiving anticoagulation treatment for other medical condition
研究组 & 干预措施
B
Classic thyroidectomy without drains
干预措施: Total thyroidectomy (Procedure)
A
Classic thyroidectomy with drains
干预措施: Total thyroidectomy (Procedure)
结局指标
主要结局
Assess the necessity of the use of drains in large goiters
时间窗: 7days
次要结局
未报告次要终点