Study on the Application of Convenient Foot-control Exhaust Method in Endoscopic Thyroidectomy
2018年9月17日 更新者：Bo Wang,MD
Endoscopic thyroidectomy developed rapidly in recent years, and the most popular surgical approach was endoscopic thyroidectomy by bilateral areola approach, but some operative steps was required optimization.
One of the most annoying problem was the smog blurring endoscopic lens during surgery.
The researcher summarized a set of convenient foot-control exhaust method and carried out this prospective study.
研究概览
地位
未知
详细说明
The patients with papillary thyroid microcarcinoma were included according to the inclusive criteria and randomly divided them into two groups (foot-control exhaust group and direct exhaust group).
The foot-control exhaust group used the foot-control exhaust method by the way of adjustable Pressure to intermittent exhaust, while direct exhaust group exhaust through the Trocar hole.
Comparison of operation time, times of wiping the endoscopic lens, volume of postoperative drainage, and number of identified parathyroid gland between two groups.
研究类型
介入性
注册 (预期的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Fujian
-
Fuzhou、Fujian、中国、350001
- 招聘中
- Wen-xin ZHAO
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients with maximum tumor diameter ≤1 cm;
- patients without lateral neck lymph node metastases;
- patients without distant metastases;
- patients who only needed unilateral surgery following the guidelines;
- patients with strong cosmetic requirement.
Exclusion criteria:
- Patients with maximum tumor diameter >1 cm;
- patients who needed complement total thyroidectomy according to the guidelines, including tumor extrathyroidal extension as well as large amount of neck lymph node metastases and distant metastases;
- patients without cosmetic requirements.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：foot-control exhaust group
The foot-control exhaust group used of the Pressure adjustable foot-control method by the way of adjustable Pressure to intermittent exhaust
|
Whether The Pressure adjustable foot-control method is used.
|
|
安慰剂比较：direct exhaust group
direct exhaust group exhaust through the Trocar hole.and
without use of the Pressure adjustable foot-control method
|
direct exhaust through the trocar.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Flap separation time
大体时间：1 day after surgery
|
Flap separation time was acquired from endoscopic video was the period from endoscopy into the body to building up operation space.
|
1 day after surgery
|
|
Glandular excision time
大体时间：1 day after surgery
|
Glandular excision time was defined from incising cervical white line to removing Berry ligament.
|
1 day after surgery
|
|
Central lymph node dissection time
大体时间：1 day after surgery
|
Central lymph node dissection time: was from separating central lymph node to the specimen removed.
|
1 day after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Times of wiping lens
大体时间：1 day after surgery
|
Times of wiping lens calculated from endoscopic video after operation was defined the times of wiping lens from endoscopy into the body to central lymph node removed.
|
1 day after surgery
|
|
Volume of intraoperative blood loss
大体时间：1 day after surgery
|
Volume of intraoperative blood loss was estimated the volume of intraoperative blood loss.
|
1 day after surgery
|
|
Volume of Postoperative drainage
大体时间：1 day，2 day，3 day after surgery
|
Volume of Postoperative drainage was accurately calculated the total volume while the drainage tube removed after operation.
|
1 day，2 day，3 day after surgery
|
|
The number of identifying parathyroid glands
大体时间：1 day after surgery
|
The number of identifying parathyroid glands was evaluated at postoperation while parathyroid glands was identified during surgery.
|
1 day after surgery
|
|
Blood PTH level
大体时间：preoperative, first day after operation, one week after surgery, two months after surgery.
|
measurement of PTH level in blood
|
preoperative, first day after operation, one week after surgery, two months after surgery.
|
|
Blood calcium level
大体时间：before surgery, the first day after surgery, one week after surgery, two months after surgery.
|
to measure the blood calcium level in the blood
|
before surgery, the first day after surgery, one week after surgery, two months after surgery.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年1月1日
初级完成 (实际的)
2018年6月30日
研究完成 (预期的)
2018年12月30日
研究注册日期
首次提交
2018年1月19日
首先提交符合 QC 标准的
2018年1月25日
首次发布 (实际的)
2018年1月26日
研究记录更新
最后更新发布 (实际的)
2018年9月18日
上次提交的符合 QC 标准的更新
2018年9月17日
最后验证
2018年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.