A Prospective Randomized Controlled Trial of Lower Abdominal Three-port Laparoscopic Cholecystectomy
A Prospective Randomized Controlled Trial of Traditional Three-port Laparoscopic Cholecystectomy Versus Lower Abdominal Three-port Laparoscopic Cholecystectomy
We have designed a new method which could be used in laparoscopic cholecy- stectomy.Account to this new method, the three incisions are all located on the lower abdominal, theoretically it could get more beautiful outlook and less stress response than traditional laparoscopic cholecystectomy(two of the three incisions located on upper abdomen) or single port laparoscopic cholecystectomy(one large incision located on umbilicus).
We plan to conduct a randomized controlled trial to compare those there methods of laparoscopic cholecystectomy, in order to find out if there will be some advantages of this new method,such as in lowering the stress response,reducing impact on respiration, relieving post-operation pain and improving appearance.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Beijing
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Beijing、Beijing、中国、100029
- Department of hepatobiliary surgery,China-Japan Friendship Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- age from 18 to 70 years old
- benign diseases of gallbladder
- selective cholecystectomy
- Capable to read and write
Exclusion Criteria:
- accept upper abdominal operation before
- acute cholecystitis
- with serious heart or pulmonary diseases
- with diseases of immune system
- Pregnant women
- can not understand the research purposes
- relatives of researchers
学习计划
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：LALC
lower abdominal laparoscopic cholecystectomy
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其他名称：
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实验性的：SLC
single laparoscopic cholecystectomy
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其他名称：
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安慰剂比较：UALC
upper abdominal laparoscopic cholecystectomy
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其他名称：
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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 |
|---|---|---|
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Systematic inflammatory response caused by the surgical trauma
大体时间：one day before the operation,8 hours after the operation,one day after the operation
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Blood IL-6,TNF-α,and CRP levels determined by ELISA at different time-points,
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one day before the operation,8 hours after the operation,one day after the operation
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Cosmesis and body image score
大体时间：1 and 3 months after the operation
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1 and 3 months after the operation
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pulmonary function
大体时间：one day before the operation, one day after the operation
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one day before the operation, one day after the operation
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Post-operation pain score (visual analog scale, VAS)
大体时间：12 and 24 hours after the operation
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12 and 24 hours after the operation
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36-item health survey
大体时间：3 months after the operation
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3 months after the operation
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
perioperative indexes
大体时间：perioperative period
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operative duration,intra-operative blood loss, indication for additional trocar placement or conversion to open surgery, postoperative complications and duration of postoperative hospital stay
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perioperative period
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合作者和调查者
调查人员
- 首席研究员：Chen Wang, MD、China-Japan Friednship Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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