A Prospective Randomized Controlled Trial of Traditional Three-port Laparoscopic Cholecystectomy Versus Lower Abdominal Three-port Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Systematic inflammatory response caused by the surgical trauma
研究概览
简要总结
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 18 to 70 years old
- •benign diseases of gallbladder
- •selective cholecystectomy
- •Capable to read and write
排除标准
- •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
结局指标
主要结局
Systematic inflammatory response caused by the surgical trauma
时间窗: one day before the operation,8 hours after the operation,one day after the operation
Blood IL-6,TNF-α,and CRP levels determined by ELISA at different time-points,
次要结局
- pulmonary function(one day before the operation, one day after the operation)
- Cosmesis and body image score(1 and 3 months after the operation)
- Post-operation pain score (visual analog scale, VAS)(12 and 24 hours after the operation)
- 36-item health survey(3 months after the operation)
研究者
Li Xu
Department of hepatobiliary surgery
China-Japan Friendship Hospital