A Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- time of surgery
研究概览
简要总结
The primary objective of the present trial is to investigate, the mean operative time and to study the frequency and intensity of postoperative shoulder tip pain in patients undergoing laparoscopic surgery, i.e. cholecystectomy, colorectal surgery, hernia repair with AirSeal® compared with standard pressure CO2 insufflation systems. The primary hypothesis is that patients operated with AirSeal® have a shorter mean operative time and decreased frequency and intensity of postoperative shoulder tip pain compared with patients undergoing surgery with standard pressure CO2 insufflation systems.
It is the secondary objective of the trial to evaluate immunologic and anaesthesiological aspects of laparoscopic cholecystectomy, colorectal surgery and laparoscopic hernia repair by observing the immune responses and volume of mechanical ventilation of the two groups through measuring various immunologic factors and ventilation volume/CO2 elimination volume. Surgical side effects will also be measured as secondary objective.
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
- None
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
- •Patients recruited for laparoscopic surgery i.e. cholecystectomy, colorectal surgery, hernia repair
- •Written informed consent
- •≥ 18 years of age
排除标准
- •Patients with known immunological dysfunction (advanced liver disease, HIV, hepatitis C virus infection), drug addiction
- •≤18 years of age
- •Pregnancy and lactation
- •Previous extensive abdominal surgery
- •Acute surgical intervention
结局指标
主要结局
time of surgery
时间窗: one year
Time of surgery, expressed in minutes from the time of incising to suturing the skin.
shoulder pain
时间窗: one year
Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale).
次要结局
- postoperative complications(one year)
- Immunological aspects(one year)
