Peritoneal Cavity Conditioning During Open Surgery Decreases Postoperative Pain and Inflammation and Decreases Time to Restore Transit
试验速览
- 阶段
- 不适用
- 发起方
- KU Leuven
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary endpoint : decreased pain on day 1 and 2 after surgery
研究概览
简要总结
Given the observations in animal models and the available data in the human our hypothesis is that peritoneal cavity conditioning (carbon dioxide with 4% of oxygen and 10% of N2O, 100% humidification at 32°C,) during open surgery, will result in an important decrease in postoperative peritoneal inflammation, postoperative pain, and will restore bowel transit faster.
详细描述
Aim of the Trial :
RCT demonstrating that peritoneal cavity conditioning during open surgery will result in a less postoperative inflammation, less postoperative pain, and shorter time to flatus and transit.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Primary endpoint : decreased pain on day 1 and 2 after surgery
时间窗: 0 to 7 days
Postoperative pain : will be assessed by visual analog scales (cfr Trial by Verguts \& Koninckx, addendum I) assessed pain on day 1, 2 and 3 after surgery. Pain medication will be free, but preferentially ibuprofen will be used in order to permit easier comparison of pain killer intake.
次要结局
- decrease in CRP and inflammatory parameters on day 1 and 2 or longer(day 1-4)
- lower peritoneal fluid volume on day 2(day 2 after surgery)
- Shorter time to resumption of transit: time to first flatus and time to first stool(day1 to 5)