The Relationship Between the Removing Port of the Laparoscopic Cholecystectomy Material and the Port Site Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Port site infections
研究概览
简要总结
Laparoscopic cholecystectomy is gold standard for gallstones. In this study the investigators are investigating the effect of the removing of cholecystectomy material from different ports, to the port site infections.
详细描述
Laparoscopic cholecystectomy is gold standard for gallstones. But there is no consensus about which port place is optimal for the removing of the cholecystectomy material from the abdomen. There are different port site infections rates in the literature. The minimal tissue damage of laparoscopic cholecystectomy suggests a lower risk of wound infection, but there are series with an infection range of 8 %. The investigators are investigating is there any difference at the port site infection rates when the cholecystectomy material removed from different ports from the abdomen at the laparoscopic cholecystectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has cholelithiasis
排除标准
- •Subject has perforated gallbladder
- •Subject has malignancy
- •Subject has increasing wall thickness of the gallbladder
- •Subject has malignancy in the preoperative ultrasonography in the gallbladder
- •Subject has pregnancy
研究组 & 干预措施
Umbilical
The cholecystectomy material will be removed from umbilical port as usual. This will be control group. Port site infection rates will be measured.
Epigastric
The cholecystectomy material will be removed from epigastric port. This will be experimental group. Port site infection rates will be measured.
干预措施: Removing from Epigastric port (Procedure)
结局指标
主要结局
Port site infections
时间窗: 2 days
The cholecystectomy material will be removed from umbilical port at the control group, from the epigastric port at the experimental group. The port site infection rates will be noted.
次要结局
未报告次要终点
研究者
Ufuk Oguz Idiz
M.D.
Sisli Hamidiye Etfal Training and Research Hospital