A Comparison of Three Different Puncture Points to Establish the Pneumoperitoneum in Laparoscopic Gastrointestinal Surgery: A Randomized Prospective Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Complications during entry in laparoscopy
研究概览
简要总结
The Palmer's point and periumbilical region are the common laparoscopic entry site to establish the pneumoperitoneum. In the present study, the investigators assess the safety and feasibility of Meng's point as a new laparoscopic entry site in cases to perform the gastrointestinal surgery.
This prospective and randomized study will compare the three entry techniques with regard to:
- Complications related to the entry technique
- Time taken to enter the abdomen.
- The number of attempts taken to enter the abdomen
详细描述
Patients of China-Japan Friendship Hospital that are having a laparoscopic surgery for general surgery purposes will participate in the study. Patients with previous abdominal surgeries will be excluded from the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will be randomized into the three arms of the trial. All patient information will be confidential and only be available to researches involved in the study. Only one attending surgeon of the General Surgery Department of China-Japan Friendship Hospital will participate in the study. 90 patients will be recruited over one year period and the data will be analysed by a statistician.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient suitable for laparoscopic abdominal surgery
排除标准
- •previous abdominal surgeries
研究组 & 干预措施
Meng's Point entry
Meng's entry involved a 0.2 cm horizontal or vertical incision using the Veress needle in the cross of lateral border of the left rectus abdominis and rib arch.
干预措施: Veress needle (Device)
Palmer's Point entry
Palmer's entry involved a 0.2 cm horizontal or vertical incision with the Veress needle in the left midclavicular line approximately 3 cm caudal to the 10th rib
干预措施: Veress needle (Device)
Periumbilllicus entry
Periumbilllicus entry involved a 0.2 cm horizontal or vertical midline incision using the Veress needle in the lower or uper border of the umbilicus.
干预措施: Veress needle (Device)
结局指标
主要结局
Complications during entry in laparoscopy
时间窗: During surgery
次要结局
- Time to enter in the abdominal cavity(During surgery)
研究者
Fanqiang Meng
MD. PhD.
China-Japan Friendship Hospital