Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery , a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Complications during entry in laparoscopy
研究概览
简要总结
The Veress needle is the laparoscopic entry technique most commonly used among gynecologists. Direct trocar entry is another method to gain entry to the abdomen that is uncommon to gynecologists.
This prospective and randomized study will compare the two entry techniques with regard to:
- Complications related to the entry technique and previous surgeries
- Time taken to enter the abdomen
- The number of attempts taken to enter the abdomen
详细描述
Patients of Dexeus Universitary Institute that are having a laparoscopic surgery for gynecological purposes will participate in the study. Patients with previous middle laparotomies or 3 or more abdominal suregeries 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 two arms of the trial. All patient information will be confidential and only be available to researches involved in the study.
Only three expert surgeons of the Gynecological Department of Dexeus Universitary Institute will participate in the study.
300 women will be recruited over a two 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Any woman suitable for laparoscopic gyneacological surgery
排除标准
- •Previus supra-infra umbilical laparotomy
- •three or more previous abdominal surgeries
结局指标
主要结局
Complications during entry in laparoscopy
时间窗: During surgery
Complications during entry in laparoscopy like vascular injury, bowel injury,conversion to laparotomy, omental injury, etc
次要结局
- Time to enter in the abdominal cavity(During surgery)
研究者
Ignacio Rodriguez MSc
Epidemilolgy
Institut Universitari Dexeus