跳至主要内容
临床试验/NCT00731107
NCT00731107Unknown不适用

XCEL Bladeless Trocar Versus Veress Needle: A Randomised Controlled Trial Comparing These Two Entry Techniques in Gynaecological Laparoscopic Surgery.

Southern Health2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2008年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
2
主要终点
Primary out come measure is time to entry in laparoscopic surgery

研究概览

简要总结

The method most commonly used to gain entry to the abdomen in laparoscopic surgery (minimally invasive surgery) amongst gynecologists is the Veress Needle. This needle is inserted, usually near the belly button, before adding gas to the abdomen. With a pressurised abdomen a sharp trocar is then inserted to hold the operating telescope.

The XCEL bladeless trocar is another method of inserting the operating telescope whereby you don't need to first introduce gas before the trocar. This trocar is widely used in laparoscopic surgery but it is uncommon to the field of gynecology.

This study will compare the two methods with regard to:

  1. Time taken to enter the abdomen
  2. The number of attempts taken to enter the abdomen
  3. The impact of the time taken to enter compared to the whole operating time
  4. The happiness that the surgeon has entered the abdomen before adding gas, on a scale of 1 to 5.

Patients will be recruited into the trial through the Monash Medical Centre Gynecology department and the Mercy Hospital for Women Gynecology department. Patients that are having laparoscopic surgery and would usually have a Veress Needle entry are suitable for this trial. A patient information sheet will be provided and written consent will then be obtained. Patients who give written consent will be randomised into one of two arms of the trial, either the control (Veress Needle) or the XCEL bladeless trocar arm.

Information will be entered on a proforma by a researcher for each patient during their operation. All patient information will be strictly confidential and only be available to researchers directly involved in the study.

Surgeons operating as part of the project are the consultants and fellow of the gynecology department of Monash Medical Centre and Mercy Hospital for Women and are competent in both techniques.

200 women will be recruited over a one year period and the data will then be analysed with the help of 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
Single (Participant)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Any woman having a Veress Needle laparoscopy through the Southern Health and Mercy Hospital for Women gynecology departments

排除标准

  • Any women considered not eligible for a Veress Needle laparoscopy

结局指标

主要结局

Primary out come measure is time to entry in laparoscopic surgery

时间窗: 1 year

次要结局

  • number of attempts at entry in laparoscopic surgery(1 year)

研究者

发起方
Southern Health
申办方类型
Other

研究点 (2)

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