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临床试验/NCT01740011
NCT01740011已完成不适用

A Prospective Randomized Trial on Comparison of Standard- Carbon Dioxide Pressure Pneumoperitoneum Insufflators Versus AirSeal

Krankenhaus Barmherzige Schwestern Linz2 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
182
试验地点
2
主要终点
time of surgery

研究概览

简要总结

The primary objective of the present trial is to investigate, the mean operative time and to study the frequency and intensity of postoperative shoulder tip pain in patients undergoing laparoscopic surgery, i.e. cholecystectomy, colorectal surgery, hernia repair with AirSeal® compared with standard pressure CO2 insufflation systems. The primary hypothesis is that patients operated with AirSeal® have a shorter mean operative time and decreased frequency and intensity of postoperative shoulder tip pain compared with patients undergoing surgery with standard pressure CO2 insufflation systems.

It is the secondary objective of the trial to evaluate immunologic and anaesthesiological aspects of laparoscopic cholecystectomy, colorectal surgery and laparoscopic hernia repair by observing the immune responses and volume of mechanical ventilation of the two groups through measuring various immunologic factors and ventilation volume/CO2 elimination volume. Surgical side effects will also be measured as secondary objective.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients recruited for laparoscopic surgery i.e. cholecystectomy, colorectal surgery, hernia repair
  • Written informed consent
  • ≥ 18 years of age

排除标准

  • Patients with known immunological dysfunction (advanced liver disease, HIV, hepatitis C virus infection), drug addiction
  • ≤18 years of age
  • Pregnancy and lactation
  • Previous extensive abdominal surgery
  • Acute surgical intervention

结局指标

主要结局

time of surgery

时间窗: one year

Time of surgery, expressed in minutes from the time of incising to suturing the skin.

shoulder pain

时间窗: one year

Postoperative shoulder tip pain assessed by the Visual Analogue Scale of Pain (VAS scale).

次要结局

  • postoperative complications(one year)
  • Immunological aspects(one year)

研究者

发起方
Krankenhaus Barmherzige Schwestern Linz
申办方类型
Other
责任方
Sponsor

研究点 (2)

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