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临床试验/NCT00678366
NCT00678366已完成3 期

Evaluation of Adding Small Amounts of Oxygen to the CO2 Pneumoperitoneum Upon Pain and Inflammation

University Hospital, Gasthuisberg2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年5月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
to check if the post-operative pain and inflammatory reaction after laparoscopy decreases when CO2 with the addition of 4% of oxygen is used instead of pure CO2

研究概览

简要总结

The study intends to investigate the use of a novel gaz-composition used during laparoscopy upon pain and inflammation in the post-operative period.

详细描述

Laparoscopic surgery was introduced by gynaecologists in a search for a minimally invasive surgical approach. Laparoscopy is now generally accepted and widely used in different medical fields (gynaecology, digestive surgery, oncology, etc.,.).

  1. CO2 pneumoperitoneum and pain:

Carbon dioxide is generally used to induce and maintain a pneumoperitoneum. Following a diagnostic procedure post-operative pain is generally low. For more extensive laparoscopic surgery, pain is related to the type of surgery. It has been suggested that pain also increases with the duration of surgery. 2. CO2 pneumoperitoneum and inflammation Different immune mediators were already evaluated during laparoscopic surgery. On peripheral blood interleukin-6, C-reactive protein, tumor necrosis factor, interleukin-1, histamine response, total leukocyte counts and T-lymphocyte populations, delayed-type hypersensitivity and neutrophils activation and function were evaluated. Local peritoneal host defences such as macrophage activation and function and leukocyte function have also been studied.

Laparoscopic surgery is associated with less post-operative inflammatory reaction and less immune activation then laparotomy. (1-2).

The degree of alteration in C-reactive proteins was noted to be a 5 fold increase after laparoscopic cholecystectomy (3).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • The subject has signed a written informed consent to participate in the study and has agreed to follow instructions and complete all required questionnaires
  • Females, 18 years of age or older
  • She has to undergo a planned laparoscopy for mentioned indications with a duration that exceeds 60 minutes

排除标准

  • Pregnancy
  • Immunodeficiency
  • Refuse or unable to sign informed consent
  • Chronic diseases (i.e. COPD, Crohn, cardiac...)
  • Mental diseases

结局指标

主要结局

to check if the post-operative pain and inflammatory reaction after laparoscopy decreases when CO2 with the addition of 4% of oxygen is used instead of pure CO2

时间窗: 1 week

次要结局

  • the effects on CO2 resorbtion, pain and inflammation by co-variables: body mass index, length of surgery, painkiller intake and pain before surgery as defined by the Biberoglu and Behrman scale(1 week)

研究者

发起方
University Hospital, Gasthuisberg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jasper Verguts

MD, PhD

University Hospital, Gasthuisberg

研究点 (2)

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