Evaluation of Adding Small Amounts of Oxygen to the CO2 Pneumoperitoneum Upon Pain and Inflammation
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.,.).
- 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
- 是
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
Jasper Verguts
MD, PhD
University Hospital, Gasthuisberg
