Clearance Rate of Peritoneal Fluid Assessed by Post-operative Ultrasound Decreases After Full Conditioning Pneumoperitoneum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- clearance rate of peritoneal fluid
研究概览
简要总结
Measurement of residual peritoneal fluid after laparoscopic surgery
详细描述
Primary endpoints
- to evaluate whether the clearance rate of peritoneal fluid is exponential or linear over time. (absorption rate expected for Adept ~30-60 ml/h)
- to evaluate the role of the mesothelial barrier in this clearance rate.
Knowing that diffusion to and from peritoneal fluid decreases with increasing molecular weight (MW), our hypothesis is that clearance rate will decrease following peritoneal conditioning. Indeed a decreased mesothelial trauma (either through hypoxia or through denudation) and retraction will expose less the basal membrane
Secondary endpoints:
-To confirm the decrease in post-operative pain as measured by VAS-score and inflammation as measured by CRP and leucocytosis with the full conditioning of the pneumoperitoneum.
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
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women planned to undergo a total or subtotal laparoscopic hysterectomy and having signed the informed consent.
- •No limitation in body mass index or uterine size is made.
排除标准
- •pregnancy
- •immunodeficiency
- •refuse or unable to sign informed consent
- •chronic disease (i.e. COPD, Crohn, cardiac...)
- •known allergy for Adept©
研究组 & 干预措施
Adept
1000ml Adept will be left in the abdomen and measured over time
干预措施: Carbon dioxide (Procedure)
Adept
1000ml Adept will be left in the abdomen and measured over time
干预措施: full conditioning (Procedure)
Adept
1000ml Adept will be left in the abdomen and measured over time
干预措施: Adept (Drug)
Ringer-lactate
1000 ml of Ringer lactate left in the abdomen and measured over time
干预措施: Carbon dioxide (Procedure)
Ringer-lactate
1000 ml of Ringer lactate left in the abdomen and measured over time
干预措施: full conditioning (Procedure)
Ringer-lactate
1000 ml of Ringer lactate left in the abdomen and measured over time
干预措施: Ringer Lactate (Drug)
结局指标
主要结局
clearance rate of peritoneal fluid
时间窗: 3 days after surgery
We will estimate the residual volume of fluid in the abdominal cavity in a 30° anti-Trendelenburg position after 1 minute in this position. Measurements will be repeated daily until discharge.
次要结局
- Pain and inflammation score(3 days after surgery)
研究者
Jasper Verguts
MD, PhD
University Hospital, Gasthuisberg