A Single-blind, Randomized Study to Compare Impacts of Intraperitoneal Pressure (8mmHg Versus 12 mmHg) and CO2 Gas (Cool, Dry CO2 Gas Versus Warmed; Humidified Co2 Gas) on Surgical Peritoneal Environment During Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Expression of genes encoding components of the fibrinolytic system, extracellular matrix and adhesion molecules, and inflammatory cytokine signalling molecules in peritoneal tissues
研究概览
简要总结
Use lay language.
The primary purpose is to compare the impacts of intraperitoneal pressure (8mmHg versus 12 mmHg) and CO2 gas (cool, dry CO2 gas versus warmed, humidified CO2 gas) on gene expression in peritoneal tissues during laparoscopic surgery. We hypothesize that combined use of a low Intraperitoneal pressure (8mmHg) and warmed, humidified CO2 gas during CO2 pneumoperitoneum may be better in minimizing adverse effects on surgical peritoneal environment and improving clinical outcomes compared to the standard intraperitoneal pressure (12mmHg) and standard cool, dry CO2 gas.
详细描述
Patients undergoing laparoscopic hysterectomy with promontofixation are randomized into four groups: Group 1: 12mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20), Group 2: 12mmHg intraperitoneal pressure with warmed, humidified CO2 gas (n=20), Group 3: 8mmHg intraperitoneal pressure with cool, dry CO2 gas (n=20), Group 4: 8mmHg intraperitoneal pressure with warmed, humidified CO2 gas (n=20).
Normal peritoneum is collected from the parietal wall at the beginning of laparoscopic surgery and at 1 and 2 hours. Expression of genes encoding components of the fibrinolytic system, extracellular matrix and adhesion molecules, and inflammatory cytokine signaling molecules in peritoneal tissues are measured by real-time PCR.
Quality of post-operative recovery by QoR-40, post-operative pain by Visual Analog Scale, per or post operative complications and intraoperative core temperature are assessed and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 45-75 years old
- •Petients undergoing laparoscopic hysterectomy with promontofixation for uterine prolapse
- •Menopaused
- •ASA class I or II
排除标准
- •Absolute contraindications to laparoscopy
- •Previous history of pelvic surgery, endometriosis and/or infection
- •Pathological peritoneal tissue
- •BMI more than 30
- •Height less than 150cm
结局指标
主要结局
Expression of genes encoding components of the fibrinolytic system, extracellular matrix and adhesion molecules, and inflammatory cytokine signalling molecules in peritoneal tissues
时间窗: at1 hour and 2 hours (day 1)
次要结局
- Post-operative pain(at day 1)
- Intraoperative core temperature(at day 1)
- Quality of post-operative recovery(at day 1)
- Per or post operative complications(at day 1)