The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Peritoneal perfusion
研究概览
简要总结
Peritoneal perfusion during laparoscopic surgery is quantified by video recording after intravenous injection of indocyanine green at a pneumoperitoneum pressure of 8, 12 and 16 mmHg.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥ 18 years old)
- •Scheduled for robot-assisted colorectal laparoscopic surgery
排除标准
- •Severe liver- or renal disease
- •Pregnancy or lactation
- •Planned diagnostics or treatment with radioactive iodine < 1 week after surgery
- •BMI >35 kg/m2
- •Known or suspected hypersensitivity to indocyanine green, sodium iodide or iodine
- •Hyperthyroidism or thyroid adenomas
- •Use of medication interfering with ICG absorption as listed in the summary of product characteristics.
研究组 & 干预措施
Intra-abdominal pressure of 8 mmHg
The laparoscopy insufflator is set to a pressure of 8 mmHg
干预措施: Intra-abdominal pressure during laparoscopy (Other)
Intra-abdominal pressure of 12 mmHg
The laparoscopy insufflator is set to a pressure of 12 mmHg
干预措施: Intra-abdominal pressure during laparoscopy (Other)
Intra-abdominal pressure of 16 mmHg
The laparoscopy insufflator is set to a pressure of 16 mmHg
干预措施: Intra-abdominal pressure during laparoscopy (Other)
结局指标
主要结局
Peritoneal perfusion
时间窗: 3 minutes after intravenous injection of indocyanine green
Perfusion is quantified by video recording of the parietal peritoneum using the Firefly fluorescence module of the DaVinci surgical robot after intravenous injection of 0.2mg/kg indocyanine green. Fluorescent intensity in \[-\] over time is plotted in MATLAB, maximum fluorescent intensity and time to reach maximum fluorescent intensity are extracted.
次要结局
未报告次要终点