The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery
Not Applicable
Completed
- Conditions
- PneumoperitoneumLaparoscopic Surgery
- Registration Number
- NCT03928171
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Adults (≥ 18 years old)
- Scheduled for robot-assisted colorectal laparoscopic surgery
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Peritoneal perfusion 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Canisius Wilhelmina Hospital
🇳🇱Nijmegen, Gelderland, Netherlands
Canisius Wilhelmina Hospital🇳🇱Nijmegen, Gelderland, Netherlands