Laparoscopic Surgery, Pneumoperitoneum
Conditions
Keywords
Laparoscopic surgery, Pneumoperitoneum, Peritoneal perfusion, Intra-abdominal pressure
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.
Interventions
OTHERIntra-abdominal pressure during laparoscopy
Insufflation pressure of the abdomen during laparoscopy
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands
Outcome results
None listed