The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery (PERFUSION)

Radboud University Medical Center

Status: Completed

Conditions: Laparoscopic Surgery; Pneumoperitoneum

Treatments: Other: Intra-abdominal pressure during laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03928171

2018-4313

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

Intra-abdominal pressure of 8 mmHg

Experimental group

Description:

The laparoscopy insufflator is set to a pressure of 8 mmHg

Treatment:

Other: Intra-abdominal pressure during laparoscopy

Intra-abdominal pressure of 12 mmHg

Experimental group

Description:

The laparoscopy insufflator is set to a pressure of 12 mmHg

Treatment:

Other: Intra-abdominal pressure during laparoscopy

Intra-abdominal pressure of 16 mmHg

Experimental group

Description:

The laparoscopy insufflator is set to a pressure of 16 mmHg

Treatment:

Other: Intra-abdominal pressure during laparoscopy