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

Not Applicable

Completed

• Conditions: Pneumoperitoneum; Laparoscopic Surgery
• Interventions: Other: Intra-abdominal pressure during laparoscopy

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-06-13
• Primary Completion: 2018-12-24
• Study Completion: 2018-12-24
• Status Verified: 2019-04
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-26
• Last Update Submitted: 2020-05-07
• Last Update Posted: 2020-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Adults (≥ 18 years old)
• Scheduled for robot-assisted colorectal laparoscopic surgery

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-abdominal pressure of 8 mmHg	Intra-abdominal pressure during laparoscopy	The laparoscopy insufflator is set to a pressure of 8 mmHg
Intra-abdominal pressure of 12 mmHg	Intra-abdominal pressure during laparoscopy	The laparoscopy insufflator is set to a pressure of 12 mmHg
Intra-abdominal pressure of 16 mmHg	Intra-abdominal pressure during laparoscopy	The laparoscopy insufflator is set to a pressure of 16 mmHg

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.

Trial Locations

Locations (1)

Canisius Wilhelmina Hospital; 🇳🇱 Nijmegen, Gelderland, Netherlands