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Completed

NCT Number: NCT03928171

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

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.

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Key information

Conditions

Laparoscopic Surgery Digestive System Diseases Peritoneal Diseases Pneumoperitoneum

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canisius Wilhelmina Hospital

Nijmegen, Gelderland, 6532SZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intra-abdominal pressure during laparoscopy

Other

Insufflation pressure of the abdomen during laparoscopy

Primary outcomes

  1. Peritoneal perfusion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery: a Pilot Study

Acronym: PERFUSION

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2019
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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