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

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ClinicalTrials.gov Identifier: NCT03928171
Recruitment Status : Completed
First Posted : April 26, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment Phase
Laparoscopic Surgery Pneumoperitoneum Other: Intra-abdominal pressure during laparoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery: a Pilot Study
Actual Study Start Date : June 13, 2018
Actual Primary Completion Date : December 24, 2018
Actual Study Completion Date : December 24, 2018

Arm Intervention/treatment
Experimental: Intra-abdominal pressure of 8 mmHg
The laparoscopy insufflator is set to a pressure of 8 mmHg
Other: Intra-abdominal pressure during laparoscopy
Insufflation pressure of the abdomen during laparoscopy

Experimental: Intra-abdominal pressure of 12 mmHg
The laparoscopy insufflator is set to a pressure of 12 mmHg
Other: Intra-abdominal pressure during laparoscopy
Insufflation pressure of the abdomen during laparoscopy

Experimental: Intra-abdominal pressure of 16 mmHg
The laparoscopy insufflator is set to a pressure of 16 mmHg
Other: Intra-abdominal pressure during laparoscopy
Insufflation pressure of the abdomen during laparoscopy




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928171


Locations
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Netherlands
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands, 6532SZ
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Michiel C Warlé, MD, PhD Radboud University

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03928171     History of Changes
Other Study ID Numbers: 2018-4313
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Radboud University:
Laparoscopic surgery
Pneumoperitoneum
Peritoneal perfusion
Intra-abdominal pressure

Additional relevant MeSH terms:
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Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases