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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03928171

Recruitment Status Completed

First Posted April 26, 2019

Last update posted May 8, 2020

Study Description

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:Pneumoperitoneum
    Laparoscopic Surgery
  • Intervention/Treatment: Other: Intra-abdominal pressure during laparoscopy
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2018
  • Actual Primary Completion Date: December 2018
  • Actual Study Completion Date: December 2018
Arms and interventions
Arm Intervention/treatment
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
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
Outcome Measures
  • 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.
Eligibility Criteria
  • 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 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.

Contacts and Locations
Contacts
Locations

Netherlands, Gelderland
Canisius Wilhelmina Hospital
Nijmegen

Sponsors and Collaborators

Radboud University

Investigators

Principal Investigator: Michiel C Warlé, MD, PhD Radboud University

More Information
  • 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 8, 2020
  • Last Verified: April 2019
  • 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: Pneumoperitoneum