CClinicalTrials.gg
Sign In
CompletedNCT03928171PERFUSIONUpdated May 8, 2020

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

An interventional study of Intra-abdominal pressure during laparoscopy in Laparoscopic Surgery and Pneumoperitoneum, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-08.

Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jun 2018, registered Apr 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Laparoscopic Surgery
  • Pneumoperitoneum

Browse trials for

Keywords

  • Laparoscopic surgery
  • Pneumoperitoneum
  • Peritoneal perfusion
  • Intra-abdominal pressure
03

In context

Pneumoperitoneum

149 studies on the registry are indexed under Pneumoperitoneum; 29 are open to participants now.

This study's enrollment of 30 is below the median of 79 across 96 interventional studies indexed under Pneumoperitoneum.

Browse Pneumoperitoneum studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Intra-abdominal pressure of 8 mmHg

    The laparoscopy insufflator is set to a pressure of 8 mmHg

    Other: Intra-abdominal pressure 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

  • Experimental
    Intra-abdominal pressure of 16 mmHg

    The laparoscopy insufflator is set to a pressure of 16 mmHg

    Other: Intra-abdominal pressure during laparoscopy

Interventions

  • OtherIntra-abdominal pressure during laparoscopy

    Insufflation pressure of the abdomen during laparoscopy

06

What researchers measure

Primary outcomes

  1. Peritoneal perfusion

    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.

    Time frame: 3 minutes after intravenous injection of indocyanine green

07

Study locations

1 site
  • Canisius Wilhelmina Hospital
    Nijmegen, Gelderland 6532SZ, Netherlands
08

References and documents

Publications

  • Albers KI, Polat F, Loonen T, Graat LJ, Mulier JP, Snoeck MM, Panhuizen IF, Vermulst AA, Scheffer GJ, Warle MC. Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study. Int J Surg. 2020 May;77:8-13. doi: 10.1016/j.ijsu.2020.03.019. Epub 2020 Mar 17. PubMed 32194255 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03928171
Lead sponsor
Radboud University Medical Center
Responsible party
Sponsor
First posted
Apr 26, 2019
Start date
Jun 13, 2018
Primary completion
Dec 24, 2018
Completion
Dec 24, 2018
Last update
May 8, 2020

Study contacts

Michiel C Warlé, MD, PhD
principal investigator · Radboud University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pneumoperitoneum→

Other studies from this sponsor

Radboud University Medical Center

Start the discussion