The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery
PERFUSION
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 24, 2018
CompletedFirst Submitted
Initial submission to the registry
April 23, 2019
CompletedFirst Posted
Study publicly available on registry
April 26, 2019
CompletedMay 8, 2020
April 1, 2019
6 months
April 23, 2019
May 7, 2020
Conditions
Keywords
Outcome Measures
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.
3 minutes after intravenous injection of indocyanine green
Study Arms (3)
Intra-abdominal pressure of 8 mmHg
EXPERIMENTALThe laparoscopy insufflator is set to a pressure of 8 mmHg
Intra-abdominal pressure of 12 mmHg
EXPERIMENTALThe laparoscopy insufflator is set to a pressure of 12 mmHg
Intra-abdominal pressure of 16 mmHg
EXPERIMENTALThe laparoscopy insufflator is set to a pressure of 16 mmHg
Interventions
Insufflation pressure of the abdomen during laparoscopy
Eligibility Criteria
You may qualify if:
- Adults (≥ 18 years old)
- Scheduled for robot-assisted colorectal laparoscopic surgery
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, 6532SZ, Netherlands
Related Publications (1)
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.
PMID: 32194255DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michiel C Warlé, MD, PhD
Radboud University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2019
First Posted
April 26, 2019
Study Start
June 13, 2018
Primary Completion
December 24, 2018
Study Completion
December 24, 2018
Last Updated
May 8, 2020
Record last verified: 2019-04