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出境医 / 临床实验 / The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery (PERFUSION)

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

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

Study Design
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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
Arms and Interventions
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
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
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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.
Contacts and Locations

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
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 26, 2019
Last Update Posted Date May 8, 2020
Actual Study Start Date  ICMJE June 13, 2018
Actual Primary Completion Date December 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery
Official Title  ICMJE The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery: a Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Laparoscopic Surgery
  • Pneumoperitoneum
Intervention  ICMJE Other: Intra-abdominal pressure during laparoscopy
Insufflation pressure of the abdomen during laparoscopy
Study Arms  ICMJE
  • Experimental: Intra-abdominal pressure of 8 mmHg
    The laparoscopy insufflator is set to a pressure of 8 mmHg
    Intervention: Other: Intra-abdominal pressure during laparoscopy
  • Experimental: Intra-abdominal pressure of 12 mmHg
    The laparoscopy insufflator is set to a pressure of 12 mmHg
    Intervention: Other: Intra-abdominal pressure during laparoscopy
  • Experimental: Intra-abdominal pressure of 16 mmHg
    The laparoscopy insufflator is set to a pressure of 16 mmHg
    Intervention: Other: Intra-abdominal pressure during laparoscopy
Publications * Albers KI, Polat F, Loonen T, Graat LJ, Mulier JP, Snoeck MM, Panhuizen IF, Vermulst AA, Scheffer GJ, Warlé 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2019) 		30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 24, 2018
Actual Primary Completion Date December 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03928171
Other Study ID Numbers  ICMJE 2018-4313
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michiel C Warlé, MD, PhD Radboud University
PRS Account Radboud University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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