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

Primary Purpose

Laparoscopic Surgery, Pneumoperitoneum

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Intra-abdominal pressure during laparoscopy
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Surgery focused on measuring Laparoscopic surgery, Pneumoperitoneum, Peritoneal perfusion, Intra-abdominal pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Canisius Wilhelmina Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Intra-abdominal pressure of 8 mmHg

Intra-abdominal pressure of 12 mmHg

Intra-abdominal pressure of 16 mmHg

Arm Description

The laparoscopy insufflator is set to a pressure of 8 mmHg

The laparoscopy insufflator is set to a pressure of 12 mmHg

The laparoscopy insufflator is set to a pressure of 16 mmHg

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2019
Last Updated
May 7, 2020
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03928171
Brief Title
The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery
Acronym
PERFUSION
Official Title
The Effect of Intra-abdominal Pressure on Peritoneal Perfusion During Laparoscopic Colorectal Surgery: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 13, 2018 (Actual)
Primary Completion Date
December 24, 2018 (Actual)
Study Completion Date
December 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Surgery, Pneumoperitoneum
Keywords
Laparoscopic surgery, Pneumoperitoneum, Peritoneal perfusion, Intra-abdominal pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intra-abdominal pressure of 8 mmHg
Arm Type
Experimental
Arm Description
The laparoscopy insufflator is set to a pressure of 8 mmHg
Arm Title
Intra-abdominal pressure of 12 mmHg
Arm Type
Experimental
Arm Description
The laparoscopy insufflator is set to a pressure of 12 mmHg
Arm Title
Intra-abdominal pressure of 16 mmHg
Arm Type
Experimental
Arm Description
The laparoscopy insufflator is set to a pressure of 16 mmHg
Intervention Type
Other
Intervention Name(s)
Intra-abdominal pressure during laparoscopy
Intervention Description
Insufflation pressure of the abdomen during laparoscopy
Primary Outcome Measure Information:
Title
Peritoneal perfusion
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michiel C Warlé, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canisius Wilhelmina Hospital
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6532SZ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
32194255
Citation
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.
Results Reference
derived

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

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