Quantitative Indocyanine Green Fluorescence Angiography
OtherQuantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis
NCT Number: NCT05153954
Fluorescence angiography with indocyanine green (ICG-FA) has gained increased popularity in colorectal surgery to check perfusion to the newly-formed anastomotic area and decrease the rate of postoperative anastomotic leakage.
While qualitative ICG assessment has the advantage to be used instantly during the operative procedure, it does bear drawbacks (subjective assessment, dependent on factors like camera distance, ICG dose and white-light contamination).
The alternative is quantitative ICG assessment, which is performed by evaluating the time-intensity curve of the ICG-FA with an external analyzing software. The procedure is showing promising results, but the methodology is still reported very heterogeneously.
This study is a multi-center, prospective, standardized, surgeon-blinded observational trial. The key aspect of this study is the non-interventional design with blinding of both the qualitative and quantitative results from the ICG perfusion measurement, providing no chance of influencing the course of the operation. Assessment of perfusion will be performed postoperatively blinded to the outcome. Assessment of the pre-anastomotic area is intraoperatively performed by an image analysis software that then calculates a perfusion score based on an algorithm integrating relevant perfusion metrics. The primary outcome is the combined rate of early and late anastomotic complications within 90 days postoperatively.
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Notify Me18 year and older
All sexes
Observational
Department of Surgery, Zealand University Hospital, Køge, Region Sjælland, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Quantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis
Time frame: 3 months
combined rate of all anastomotic complications
Time frame: 90 days
Time frame: 90 days
Time frame: 10 days
Time frame: 90 days
obstipation and intolerance of oral intake due to nonmechanical factors that disrupt the normal coordinated propulsive motor activity of the gastrointestinal tract following abdominal surgery
Time frame: 1 month
surgical complication in which a wound ruptures along a surgical incision
Time frame: 90 days
Time frame: 1 day
Time frame: 1 month
Time frame: 1 month
Number of patients had have to be readmitted to the hospital due to postoperative complications
Time frame: 1 month
Time frame: 2 days
Continuous ECG-monitoring intraoperatively and postoperatively
Zealand University Hospital
Other
Quantitative ICG Fluorescence Angiography in Colorectal Surgery (QUANTICO): a Protocol for a Prospective, Standardized, Observational, Surgeon-blinded Multi-center Trial
Acronym: QUANTICO
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