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.
Study Type
OBSERVATIONAL
Enrollment
114
Quantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis
Department of Surgery, Zealand University Hospital
Køge, Region Sjælland, Denmark
Department of Surgery, Herlev Hospital
Herlev, Denmark
Postoperative anastomotic complications
combined rate of all anastomotic complications
Time frame: 3 months
Number of participants with complications according to Clavien-Dindo Classification
Time frame: 90 days
Number of participants with anastomotic leakage rate, severity (grade A-C)
Time frame: 90 days
Number of participants with postoperative bleeding
Time frame: 10 days
Number of participants with postoperative paralytic ileus
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: 90 days
Number of participants with wound dehiscence
surgical complication in which a wound ruptures along a surgical incision
Time frame: 1 month
Comprehensive complications index
Time frame: 90 days
Duration of surgery
Time frame: 1 day
Reoperation rate
Time frame: 1 month
Hospital readmission
Number of patients had have to be readmitted to the hospital due to postoperative complications
Time frame: 1 month
Length of hospital stay
Time frame: 1 month
QT interval variability
Continuous ECG-monitoring intraoperatively and postoperatively
Time frame: 2 days
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