Quantitative ICG Fluorescence Angiography in Colorectal Surgery
- Conditions
- Colorectal CancerAnastomotic Leak
- Interventions
- Other: Quantitative Indocyanine Green Fluorescence Angiography
- Registration Number
- NCT05153954
- Lead Sponsor
- Zealand University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- Age 18 years or older
- Capable of giving informed consent
- ASA Classification: status I-III
- Planned for PME or TME with minimally invasive approach and primary anastomosis
- Strong suspicion of or biopsy-verified sigmoid or rectal cancer Stage I-IV cancer
- Known allergy to ICG or iodine
- Emergency procedure
- Pregnancy or if the patient is currently nursing
- Surgeons decide to do unblinded quantitative or qualitative ICG-FA
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Colorectal cancer patients Quantitative Indocyanine Green Fluorescence Angiography Patients who can be treated with either PME or TME and receive a primary anastomosis during surgery.
- Primary Outcome Measures
Name Time Method Postoperative anastomotic complications 3 months combined rate of all anastomotic complications
- Secondary Outcome Measures
Name Time Method Number of participants with complications according to Clavien-Dindo Classification 90 days Number of participants with postoperative paralytic ileus 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
Length of hospital stay 1 month Duration of surgery 1 day Hospital readmission 1 month Number of patients had have to be readmitted to the hospital due to postoperative complications
Number of participants with anastomotic leakage rate, severity (grade A-C) 90 days Number of participants with wound dehiscence 1 month surgical complication in which a wound ruptures along a surgical incision
Number of participants with postoperative bleeding 10 days Comprehensive complications index 90 days Reoperation rate 1 month QT interval variability 2 days Continuous ECG-monitoring intraoperatively and postoperatively
Trial Locations
- Locations (2)
Department of Surgery, Zealand University Hospital
🇩🇰Køge, Region Zealand, Denmark
Department of Surgery, Herlev Hospital
🇩🇰Herlev, Denmark