About this trial
A serious and life-threatening complication to rectal surgery is anastomotic leakage, AL. In Denmark, approximately 800 patients every year, are operated for rectal cancer, 50% of these with resection and anastomosis.
The registered leakage rate for rectal anastomosis is 10-15%. AL can be life threatening and has long-term adverse effects for the patients, with reduced quality of life, due to a poor functional result of the neo-rectum known as low anterior rectal syndrome (LARS). Fistulas to the vagina or urinary tract are other severe complications. Furthermore, AL is associated with an increased risk of reccurence1. Finally, the AL-associated morbidity is also a significant economic burden to the health care system due to prolonged hospital stay, medicine, and reoperations.
During surgery it is important to ensure optimal healing conditions for the anastomosis. The blood flow is evaluated by colour and pulsation in the mesentery.
Studies suggest that it might be easier to evaluate the perfusion using fluorescent dye. This evaluation is a subjective evaluation, based mostly on the surgeon's experience.
Assessing fluorescence by computer-based software, qICG, has been developed. But cut-off values for sufficient blood flow to diminish the risk of leakage, has not yet been defined.
Aim:
Primary objective: To establish cut-off values of qICG, where blood flow assumes sufficient for healing, and thereby reduce the risk of leakage.
Secondary objective: To identify which long-term complications grade A, B and C leakages entails on Quality of Life.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients, older than 18, undergoing laparoscopic or robotic surgery for rectal cancer, with or without combination with trans-anal approach.
Disqualifiers
Allergy of iodide. Terminal renal disease. Pregnancy. Lactation. Previous left side colon resection or major surgery on intraabdominal vessels.
Trial population
Adults with rectal cancer undergoing surgery low anterior resection with anastomosis
Trial design
Cohort
Prospective
Treatments tested in this trial
qICG
Diagnostic testEvaluation of bowel fluorescence by pixel software, qICG
Treatment groups
Trial outcomes
Primary outcomes
Cut off Values for fluorescence
ROC curves
Secondary outcomes
Perfusion assessed quantitatively
Compared in leak and no-leak group by using wilcoxon ranksum test
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: