The Study, which took place across multiple centres in the Netherlands, showed statistically significant benefits using ICG for left sided colectomies. Summary of key findings are as follows:
- This prospective, phase III, national multicentre randomised controlled trial included patients scheduled for laparoscopic or robotic colorectal surgery for benign and malignant diseases from eight participating hospitals in the Netherlands.
- A total of 931 patients were included between 2 July 2020 and 21 February 2023 (FGBA71 group n=463; CBA-group n=468). The study population comprised 485 (52·1%) men and 446 (47·9%) women.
- While the overall 90-day AL rate was not significantly different between the ICG group and non-ICG group (as noted in the abstract summary), the sub-group analysis of left sided colectomies did exhibit marked differences and showed a significant reduction in leak rates when ICG was applied.
- Left Sided Colectomy had superior results for patients when ICG was used:
- Indocyanine Green (ICG) use demonstrated significant improvement in leak rates for left sided colectomy
- This Phase III trial of 900+ patients showed a 5.2% reduction in anastomotic leak rates when ICG was used for left sided colectomy
- A leak rate of 12.8% was present in non-ICG group v’s 7.6% when ICG was used in left sided colectomy group
Overall the study unequivocally shows a statistically significant reduction in anastomotic leak rates when ICG is used for left sided colectomy procedures.
