A single center randomized trial was undertaken between 2018 and 2019. Those patients who underwent a stapled colorectal anastomosis were randomized 1:1 for ICG FA vs. visual clinical assessment of blood perfusion of the anastomosed colon and rectal stump (non‐ICG FA group). The primary end‐point was to assess whether ICG FA was associated with a reduction in the incidence of AL . Secondary outcomes were rate of postoperative complications and change in the level of bowel resection.
A total of 380 patients undergoing sigmoid and rectal resection were enrolled. After randomization, three patients were excluded. The results of 377 cases were available for analysis; 187 had ICG FA and 190 were in non‐ICG FA group. ICG FA identified an impaired blood perfusion of colon in 36 (19%) cases. An AL (Grade A, B and C) developed in 48 patients: 17 (9.1%) in ICG FA group vs. 31 (16.3%) in non‐ICG FA group (p = 0.04). ICG FA did not decrease AL rate of high (at 9 –15 cm from anal verge) anastomoses: 1.3% vs 4.6% in non‐ICG FA group (p=0.37). In contrast, a decrease in AL rate was found for low (4 – 8 cm) colorectal anastomoses (14.4% in ICG FA vs. 25.7% non‐ICG FA in non‐ICG FA group (p=0.04)
ICG FA is associated with a reduction in anastomotic leakage following low anterior resection..