A total of 850 patients were enrolled and randomized. After the exclusion of 11 patients, 839 were subject to the modified intention-to-treat population (422 in the ICG+ group and 417 in the ICG− group). The rate of anastomotic leakage (grade A+B+C) was significantly lower in the ICG+ group (7.6%) than in the ICG− group (11.8%). The rate of anastomotic leakage (grade B+C) was 4.7% in the ICG+ group and 8.2% in the ICG− group (P=0.044)
In rectal surgery, anastomotic leakage is one of the most critical complications, occurring in 11% to 15% of patients, 3–6 and it significantly worsens the short-term outcome by increasing the rate of reoperation and duration of hospitalization. Furthermore, long-term outcomes, such as the rate of local recurrence and concurrent cancer-specific survival, are also affected.
The present RCT evaluated the superiority of ICG-FI in reducing the rate of anastomotic leakage in minimally invasive rectal cancer surgery.
https://pubmed.ncbi.nlm.nih.gov/37218517/
