Assessment of Bowel Perfusion Using Indocyanine Green Fluorescence Imaging during Laparoscopic Resection of Colorectal Cancer: A Randomized Controlled Trial

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Abstract

Background Morbidity and death are linked to anastomotic leaking after colorectal cancer resection. Indocyanine green-fluorescence angiography has shown promising outcomes in lowering the rate of AL and properly assessing the adequacy of the anastomosis. Aim To evaluate whether intraoperative indocyanine green fluorescence angiography (ICG‑FA) reduces the rate of clinically significant anastomotic leak after laparoscopic colorectal cancer resection and to describe its impact on intraoperative decision‑making. Methods Parallel‑group randomized controlled trial (1:1 ICG‑FA vs standard visual assessment). The primary outcome was anastomotic leak within 30 days. Secondary outcomes were change in transection line, operative time, postoperative complications, reoperation, and length of stay. Categorical outcomes were analyzed with Fisher’s exact test and continuous outcomes with non‑parametric or t‑tests as appropriate; effects are presented with 95% confidence intervals (CI). Results Forty‑three patients were randomized (ICG‑FA n = 22, Control n = 21). Anastomotic leak occurred in 0/22 vs 2/21; risk difference − 9.5 percentage points (95% CI -28.9 to 12.2); Fisher’s exact p = 0.23. ICG‑FA prompted a change in transection line in 5/22 (22.7%) vs 2/21 (9.5%; p = 0.20). Mean operative time was 205.9 ± 27.2 vs 221.5 ± 27.6 minutes (p = 0.03). Pulmonary complications occurred more often in the ICG‑FA group (5/22 [22.7%] vs 0/21 [0%]; p = 0.02). No ICG‑related adverse events were observed. Conclusion ICG‑FA was feasible and influenced intraoperative decision‑making; however, the reduction in anastomotic leak was not statistically significant in this small trial. Given baseline imbalances and limited power, findings should be interpreted cautiously and validated in larger, adequately powered studies. Trial Registration This trial was registered in the Pan African Clinical Trial Registry (PACTR) under the identifier PACTR202603814227601 on 24/03/2026 . The study was retrospectively registered becaus e there was no operational national clinical trials registry system during the enrollment period , and full efforts were made to register the trial at the earliest feasible opportunity.

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