Objective: Observational studies have shown that fluorescence angiography (FA) decreases the incidence of anastomotic leak (AL) in colorectal surgery, but high-quality pooled evidence was lacking. Therefore, we aimed at confirming this preliminary finding using a systematic review and meta-analysis of randomised controlled trials (RCTs) in the field.

Methods: MEDLINE, Embase and CENTRAL were searched for RCTs assessing the effect of intra-operative FA versus standard assessment of bowel perfusion on the incidence of AL of colorectal anastomosis. The systematic review complied with the PRISMA 2020 and AMSTAR2 recommendations and was registered in PROSPERO. Pooled relative risk (RR) and pooled risk difference (RD) were obtained using models with random effects. Heterogeneity was assessed using the Q-test and quantified using the I² value. Certainty of evidence was assessed using the GRADE Pro tool.

Results: One hundred and eleven articles were screened, 108 were excluded and three were kept for inclusion. The three included RCTs compared assessment of the perfusion of the bowel during creation of a colorectal anastomosis using FA versus standard practice. In meta-analysis, FA was significantly protective against AL (3 RCTs, 964 patients, RR: 0.67, 95% CI: 0.46 to 0.99, I²: 0%, p = 0.04). The RD of AL was non-significantly decreased by 4 percentage points (95%CI: - 0.08 to 0, I²: 8%, p = 0.06) when using FA. Certainty of evidence was considered as moderate.

Conclusion: The effect of FA on prevention of AL in colorectal surgery exists but is potentially of small magnitude. Considering the potential magnitude of effect of FA, we advise that future RCTs have an adequate sample size, include a cost-benefit analysis of the technique and better define the subpopulation who could benefit from FA.