Authors' objectives: This health technology assessment evaluates the effectiveness, cost-effectiveness, and budget impact of publicly funding indocyanine green fluorescence imaging to assess anastomotic perfusion in colorectal surgery. It also considers the experiences of patients undergoing colorectal cancer surgery.

Authors' results and conclusions: RESULTS We included 6 RCTs and 13 nonrandomized studies in the clinical evidence review. Compared with visual assessment alone, the addition of ICGFI to assess anastomotic perfusion during colorectal surgery reduced anastomotic leaks (GRADE: Low) and reoperations (GRADE: Low) and slightly reduced sepsis, but the evidence for the latter is very uncertain (GRADE: Very low to Low). ICGFI appeared to have little to no effect on hospital readmissions (GRADE: Low) or length of stay (GRADE: Low to Moderate), and its effect on mortality is very uncertain (GRADE: Very low). Our primary economic evaluation found that ICGFI is more effective and less costly than visual assessment alone and is highly likely to be cost-effective at the commonly used willingness-to-pay values of $50,000 and $100,000 per quality-adjusted life-year (QALY). The use of ICGFI could prevent 22 major anastomotic leaks per 1,000 patients undergoing colorectal surgery with anastomosis. With ICGFI, 45 patients would need to be treated to prevent an additional major anastomotic leak. Publicly funding ICGFI to assess anastomotic perfusion in colorectal surgery in Ontario would lead to an annual budget impact ranging from a cost savings of $0.81 million in year 1 to a cost savings of $8.13 million in year 5, for a total 5-year budget impact of $19.03 million in cost savings. We identified a previously published rapid review that found no qualitative literature on the patient experience of ICGFI. However, qualitative studies on the experience of patients who had undergone colorectal cancer surgery identified anastomotic leak and quality of life as key patient-important outcomes. In the included studies, patients often reported not receiving enough information about surgical outcomes and experiencing anxiety regarding cancer recurrence. We did not conduct direct patient engagement since the purpose of the technology is to enhance visualization of the surgical area and because it is expected that patients’ preferences and values would align with the potential for improved health outcomes from the use of ICGFI in colorectal surgery. CONCLUSIONS The evidence suggests that, compared with visual assessment alone, adding ICGFI to colorectal surgery can help reduce anastomotic leaks, reoperations, and sepsis but may not have an effect on hospital readmissions or length of stay. The effect of ICGFI on mortality is unclear. ICGFI is more effective and less costly than visual assessment alone. We estimate that publicly funding ICGFI for colorectal surgery in Ontario would result in cost savings of $19.03 million over the next 5 years. No literature was found on the patient experience of ICGFI. The qualitative literature on preferences and values for patients who had undergone colorectal cancer surgery identified anastomotic leak and quality of life as key outcomes, with study participants expressing concerns about surgical outcomes and cancer recurrence.

Authors' recommendations: Ontario Health, based on guidance from the Ontario Health Technology Advisory Committee, recommends publicly funding indocyanine green fluorescence imaging for perfusion assessment during colorectal surgery.

Authors' methods: We performed a systematic review of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane Risk-of-Bias Tool for randomized controlled trials (RCTs) and the Risk-of-Bias Assessment Tool for Nonrandomized Studies (RoBANS) for nonrandomized studies. We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-effectiveness analysis comparing ICGFI with visual assessment alone for the visualization of anastomotic perfusion during colorectal surgery from a public payer perspective. We also analyzed the budget impact of publicly funding ICGFI for colorectal surgery in Ontario. To contextualize the potential value of publicly funding ICGFI for colorectal surgery, we summarized a qualitative literature rapid review conducted by the Canadian Agency for Drugs and Technologies in Health (now Canada's Drug Agency).

Project Status: Completed

URL for project: https://ontariohealth.ca/system/health-innovation-pathway/reviews/hta-details?cf=indocyanine-green-fluorescence-imaging-colorectal-surgery

URL for protocol: https://www.crd.york.ac.uk/PROSPERO/view/CRD42024515923

Year Published: 2025

URL for published report: http://pmc.ncbi.nlm.nih.gov/articles/PMC12291517/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Pubmed ID: 40727261

Organisation Name: Ontario Health

Contact Address: 525 University Ave, Toronto, ON M5G 2L3

Contact Name: HealthInnovationPathway@ontariohealth.ca

Contact Email: HealthInnovationPathway@ontariohealth.ca

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