Abstract
BACKGROUND: Robot-assisted surgery (RAS) is increasingly being used, yet its cost-effectiveness remains debated. Cost analyses of RAS are therefore essential but remain challenging. This systematic review evaluated the quality of cost analyses in randomized clinical trials (RCTs) comparing RAS with alternative surgical approaches. METHODS: A systematic review was performed in PubMed, EMBASE, Cochrane Library, and Web of Science from inception up to August 2025. RCTs were included if they compared RAS with other approaches and conducted a cost analysis. Risk of bias was assessed using the revised Cochrane Risk-of-Bias tool. The methodological quality and comprehensiveness of cost analyses were evaluated with the Economic Evaluation Bias Assessment Tool (ECOBIAS) and Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist, respectively. Studies were evaluated for key structural and component-specific costs of RAS. RESULTS: Overall, 38 RCTs involving 5832 patients were included. Most studies focused on general surgical procedures (20 RCTs, 53%), followed by urology (7), gynaecology (7), and cardiothoracic surgery (4). RAS was compared with laparoscopic surgery in 23 RCTs, open surgery in 14 RCTs, and another robotic modality in one RCT. Regarding bias, 10 RCTs (26%) were considered high risk, and 24 (63%) had some concerns. On average, RCTs met 5 of 11 ECOBIAS criteria and 14 of 28 CHEERS items. Only 15 of 38 RCTs (39%) included key structural costs of RAS, such as robot acquisition and maintenance, whereas 12 of 38 RCTs (32%) provided a component-specific cost overview. RAS was more expensive in 33 of 36 RCTs (92%). CONCLUSION: Randomized trials comparing RAS with other surgical approaches rarely perform adequate cost assessments and cost-effectiveness analyses. The substantial risk of bias, methodological heterogeneity, and partial cost reporting observed underline the need for uniform economic evaluation in RCTs on RAS. Registration number: CRD42024520677 (https://www.crd.york.ac.uk/prospero/).