Cost analyses in randomized trials on robot-assisted surgery: systematic review.

Area of Science:

• Health Economics
• Surgical Innovation
• Clinical Trial Methodology

Background:

• Robot-assisted surgery (RAS) adoption is rising, but its cost-effectiveness is debated.
• Robust cost analyses are essential for evaluating RAS but present significant challenges.
• This systematic review assesses the quality of cost analyses within randomized clinical trials (RCTs) comparing RAS to alternative surgical methods.

Purpose of the Study:

• To systematically evaluate the methodological quality and comprehensiveness of cost analyses in RCTs comparing RAS with other surgical approaches.
• To identify common biases and reporting deficiencies in economic evaluations of RAS.
• To highlight the need for standardized economic assessment in RAS research.

Main Methods:

• A systematic literature search was conducted across PubMed, EMBASE, Cochrane Library, and Web of Science up to August 2025.
• Included RCTs compared RAS with alternative approaches and included a cost analysis.
• Risk of bias, methodological quality (ECOBIAS), and reporting comprehensiveness (CHEERS) were assessed for included studies.

Main Results:

• 38 RCTs involving 5832 patients were reviewed, primarily in general surgery, urology, and gynecology.
• A significant risk of bias was found in 26% of studies, with 63% having some concerns.
• On average, studies met only 5/11 ECOBIAS criteria and 14/28 CHEERS items, with incomplete reporting of structural and component-specific RAS costs. 92% of studies found RAS to be more expensive.

Conclusions:

• RCTs comparing RAS with alternative surgical approaches frequently lack adequate cost assessment and cost-effectiveness analysis.
• Substantial bias, methodological heterogeneity, and incomplete cost reporting necessitate uniform economic evaluation standards in RAS RCTs.
• Standardized economic evaluations are critical for accurate assessment of RAS value in clinical practice.