Evaluating Performance of Circular Staplers Using Comparative Test Methods for Evidence-Based Surgery

Abstract

Background Circular stapler anastomosis is a common surgical procedure. Despite technological advancements, anastomotic leak remains a postoperative concern. Assessment of new technologies is impeded by variations in test methods and analysis, precluding outcome reproducibility and direct comparisons of results across studies. The development of robust and reproducible preclinical test methods is critical to accelerating stapling technology advancements. Methodology Leak pressure, staple line perfusion and security, and device removal force were quantified for triple-row (Tri-staple EEA, TriEEA) and double-row staplers (Echelon Circular Powered, ECP). Leak and perfusion testing were performed in vivo. Device removal force and staple line security testing were performed with synthetic medium using an Instron. Data were analyzed using unpaired student’s t-test or Kruskal-Wallis test, with statistical significance defined as P < .05. Results Leak pressure was 73% higher in TriEEA vs ECP ( P = .016). TriEEA staple line failure force was lower than ECP at 40 and 50 mmHg ( P = .001 and P = .023, respectively). Perfusion to the staple line was higher (148%) for TriEEA than for ECP ( P = .003) and the force required to remove the device from its stapled anastomosis was 78% lower for TriEEA than for ECP ( P < .001). Discussion/Conclusions This report addresses a primary limitation in stapling research by presenting novel methodologies which enhance clinical relevance and provide sufficient detail for reproduction by independent investigators. These methods are applied to a comparison between triple-row and double-row staplers to demonstrate utility of new test methods in assessing key technology design features.