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

Area of Science:

• Surgical innovation
• Biomedical engineering
• Medical device testing

Background:

• Anastomotic leak is a significant postoperative concern in circular stapler surgery.
• Variability in testing methods hinders the assessment and comparison of new surgical stapling technologies.
• Robust preclinical test methods are essential for advancing stapling device technology.

Purpose of the Study:

• To develop and validate novel, reproducible preclinical test methods for evaluating surgical staplers.
• To compare the performance of triple-row (TriEEA) and double-row (ECP) circular staplers using these new methods.

Main Methods:

• Quantified leak pressure, staple line perfusion, staple line security, and device removal force.
• In vivo testing for leak and perfusion; synthetic medium testing with Instron for removal force and security.
• Statistical analysis using unpaired student's t-test or Kruskal-Wallis test (P < .05).

Main Results:

• Triple-row staplers (TriEEA) exhibited 73% higher leak pressure than double-row staplers (ECP).
• TriEEA showed significantly higher staple line perfusion (148%) and required 78% less force for device removal.
• However, TriEEA staple line failure force was lower than ECP at specific pressures.

Conclusions:

• The study presents novel, reproducible methodologies for assessing surgical stapler performance.
• These methods enhance clinical relevance and facilitate direct comparisons between different stapling devices.
• The findings demonstrate the utility of the new test methods in evaluating key design features of triple-row versus double-row staplers.