Reproducible, Repeatable and Clinically-relevant Hemostasis Scoring

Background: Although the assessment of hemostasis is frequently performed during stapling procedures, and is necessary during product development, there is currently no widely-accepted scoring system for its evaluation. In order to better measure stapler performance, we developed a 5-point Likert-type scale to evaluate intra-operative bleeding in stapling applications.

Methods: The scale was evaluated internally by novice and experienced appraisers, and then used by 154 surgeons that viewed video segments of stapling in pig that displayed varying levels of hemostasis.

Results: Reproducibility and repeatability of the scale among internal appraisers, as well as the surgeons, was excellent with Kendall’s W of 0.94-0.98 (repeatability) and 0.93-0.95 (reproducibility) internally and 0.85 and 0.95, respectively for surgeons. More than 90% of surgeons felt the hemostasis scale was clinically relevant for evaluating hemostasis during stapling.

Conclusions: The scale should be a useful tool in assessing hemostasis with high confidence in its repeatability and reproducibility.