PURPOSES

To compare the risk of anastomotic leak (AL) between Ethicon manual circular staplers (two-row) versus Medtronic EEA circular stapler with Tri-Staple technology (three-row) and between Medtronic EEA circular stapler with DST Series technology (two-row) versus Tri-Staple technology.

METHODS

A retrospective cohort study was conducted in adult patients who underwent a left-sided colorectal surgery 2019-2022 in U.S. Premier Healthcare Database to assess the risk of AL within 30 days post-index procedure. The study devices were Ethicon manual circular staplers, Medtronic EEA circular stapler with DST technology, and Medtronic EEA circular stapler with Tri-Staple technology.

RESULTS

Across 447 hospitals, the cumulative incidences (95% confidence intervals [CI]) of AL within 30 days post-index procedure were 7.78% (6.91-8.74%) among 8337 patients in the Ethicon manual circular stapler cohort, 7.54% (6.87-8.27%) among 7928 patients in the Medtronic EEA circular stapler with DST technology cohort, and 8.19% (6.57-10.07%) among 1306 patients in the Medtronic EEA circular stapler with Tri-Staple technology cohort. Comparative analyses revealed no difference comparing Ethicon manual circular staplers with Medtronic EEA circular staplers with Tri-Staple technology (risk ratio [RR], 0.72; 95% CI, 0.52-1.01) or comparing Medtronic EEA circular staplers with DST technology to Tri-Staple technology (RR, 0.75; 95% CI, 0.53-1.06).

CONCLUSION

In this analysis of a large cohort of patients undergoing a left-sided colorectal surgery from a U.S. hospital database, the risk of AL observed with manual two-row circular staplers was similar to that seen with three-row devices. This study affirms the safety of manual two-row circular staplers in colorectal anastomosis.