Risk of anastomotic leakage with two-row versus three-row manual circular staplers in colorectal anastomosis: a U.S. cohort study

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.