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

International Journal of Colorectal Disease - Tập 38 - Trang 1-16 - 2023
Tongtong Wang1, Mordechai Sadowsky2, Rebekah Blakney1, Paul Coplan1, William Petraiuolo2, Mark Soberman2, Joerg Tomaszewski3, Lexi Rene1, Jennifer Wood1
1Epidemiology & Real-World Data Sciences, MedTech, New Brunswick, USA
2Medical Safety, MedTech, New Brunswick, USA
3Medical Affairs, MedTech, Raritan, USA

Tóm tắt

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. 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. 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). 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.

Tài liệu tham khảo

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