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

Tongtong Wang; Mordechai Sadowsky; Rebekah Blakney; Paul Coplan; William Petraiuolo; Mark Soberman; Joerg Tomaszewski; Lexi Rene; Jennifer Wood

doi:10.1007/s00384-023-04552-0

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

Int J Colorectal Dis. 2023 Nov 7;38(1):264. doi: 10.1007/s00384-023-04552-0.

Authors

Tongtong Wang¹, Mordechai Sadowsky², Rebekah Blakney³, Paul Coplan³, William Petraiuolo², Mark Soberman², Joerg Tomaszewski⁴, Lexi Rene³, Jennifer Wood³

Affiliations

¹ Epidemiology & Real-World Data Sciences, MedTech, Johnson & Johnson, New Brunswick, NJ, USA. TWang124@its.jnj.com.
² Medical Safety, MedTech, Johnson & Johnson, New Brunswick, NJ, USA.
³ Epidemiology & Real-World Data Sciences, MedTech, Johnson & Johnson, New Brunswick, NJ, USA.
⁴ Medical Affairs, MedTech, Johnson & Johnson, Raritan, NJ, USA.

Abstract

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.

Keywords: Anastomotic leak; Left-sided colorectal surgery; Manual circular staplers; Premier Healthcare Database (PHD); Retrospective cohort study.

MeSH terms

Adult
Anastomosis, Surgical / adverse effects
Anastomotic Leak* / etiology
Cohort Studies
Colorectal Neoplasms* / surgery
Humans
Retrospective Studies
Surgical Staplers / adverse effects
Surgical Stapling / adverse effects