Prospective Randomized Comparison of Linear Staplers during Laparoscopic Roux-en-Y Gastric Bypass

Background: The development of laparoscopic linear staplers has enabled minimally invasive approaches to bariatric surgery, but there have been no comparison studies of the two current 6-row devices. We report our experience with a prospective randomized comparison of 6-row linear staplers during laparoscopic Roux-en-Y gastric bypass (LRYGBP). Methods: From January to March 2003, 100 patients were randomly assigned to undergo LRYGBP with either an Endo-GIA Universal 6-row stapler (USSC) or the ETS-Flex 6-row stapler (Ethicon). Mean preoperative BMI was 49±8 for 50 Endo-GIA patients, and 49±7 for 50 ETS-Flex patients. Parameters measured included quantity of cartridges, handles, hemoclips, estimated blood loss, misfires, OR time, postoperative leaks and bleeds, and cost. Results: Mean follow-up was 135 days (range 90- 180). The ETS-Flex group experienced significantly more misfires (28% vs 2%, P <.001), hemoclips applied (30±9 vs 21±7, P <.001), estimated blood loss (132±56 vs 100±32 ml, P <.001) and OR time (66±19 vs 58±13 mins, P <.02) compared with the Endo-GIA group respectively.There was one postoperative leak associated with the ETS-Flex group and two postoperative bleeds with the Endo-GIA group, which were not a significant differences.The Endo-GIA group averaged $319 more per case for staple cost. Conclusion: While the ETS-Flex stapler was less expensive, it was associated with more technical failures requiring surgeon intervention to reduce potential patient morbidity, compared with the Endo-GIA.