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.
RCT Entities:
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.
Authors: S Sauerland; L Angrisani; M Belachew; J M Chevallier; F Favretti; N Finer; A Fingerhut; M Garcia Caballero; J A Guisado Macias; R Mittermair; M Morino; S Msika; F Rubino; R Tacchino; R Weiner; E A M Neugebauer Journal: Surg Endosc Date: 2004-12-02 Impact factor: 4.584