BACKGROUND: Only one previous study has evaluated the clinical safety of the 2 laparoscopic linear stapling devices available. Our study compared these staplers using laparoscopic gastric bypass as the standard procedure. METHODS: A total of 400 consecutive patients were prospectively studied. Group A (200 patients) underwent gastric bypass with the Endo-GIA Universal 6-row stapler (Autosuture) used, and group B (200 patients) underwent the procedure with the Ethicon 6-row stapler used. The measured parameters included stapler misfires, staple line bleeding, staple line leaks, unexplained gastrointestinal bleeding, unexplained intra-abdominal bleeding, total bleeding events, and total adverse events. RESULTS: Both groups were similar in preoperative body mass index, age, and gender. Both groups had a single staple line leak (0.5%; P = 1.0). Three (0.25% of staple firings) misfires occurred in group B. No misfires occurred in group A (P = .25). Gastrointestinal bleeding, staple line bleeding, and unexplained intra-abdominal bleeding occurred in 6 (3%), 2 (1%), and 5 (2.5%) patients in group A and in 1 (0.5%), 0 (0%), and 2 (1%) patients in group B (P = .12, P = .5, and P = .45, respectively). Total bleeding events occurred in 13 patients (6.5%) in group A and in 3 patients (1.5%) in group B (P = 0.019). The total number of patients with an adverse event was 14 (7%) in group A and 7 (3.5%) in group B (P = .18). CONCLUSION: The results of our study have shown that the Ethicon 6-row stapler had more misfires and the Autosuture Endo-GIA 6-row stapler resulted in more bleeding complications. Only the difference in total bleeding events reached statistical significance but the difference in the total number of adverse events was not statistically significant. Therefore, in our experience both devices were equally safe and effective.
RCT Entities:
BACKGROUND: Only one previous study has evaluated the clinical safety of the 2 laparoscopic linear stapling devices available. Our study compared these staplers using laparoscopic gastric bypass as the standard procedure. METHODS: A total of 400 consecutive patients were prospectively studied. Group A (200 patients) underwent gastric bypass with the Endo-GIA Universal 6-row stapler (Autosuture) used, and group B (200 patients) underwent the procedure with the Ethicon 6-row stapler used. The measured parameters included stapler misfires, staple line bleeding, staple line leaks, unexplained gastrointestinal bleeding, unexplained intra-abdominal bleeding, total bleeding events, and total adverse events. RESULTS: Both groups were similar in preoperative body mass index, age, and gender. Both groups had a single staple line leak (0.5%; P = 1.0). Three (0.25% of staple firings) misfires occurred in group B. No misfires occurred in group A (P = .25). Gastrointestinal bleeding, staple line bleeding, and unexplained intra-abdominal bleeding occurred in 6 (3%), 2 (1%), and 5 (2.5%) patients in group A and in 1 (0.5%), 0 (0%), and 2 (1%) patients in group B (P = .12, P = .5, and P = .45, respectively). Total bleeding events occurred in 13 patients (6.5%) in group A and in 3 patients (1.5%) in group B (P = 0.019). The total number of patients with an adverse event was 14 (7%) in group A and 7 (3.5%) in group B (P = .18). CONCLUSION: The results of our study have shown that the Ethicon 6-row stapler had more misfires and the Autosuture Endo-GIA 6-row stapler resulted in more bleeding complications. Only the difference in total bleeding events reached statistical significance but the difference in the total number of adverse events was not statistically significant. Therefore, in our experience both devices were equally safe and effective.
Authors: George A Giannopoulos; Nikolaos E Tzanakis; George E Rallis; Stamatis P Efstathiou; Christos Tsigris; Nikolaos I Nikiteas Journal: Surg Endosc Date: 2010-04-16 Impact factor: 4.584