Comparison of Laparoscopic Linear Staplers in Clinical Use
Abstract & Commentary
By Namir Katkhouda, MD, FACS, Professor of Surgery, Chief, Minimally Invasive Surgery, University of Southern California (USC)-Los Angeles, CA. Dr. Katkhouda is a consultant for Baxter, Ethicon, Storz, and Gore.
Synopsis: The results have shown that the Ethicon 6-row stapler had more misfires and the Autosuture Endo-GIA 6-row stapler resulted in more bleeding complications.
Source: Simper SC, et al. Comparison of laparoscopic linear staplers in clinical patients. Surg Obes Relat Dis. 2007;30:Epub ahead of print.
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.
Commentary
This paper compared 2 staplers from different manufactures and found that one was more hemostatic than the other, while the other had had less staple misfiring. The study has some methodological limitations: the comparison was made between 2 different surgeons, each using a different stapler, thus introducing a big variable. Data was also analyzed retrospectively, further weakening the results. This study contradicts a previous paper by Champion. In his study, Champion randomized 100 patients and found exactly opposite results. Therefore, in the absence of a good scientific study, no conclusion can be definitively drawn. Our results are similar to Champion's. In more than 1200 procedures using the same stapler, we had 5 severe bleeding episodes leading to 4 take backs to the operating room. We now have, together with the majority of the surgeons, started using buttress material to increase the thickness and render the staple lines more hemostatic. We also add clips and other glues to ensure better hemostasis.
The perfect staple line represents a big challenge to most companies, as they have to juggle between a perfectly formed staple that will reduce leaks and achieve better hemostasis, and avoid ischemia of the compressed tissue. They also have to incorporate the notion that within the same organ, the thicknesses may vary from one area to another, as well as gender-related variations; male tissues tend to be thicker.
The future possibly resides in the development of intelligent staplers that will sense tissue thickness.
Postoperatively, it is prudent to check hematocrit and hemoglobin levels before discharge to recognize an early postoperative bleed.