Wheeler Andrew1, Jon Schram2, Keith Gersin3, Dmitri Stefanidis4, Jo-El Baudendistel5, Paula Veldhuis5* and Shyamin Mehra5
Background: Staple line integrity is of upmost importance to surgeons in gastric surgery. Staple line reinforcement is utilized to improve strength and stability of the staple line. The Echelon Endopath™ SLR (Staple Line Reinforcement, ESLR) was developed for staple line reinforcement. Our goal is to present results from a real-world study using the ESLR in gastric procedures.
Methods: A prospective, single-arm, multi-center, post-market study was performed to determine the incidence of device-related adverse events (AEs) through 70 days post-procedure in gastric procedures. AEs were defined as staple line bleeding, intra- or post-operative leak and radiographically documented stricture. Secondary outcomes were number of devices replaced intraoperatively due to bunching or slippage. Eligibility included subjects who underwent elective gastric resections in which ESLR was used.
Results: Of the 109 subjects enrolled, 98 completed the study with a mean age of 45.5 ± 11.3 years and a majority female (83.5%). All procedures were performed laparoscopically, with sleeve gastrectomy being the most commonly performed (77.1%), followed by Roux-en-Y gastric by-pass (22.9%) and other (0.9%). There were no reported cases of leak, bleeding, or strictures deemed device related though there was one intraoperative leak (anastomotic leak), which was deemed not related. Ten device replacements (out of 637 firings) occurred none of which was a result of slippage or bunching. Surgeons reported less frustration with set-up and ease-of-use of the device (100%), with the majority expressing strong or slight agreement that there was less buttress manipulation and movement during the procedure (75%).
Conclusion: In this study, the ESLR was shown to be effective and safe for buttressing staple lines during certain bariatric procedures.
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