Clinical outcomes of pre-attached reinforced stapler reloads in bariatric surgery: A prospective case series

Abstract

Background: Staple line reinforcement during surgery may decrease morbidity or reduce the risk of staple line leaks and bleeding. There is debate regarding the benefit, safety, and best form of reinforcement. This case series characterizes the safety of a stapler with a pre-attached buttress in bariatric surgeries. Methods: This prospective, multicenter, post-market study examined the use of stapler reloads with built in reinforcement material. The primary endpoint is the incidence of reported device-related adverse events up to 30 days after laparoscopic Roux-en-Y gastric bypass (RYGB) and laparoscopic sleeve gastrectomy (SG) surgeries. Specific outcomes included bleeding ( 50 mL), leaks, and 30-day readmissions. Outcomes: A total of 51 patients (19 RYGB, 32 SG) were assessed after exclusion criteria were applied. Intraoperatively, no leaks or bleeding related to the staple line occurred. Four patients (8% overall, 3 RYGB, 1 SG) experienced bleeding unrelated to the staple line and staple line intervention, in these cases, was not required. Four subjects (8%, all SG) required readmission and each were attributed as unrelated to the investigational device. No unanticipated device-related events were observed. Two adverse events (bleeding) occurred post-operatively that were attributed as possibly related to the device; both were endoscopically managed. Conclusions: This study demonstrates that there were no serious safety concerns from the AEs observed related to reinforced reload use during or in the 30-day course after 51 common bariatric procedures in a multicenter setting.