Samuel Szomstein, MD, FACS1, Joel S Frieder, MD2, Natan Zundel, MD, FACS3. 1Cleveland Clinic Florida, 2Universidad Central de Venezuela, 3Florida International University – Herbert Wertheim College of Medicine
Background: Porcine models have been widely accepted for gastrointestinal surgery studies, due to their similarities to human anatomy, histology and physiology. Devices such as laparoscopic staplers have been widely used in bariatrics and are currently the cornerstone of bariatric. There are currently few published articles regarding surgical stapler testing in porcine models by means of a survival design. The purpose of this study is to present a new model for stapler testing in porcines. We present the following study in which we asses a novel stapler’s feasibility and safety, and its compatibility to currently used stapler reloads. This novel stapler, the AEON™ Endoscopic Linear Stapler (Lexington Medical Inc., Billerica, MA. Pending FDA approval), has been previously tested In-Vitro and In-Vivo by the Lexington Medical engineering department in matters of mechanical function, staple line bursting pressure, staple formation and hemostasis. Duffy et al. used this instrument for small bowel anastomoses in a two-week survival study in porcine models.
Methods and procedures: Four porcine animal model was used under IACUC protocol for a 29-day survival study held at the FIU (Doral, FL, U.S.A) research facility. All animals underwent sleeve gastrectomy using the novel stapler handle, combined with the Endo GIA™ (Medtronic, Mansfield, MA) 4mm-staple reloads in two of the animals and AEON™ 4mm-staple reloads in the remaining two. No reinforcements or oversewing of the staple line was done. These procedures were performed by two bariatric surgeons. Animals were monitored perioperatively by the facility staff as per protocol. The animals were euthanized at day 29. Post-mortem assessments were done blindly. Gross evaluation and comparison of the gastric tube and their staple lines was done, as well as patency, strictures, and staple line integrity.
Results: Stapler function was equivalent with both reload brands, no technical issues were encountered. 3-5 firings were used per animal. No intraoperative complications related to stapler function ensued. No postoperative complications were encountered. All animals survived the full length of the study -29 days-. All sleeves were patent, no strictures or bowel obstruction were present.
Conclusions: In an animal survival study, a follow-up period of 4 weeks appears to be a good benchmark for stapler testing. The use of the novel stapler for gastric resections appears feasible and safe. Further studies such as microscopic examination of the staple lines, might help confirm equivalence, safety and feasibility of these products for the sleeve gastrectomy procedure.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 85004
Program Number: P498
Presentation Session: iPoster Session (Non CME)
Presentation Type: Poster