Background

Advanced bipolar devices seal and transect vessels to reduce blood loss and surgical complications during laparoscopic sleeve gastrectomy (LSG). ENSEAL X1 Curved Jaw Tissue Sealer (Ethicon Endo-Surgery, Inc.; Cincinnati, OH) is an advanced bipolar device with 360° continuous shaft rotation, and 16% longer jaw and 9% wider aperture compared to LIGASURE Maryland (Medtronic, PLC; Minneapolis, MN).This study compares effectiveness of ENSEAL X1 Curved Jaw Tissue Sealer (NSLX137C) and LIGASURE Maryland Jaw Open and laparoscopic Sealer/Divider with Nano-coating (LF1937) to seal vessels in an acute caprine LSG model. Gastroepiploic vessels along the greater curve of the abomasum were sealed and transected. After which, a hemostasis assessment was performed using a validated bleeding scale before and after manipulation to ensure seal integrity. Manipulation was performed by rolling the sealed vessel between the thumb and forefinger. The percent difference and a two-sided 95% confidence interval (CI) were calculated to establish equivalency at 10%. Average systemic, systolic blood pressure was 140 mmHg (SD=15.7, Range=120-195, N=482) and activated clotting time was 822 s (SD=188, Range=380-1,000, N=84) across all applications. Success rate for Enseal was 95.4% (230/241) vs Ligasure 95.9% (231/241) for a percent difference of -0.41% and 95% CI of -4.1% to 3.2% indicating equivalency (P<0.001). Success rate after manipulation for Enseal and Ligasure was equal, 94.2% (227/241) for a percent difference of 0% and 95% CI of -4.2% to 4.2% indicating equivalence (P<0.001). ENSEAL X1 Curved Jaw and LIGASURE Maryland provide equivalent effectiveness to seal vessels in an acute heparinized caprine LGS model.