Prospective Randomized Comparison of Linear Endostaplers During Laparoscopic Sleeve Gastrectomy.

Abstract

The development of Laparoscopic Linear Endostaplers (LLES) is crucial in minimally invasive approaches in bariatric surgery, but there have been very few published studies comparing 6-row LLES in Laparoscopic Sleeve Gastrectomy (LSG). The objective of this study was to compare two 6-row LLES in LSG. A total of 60 patients were prospectively randomized to undergo LSG with either Medtronic Endo GIA™ Tri-Staple technology (MTS) or AEON ™ Endostapler(Lexington Medical) LLES. The measured parameters included patient demographics, comorbidity indices, LLES and specimen characteristics, postoperative symptoms, hospital stay, and total adverse events (AEs). Intraoperative bleeding was evaluated using five laparoscopic and corresponding endoscopic images of staple line before clip application, compared with a 1-5 Visual Analogue Scale (VAS), assessed by an independent bariatric surgeon who was blinded to the LLES used. Images of all cases were reviewed on the same day to increase test-retest reliability. Both groups were similar in patient demographics. Compared to MTS, AEON LLES group had significantly lower bleeding VAS scores in 4/5 laparoscopic images (pre-pyloric: 1.7 ± 0.7 vs. 2.36 ± 0.76, p = 0.0007, mid-sleeve: 1.46 ± 0.62 vs. 1.86 ± 0.68, p = 0.019, proximal sleeve: 1.6 ± 0.77 vs. 2.0 ± 0.83, p = 0.038, gastro-esophageal junction: 1.43 ± 0.67 vs. 1.86 ± 0.77, p = 0.014) and 3/5 endoscopic images (pre-pyloric: 1.56 ± 0.56 vs. 2.36 ± 0.76, p = 0.006, incisura: 1.66 ± 0.54 vs. 2.0 ± 0.52, p = 0.021, mid-sleeve: 1.63 ± 0.49 vs. 2.0 ± 0.45, p = 0.005). There was no statistical difference in other parameters. Both devices were equally safe and effective in terms of LLES and specimen characteristics, patient symptoms, hospital stay, and AEs. Bleeding VAS scores were significantly lower, favoring the AEON LLES.