The development of laparoscopic linear endo-staplers (LLES) has enabled minimally invasive approaches to bariatric surgery, but there are few published randomized clinical trials comparing LLES in sleeve gastrectomy (LSG). The objective of this study was to compare two LLES in LSG.
Sixty consecutive patients were prospectively randomized to undergo LSG with either the tri-staple technology (Medtronic) or the AEON (Lexington Medical) LLES. The measured parameters included patient demographics, LLES characteristics, patient symptoms, hospital stay, specimen characteristics, and adverse events (AEs) (stapler misfires, staple line leaks, and postoperative bleeding). Postoperative bleeding was examined by blood transfusion; hemoglobin difference (preoperative to recovery room and 24 hours postoperatively); non-routine staple line clipping; and evaluation of five laparoscopic and corresponding endoscopic images for staple line bleeding (pre-pyloric, incisura, mid-sleeve, proximal sleeve and gastro-esophageal junction) with a 0-5 visual analogue score (VAS) assessed by an independent blinded bariatric surgeon.
Both groups were similar in patient demographics. There was a significant difference in favor of the AEON LLES in 4/5 laparoscopic images (pre-pyloric: 1.7+0.7 vs. 2.36+0.76, p=0.007, 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 the other measured parameters.
Both devices were equally safe and effective in terms of LLES characteristics, patient symptoms, pathology characteristics, hospital stay, and AEs. Bleeding VASs were significantly lower with the AEON LLES.