Prospective Randomized Comparison of Linear Endostaplers During Laparoscopic Sleeve Gastrectomy

Prospective Randomized Comparison of Linear Endostaplers During Laparoscopic Sleeve Gastrectomy

Raftopoulos Y, Rajkumar S, Davidson E, Papasavas P.
Hartford Hospital, Hartford, CT, USA

Obesity Surgery, August 2022; 32:3472-3480
DOI: 10.1007/s11695-022-06240-4 | PMID: 35974292 | Trial registration: NCT04617574

60
Patients prospectively randomized
RCT
Highest level of clinical evidence
Blinded
Independent evaluator
Key finding: Prospective RCT (n=60). Both devices were equally safe and effective in terms of stapler characteristics, patient symptoms, hospital stay, and adverse events. AEON had significantly lower bleeding VAS scores in 4 of 5 laparoscopic images and 3 of 5 endoscopic images, assessed by a blinded independent evaluator.

Abstract

Purpose:
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.

Methods:
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 to 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.

Results:
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.

Conclusion:
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.

*Abstract text reproduced from the original publication with attribution to the authors and publisher. All rights remain with the respective copyright holders. Reproduced here for informational and educational purposes in accordance with applicable open-access licensing or fair use principles. For the definitive version, refer to the original publication via the link provided.

Clinical Relevance: This is one of the only prospective RCTs comparing 6-row endostaplers in sleeve gastrectomy. The blinded, independent evaluation methodology removes subjective bias from the hemostasis comparison. The conclusion that both devices are equally safe and effective, with the specific advantage of lower bleeding scores favoring AEON, provides bariatric surgeons with the highest level of evidence for stapler selection in LSG.

Check Out Our Blogs

Try AEON™ Powered
In Your OR

See how AEON™ delivers better outcomes—and try it risk‑free.