Improving Hemostasis in Sleeve Gastrectomy With Alternative Stapler.

BACKGROUND: Staple line bleeding can be a major intra-operative complication during laparoscopic sleeve gastrectomy, requiring reinforcing interventions that may diminish the integrity of the staple line and put patients at risk for postoperative hemorrhage or leak. To improve outcomes associated with surgery, surgeons may benefit from an alternative stapler that produces a drier staple line and requires less staple line manipulation. METHODS: Sixty consecutive laparoscopic sleeve gastrectomy procedures were performed by three surgeons; 30 sleeves using the AEON™ Endostapler on THICK MODE and 30 using the Echelon Flex™ Powered Stapler with pulse technique. Stapler performance was measured by incidence and degree of staple line bleeding. Images of the first firing and fundus were taken with the laparoscope 10 seconds after the final firing. Images were evaluated by a third-party blinded evaluator and given a "bleeding score," a qualitative measure of intra-operative staple-line bleeding (1 = no bleeding to 5 = profuse bleeding). RESULTS: The AEON™ Endostapler demonstrated a lower mean (± standard error) "bleeding score" versus the Echelon Flex™ (2.1 ± 0.1 vs. 2.6 ± 0.1; p = 0.01). The AEON™ Endostapler had 15 cases (50%) with no bleeding at the fundus; the Echelon Flex™ had 7 cases (23%) with no bleeding at the fundus. The AEON™ Endostapler had 0 cases (0%) with profuse bleeding; the Echelon Flex™ had 2 cases (7%) with profuse bleeding. CONCLUSION: The AEON™ Endostapler is a significantly drier alternative to the Echelon Flex™ Powered Stapler, producing a much drier staple line and decreasing the need for other bleeding control methods.

Randomized sham-controlled trial evaluating efficacy and safety of endoscopic gastric plication for primary obesity: The ESSENTIAL trial.

OBJECTIVE: Evaluate safety and efficacy of the pose™ procedure for obesity treatment. METHODS: Subjects with Class I to II obesity were randomized (2:1) to receive active or sham procedure, after each investigator performed unblinded lead-in cases. All subjects were provided low-intensity lifestyle therapy. Efficacy end points were the mean difference in percent total body weight loss (%TBWL) at 12 months between randomized groups, and responder rate achieving ≥5% TBWL. The primary safety end point was incidence of reported adverse events. RESULTS: Three hundred thirty-two subjects were randomized (active, n = 221; sham, n = 111); thirty-four subjects were included in the unblinded lead-in cohort. Twelve-month results were mean TBWL 7.0 ± 7.4% in lead-in, 4.95 ± 7.04% in active, and 1.38 ± 5.58% in sham groups, respectively. Responder rate was 41.55% in active and 22.11% in sham groups, respectively (P < 0.0001); mean responder result was 11.5% TBWL. The differences observed between active and sham groups for co-primary end points were statistically significant (P < 0.0001); however, super superiority margin as set forth in the study design was not met. No unanticipated adverse events or deaths occurred. Procedure-related serious adverse event rates were 5.0% (active) and 0.9% (sham), P = 0.068. CONCLUSIONS: The pose procedure was safe and resulted in statistically significant and clinically meaningful weight loss over sham through 1 year.