Evaluation of the AEON Powered Stapler System in Primary Sleeve Gastrectomy: Results of a Prospective Clinical Trial
Source: PubMed Central Open Access, NCBI / U.S. National Library of Medicine
Purpose Staple-line complications such as bleeding and leaks remain clinically relevant in sleeve gastrectomy despite advances in surgical technique and device technology. This prospective trial was conducted to investigate the hypothesis that the AEON Powered Stapling System could improve consistency and stability of firing intraoperatively, which could lead to less tissue trauma, improved hemostasis, and fewer intra- and post-operative complications. Materials and Methods This was a prospective, single-center, single-arm study including 50 consecutive patients undergoing primary sleeve gastrectomy using the AEON Powered Stapling System. The primary endpoint was postoperative staple-line complications requiring intervention (bleeding or leak). Intraoperative hemostasis was assessed using a visual analogue scale (VAS). Postoperative outcomes and early quality-of-life (QOL) changes were evaluated. Results Fifty patients (49 female; mean age 38.5±7.4 years; mean body mass index 35.8±3.7 kg/m) underwent sleeve gastrectomy. Mean intraoperative VAS bleeding score was 1.04±0.19. No intraoperative bleeding requiring intervention occurred. There were no postoperative staple-line bleeds, leaks, reoperations, or device-related adverse events. Mean hemoglobin decrease was clinically insignificant, and no blood transfusions were required. Early postoperative pain scores were low and decreased progressively until discharge. In an exploratory analysis, improvement in five 36-Item Short For
Abstract
Purpose Staple-line complications such as bleeding and leaks remain clinically relevant in sleeve gastrectomy despite advances in surgical technique and device technology. This prospective trial was conducted to investigate the hypothesis that the AEON Powered Stapling System could improve consistency and stability of firing intraoperatively, which could lead to less tissue trauma, improved hemostasis, and fewer intra- and post-operative complications. Materials and Methods This was a prospective, single-center, single-arm study including 50 consecutive patients undergoing primary sleeve gastrectomy using the AEON Powered Stapling System. The primary endpoint was postoperative staple-line complications requiring intervention (bleeding or leak). Intraoperative hemostasis was assessed using a visual analogue scale (VAS). Postoperative outcomes and early quality-of-life (QOL) changes were evaluated. Results Fifty patients (49 female; mean age 38.5±7.4 years; mean body mass index 35.8±3.7 kg/m) underwent sleeve gastrectomy. Mean intraoperative VAS bleeding score was 1.04±0.19. No intraoperative bleeding requiring intervention occurred. There were no postoperative staple-line bleeds, leaks, reoperations, or device-related adverse events. Mean hemoglobin decrease was clinically insignificant, and no blood transfusions were required. Early postoperative pain scores were low and decreased progressively until discharge. In an exploratory analysis, improvement in five 36-Item Short Form Health Survey QOL domains was observed at 3 weeks. Conclusion The AEON Powered Stapling System was safe and effective and demonstrated low intraoperative staple-line bleeding scores and a favorable short-term safety profile in primary sleeve gastrectomy. Because this was a single-arm study without a comparator group, larger comparative studies with longer follow-up are warranted. Trial Registration ClinicalTrials.gov Identifier: