A randomized controlled trial of the outcomes of Arista™ hemostatic agent in robotic ventral hernia repair

Ventral hernia repairs (VHR) are commonly performed surgical procedures in the United States, with over 300,000 cases treated annually. Robotic surgery has gained traction for its safety and efficacy in VHR, particularly with techniques such as myofascial release. However, the extensive dissection involved in these procedures may lead to postoperative complications like seromas and hematomas. This study aims to assess the effectiveness of Arista (TM), an FDA-approved hemostatic agent, in reducing these complications during robotic-assisted laparoscopic VHR involving mesh placement in the retrorectus space. This single-institution single-blind prospective randomized controlled trial involved 100 patients undergoing elective robotic-assisted laparoscopic VHR at a tertiary referral hernia center. Participants were randomized to receive either 5 g of Arista (TM) or standard of care intraoperatively, with no hemostat applied in the control group. All patients had drains placed in the retrorectus space. Primary outcomes included drain output on the first postoperative day (POD), total drain output, and duration of drain placement. Secondary outcomes included estimated blood loss (EBL), number of drains used, operative time, and length of stay (LOS). This study was funded by Becton, Dickinson and Company (BD). The mean total drain output was significantly higher in the Arista (TM) group (592.8 ml) compared to the control group (407.9 ml; p = 0.01), with a 39.6% increase noted. However, no significant difference in drain output on the first postoperative day or drain duration was observed. Secondary outcomes revealed no statistically significant differences in EBL, number of drains, operative time, or LOS between the groups. While the application of Arista (TM) during robotic-assisted laparoscopic VHR resulted in increased total drain output, it did not significantly affect other postoperative metrics, including LOS and complications. Further research is warranted to explore the potential benefits of Arista (TM) in specific patient populations and surgical contexts.