The efficacy and safety of fluid gelatin for LSS undergoing PE-ULBD : a prospective, randomized controlled trial

Abstract

Background. Absorbable fluid gelatin is a novel collagen hemostatic agent that has been validated in multiple surgical procedures. However, the efficacy of using this hemostatic agent during percutaneous endoscopic unilateral laminectomy for bilateral decompression (PE-ULBD) remains controversial. Our research aims to conduct a prospective randomized controlled trial to investigate the efficacy and safety of this hemostatic material in patients undergoing PE-ULBD for lumbar spinal stenosis (LSS). Methods. From October2023 to February 2024, a total of 90 patients with LSS who underwent PE-ULBD, were enrolled in this study. The 90 patients were randomly divided into two groups: the TGTMS group (45 cases, using fluid gelatin) and the non-TGTMS group (45 cases, not using fluid gelatin). Primary outcomes included perioperative blood loss and intraoperative clotting time. Secondary outcomes encompassed surgical time, length of stay, hospital expenses, and complications. Results. There were statistically significant differences in primary outcomes which included perioperative blood loss and intraoperative clotting time between patients who received the TGTMS group and the control. The secondary outcomes of the two groups include surgical time, length of stay, hospital expenses and complications, among which only surgical time has significant statistical differences. Conclusions. When patients with LSS undergo PE-ULBD, the prophylactic use of fluid gelatin can reduce intraoperative and postoperative bleeding without any observed additional complications. Therefore, the prophylactic use of fluid gelatin in PE-ULBD is an effective and safe strategy. Trial registration: The study was registered on the Chinese Clinical Trial Registry website(www.chictr.org.cn) with registration number ChiCTR2300077538.