Efficacy and safety of a thermosensitive poloxamer-based hydrogel as an anti-adhesive agent in full-endoscopic spine surgery: a randomized controlled trial in Thailand

Information from the abstract

Study Design: Randomized controlled trial. Purpose: This trial aimed to evaluate the efficacy and safety of a thermosensitive poloxamer-based anti-adhesive hydrogel in patients undergoing full-endoscopic lumbar discectomy for lumbar disc herniation. Overview of Literature: Epidural fibrosis is a complication following lumbar discectomy that is characterized by frequent pain generation. Although full-endoscopic discectomy causes minimal tissue trauma, fibrosis remains a cause of unsatisfactory outcomes. Although thermosensitive poloxamer-based anti-adhesive hydrogels have demonstrated anti-adhesive effects in animal models, clinical evidence for the same remains scarce. Methods: A single-center randomized controlled trial was conducted on 71 patients undergoing full-endoscopic interlaminar lumbar discectomy. Patients were randomized to receive either an anti-adhesive agent or methylprednisolone. The primary outcome was leg pain measured using the Visual Analog Scale (VAS)-leg 3 months after surgery. Secondary outcomes included VAS-back and the Oswestry Disability Index (ODI), assessed before and 1, 3, 6, and 12 months after surgery. Epidural fibrosis was graded based on magnetic resonance imaging (MRI) 3 months after surgery. Results: Baseline characteristics were comparable between the groups. Both groups demonstrated significant improvements in VAS and ODI scores from baseline at all timepoints (p

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Related topics: Hemostasis and retained surgical items · Surgical Sutures and Adhesives · Head and Neck Surgical Oncology