Prospective, randomized, double blind, multicenter study for an autocrosslinked polysaccharide gel to evaluate antiadhesive effect and safety compared to poloxamer/ sodium alginate after thyroidectomy

Abstract

The aim of the study was to compare the efficacy and safety between an autocrosslinked polysaccharide (ACP) gel (Hyalobarrier) and a poloxamer/sodium alginate (P/SA: Guardix-SG) in preventing adhesions after thyroidectomy and demonstrate the noninferiority of ACP gel to P/SA. To identify differences of antiadhesive efficacy and safety between the ACP gel and P/SA, we investigated various variables such as the proportion of normal esophageal motility as assessed using marshmallow esophagography, swallowing impairment, adhesion severity and so on. This prospective, randomized, double-blinded, multicenter, phase III study investigated the antiadhesive efficacy and safety of ACP gel compared with those of P/SA for 12 weeks. Subjects were randomly assigned to receive either ACP gel (n ¼ 97) or P/SA (n ¼ 96). The primary endpoint was the proportion of normal esophageal motility as assessed using marshmallow esophagography, while the secondary endpoints included swallowing impairment, adhesion severity, laryngoscopic assessment of the vocal cords, and voice range profile. Safety endpoints included adverse events. There was no significant difference between the ACP gel and P/SA groups in the proportion of normal esophageal motility as the primary endpoint (P ¼ 0.7428). In addition, there were no differences in the secondary or safety endpoints between the 2 groups. It was demonstrated that ACP gel was not inferior to P/ SA. ACP gel appears both effective and safe for use in preventing adhesions after thyroidectomy.