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 = 97) or P/SA (n = 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 = 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.

Anti-adhesive effect and safety of a thermosensitive adhesion barrier (Mediclore) for thyroid surgery: a double-blinded randomized controlled trial

“…First, there was no objective standard for evaluating the degree of adhesion; therefore, this study used a questionnaire with a 5-step evaluation scale to evaluate the degree of adhesion between patients and physicians. Although some studies have attempted to evaluate the degree of adhesion by objectively evaluating the movement of the esophagus, it has not yet been recognized as a standard evaluation index [ 6 18 ]. As there is no standard for objective indicators for evaluating adhesions after thyroid surgery, several studies have used surveys to determine the degree of adhesion [ 8 13 14 20 ].…”

“…Postoperative adhesions are natural postoperative reactions that occur in the tissues surrounding the surgical site. Due to adhesions, patients complain of dysphagia, persistent abnormal sensations or pain, movement disorders, and abnormal skin wrinkles [ 6 7 ]. Several studies related to the use of anti-adhesion agents to improve the quality of life of patients by preventing adhesions after thyroid surgery have been conducted, but they did not show any significant improvement in patients’ adhesion-related symptoms [ 5 6 8 ].…”

Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: A randomized, multicenter, double-blind, non-inferiority study

“…Although it is difficult to calculate the amount of adhesion, the phenotype of adhesion which is represented by dysfunction or certain symptoms of the patients can be evaluated by several measurements, and esophageal movement using marshmallow can be one of the choices. This is known to be useful as one of the good functional methods for detecting esophageal dysmobility and swallowing difficulty, which is triggered by the abnormal pharyngeal and upper esophageal muscle movement induced by post-thyroidectomy adhesion [ 31 , 32 ].…”