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

Woo Young Kim, Jae Bok Lee, Hoon Yub Kim, Pyoung Jae Park, Seung Pil Jung, Hye Yoon Lee, Jae Gu Cho, Kyoung Sik Park, Min Jeng Cho

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)452-460
Number of pages9
JournalInternational Surgery
Volume103
Issue number9-10
DOIs
Publication statusPublished - 2019 Sep

Fingerprint

Poloxamer
Thyroidectomy
Double-Blind Method
Multicenter Studies
Polysaccharides
Gels
Safety
Althaea
Deglutition
alginic acid
Vocal Cords

Keywords

  • Sodium hyaluronate
  • Surgery-induced tissue adhesions
  • Thyroid

ASJC Scopus subject areas

  • Surgery

Cite this

Prospective, randomized, double blind, multicenter study for an autocrosslinked polysaccharide gel to evaluate antiadhesive effect and safety compared to poloxamer/ sodium alginate after thyroidectomy. / Kim, Woo Young; Lee, Jae Bok; Kim, Hoon Yub; Park, Pyoung Jae; Jung, Seung Pil; Lee, Hye Yoon; Cho, Jae Gu; Park, Kyoung Sik; Cho, Min Jeng.

In: International Surgery, Vol. 103, No. 9-10, 09.2019, p. 452-460.

Research output: Contribution to journalArticle

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AU - Kim, Hoon Yub

AU - Park, Pyoung Jae

AU - Jung, Seung Pil

AU - Lee, Hye Yoon

AU - Cho, Jae Gu

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N2 - 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.

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