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A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial

Authors
 Dong Yun Lee  ;  Sa Ra Lee  ;  Seul Ki Kim  ;  Jong Kil Joo  ;  Woo Shun Lee  ;  Jung Ho Shin  ;  SiHyun Cho  ;  Joon Cheol Park  ;  Sung Hoon Kim 
Citation
 YONSEI MEDICAL JOURNAL, Vol.61(10) : 868-874, 2020-10 
Journal Title
YONSEI MEDICAL JOURNAL
ISSN
 0513-5796 
Issue Date
2020-10
MeSH
Adult ; Female ; Gels / administration & dosage* ; Gels / therapeutic use ; Humans ; Hyaluronic Acid / administration & dosage* ; Hyaluronic Acid / therapeutic use ; Hysteroscopy / adverse effects* ; Incidence ; Postoperative Complications / prevention & control* ; Pregnancy ; Prospective Studies ; Republic of Korea ; Severity of Illness Index ; Tissue Adhesions / etiology ; Tissue Adhesions / prevention & control* ; Treatment Outcome ; Uterine Diseases / etiology ; Uterine Diseases / surgery*
Keywords
Hysteroscopy ; hyaluronic acid ; infertility ; tissue adhesions ; uterus
Abstract
Purpose: To investigate the efficacy and safety of a newly developed thermo-responsive sol-gel, ABT13107, for reducing the formation of intrauterine adhesions (IUAs) after hysteroscopic surgery.

Materials and methods: In this multicenter, prospective, randomized trial (Canadian Task Force classification I), 192 women scheduled to undergo a hysteroscopic surgery at one of the eight university hospitals in South Korea were randomized into the ABT13107 group or the comparator (Hyalobarrier®) group in a 1:1 ratio. During hysteroscopic surgery, ABT13107 or Hyalobarrier® was injected to sufficiently cover the entire intrauterine cavity.

Results: The patients returned to their respective sites for safety assessments at postoperative weeks 1 and 4 and for efficacy assessments at postoperative week 4. The post-surgery incidence of IUAs was 23.4% in the ABT13107 group and 25.8% in the comparator group; this difference met the criteria for ABT13107 to be considered as not inferior to the comparator. No differences were found in the extent of adhesions, types of adhesions, or the cumulative American Fertility Society score between the two treatment groups. Most adverse events were mild in severity, and no serious adverse events occurred.

Conclusion: ABT13107, a new anti-adhesive barrier containing hyaluronic acid, was not inferior to the highly viscous hyaluronic acid anti-adhesive barrier, Hyalurobarrier® in IUA formation after hysteroscopic surgery (Clinical trial registration No. NCT04007211).
Files in This Item:
T202007180.pdf Download
DOI
10.3349/ymj.2020.61.10.868
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers
Yonsei Authors
Cho, Si Hyun(조시현) ORCID logo https://orcid.org/0000-0003-2718-6645
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/183865
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