A New Thermo-Responsive Hyaluronic Acid Sol-Gel to Prevent Intrauterine Adhesions after Hysteroscopic Surgery: A Randomized, Non-Inferiority Trial
1
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
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. NCT 04007211).
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. NCT 04007211).
참고문헌 (26)
- Guida M, "Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery : a prospective, randomized, controlled study", Hum Reprod, 19, pp.1461~1464 (2004)
- Al-Inany H, "Intrauterine adhesions. An update", Acta Obstet Gynecol Scand, 80, pp.986~993 (2001)
- Risberg B, "Adhesions : preventive strategies", Eur J Surg Suppl, (577), pp.32~39 (1997)
- Farquhar C, "Barrier agents for preventing adhesions after surgery for subfertility", Cochrane Database Syst Rev, (2), pp.CD000475~ (2000)
- Watson A, "Liquid and fluid agents for preventing adhesions after surgery for subfertility", Cochrane Database Syst Rev, (2), pp.CD001298~ (2000)
- Li X, "New crosslinked hyaluronan gel for the prevention of intrauterine adhesions after dilation and curettage in patients with delayed miscarriage : a prospective, multicenter, randomized, controlled trial", J Minim Invasive Gynecol, 26, pp.94~99 (2019)
- Bosteels J, "Anti-adhesion therapy following operative hysteroscopy for treatment of female subfertility", Cochrane Database Syst Rev, (11), pp.CD011110~ (2015)
- Hellebrekers BW, "Use of fibrinolytic agents in the prevention of postoperative adhesion formation", Fertil Steril, 74, pp.203~212 (2000)
- Ferland R, "Evaluation of a sprayable polyethylene glycol adhesion barrier in a porcine efficacy model", Hum Reprod, 16, pp.2718~2723 (2001)
- diZerega GS, "A randomized, controlled pilot study of the safety and efficacy of 4% icodextrin solution in the reduction of adhesions following laparoscopic gynaecological surgery", Hum Reprod, 17, pp.1031~1038 (2002)
- Tsapanos VS, "The role of Seprafilm bioresorbable membrane in the prevention and therapy of endometrial synechiae", J Biomed Mater Res, 63, pp.10~14 (2002)
- Lin X, "A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome : a cohort study", Eur J Obstet Gynecol Reprod Biol, 170, pp.512~516 (2013)
- Liu C, "A randomized controlled trial on the efficacy and safety of a new crosslinked hyaluronan gel in reducing adhesions after gynecologic laparoscopic surgeries", J Minim Invasive Gynecol, 22, pp.853~863 (2015)
- Acunzo G, "Effectiveness of auto-cross-linked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic adhesiolysis : a prospective, randomized, controlled study", Hum Reprod, 18, pp.1918~1921 (2003)
- Huberlant S, "Application of a hyaluronic acid gel after intrauterine surgery may improve spontaneous fertility : a randomized controlled trial in New Zealand White rabbits", PLoS One, 10, pp.e0125610~ (2015)
- The American Fertility Society, "The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, müllerian anomalies and intrauterine adhesions", Fertil Steril, 49, pp.944~955 (1988)
- Di Spiezio Sardo A, "Efficacy of a polyethylene oxide-sodium carboxymethylcellulose gel in prevention of intrauterine adhesions after hysteroscopic surgery", J Minim Invasive Gynecol, 18, pp.462~469 (2011)
- Taskin O, "Role of endometrial suppression on the frequency of intrauterine adhesions after resectoscopic surgery", J Am Assoc Gynecol Laparosc, 7, pp.351~354 (2000)
- Liakakos T, "Peritoneal adhesions : etiology, pathophysiology, and clinical significance. Recent advances in prevention and management", Dig Surg, 18, pp.260~273 (2001)
- Pabuccu R, "Efficiency and pregnancy outcome of serial intrauterine deviceguided hysteroscopic adhesiolysis of intrauterine synechiae", Fertil Steril, 90, pp.1973~1977 (2008)
- Yang JH, "Optimal waiting period for subsequent fertility treatment after various hysteroscopic surgeries", Fertil Steril, 99, pp.2092~2096 (2013)
- Hooker AB, "Prevalence of intrauterine adhesions after the application of hyaluronic acid gel after dilatation and curettage in women with at least one previous curettage : short-term outcomes of a multicenter, prospective randomized controlled trial", Fertil Steril, 107, pp.1223~1231 (2017)
- Valachová K, "Hyaluronan in medical practice", Curr Med Chem, 23, pp.3607~3617 (2016)
- Liu H, "Efficacy and safety of hyaluronic acid gel for the prevention of intrauterine adhesion : a meta-analysis of randomized clinical trials", Gynecol Obstet Invest, 83, pp.227~233 (2018)
- AAGL Elevating Gynecologic Surgery, "AAGL practice report : practice guidelines on intrauterine adhesions developed in collaboration with the European Society of Gynaecological Endoscopy(ESGE)", Gynecol Surg, 14, pp.6~ (2017)
- Ludwig H, "Microarchitecture of the human endometrium by scanning electron microscopy : menstrual desquamation and remodeling", Ann N Y Acad Sci, 622, pp.28~46 (1991)