Dataset Information

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

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).

SUBMITTER: Lee DY

PROVIDER: S-EPMC7515784 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Lee Dong Yun DY Lee Sa Ra SR Kim Seul Ki SK Joo Jong Kil JK Lee Woo Shun WS Shin Jung Ho JH Cho SiHyun S Park Joon Cheol JC Kim Sung Hoon SH

Yonsei medical journal 20201001 10

<h4>Purpose</h4>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.<h4>Materials and methods</h4>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 (Hyalobar ...[more]

PMID: 32975061

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Project description:The electrothermal effect of hysteroscopic bipolar electrosurgical resection may cause damage to the endometrium, leading to intrauterine adhesion (IUA). Although some studies have demonstrated the efficacy and feasibility of auto-cross-linked hyaluronic (ACP) gel in preventing IUAs, controversy over its use continues. In this randomized controlled multi-center 2-arm parallel trial, we aimed to examine the efficacy and safety of ACP gel in preventing IUA after hysteroscopic electrosurgical resection and facilitate pregnancy in patients. Patients from 4 centers in China were randomly assigned (1:1) to receive an intrauterine infusion of ACP gel or nothing after hysteroscopic electrosurgical resection. The randomization assignment was generated by computer and kept in a sealed envelope. A second-look hysteroscopy was performed within 3 months of the surgery. From June 2018 to May 2021, 200 patients were recruited. Ultimately, 82 patients in both groups were included in the result analysis. The baseline characteristics were comparable. The outcomes were assessed by using per-protocol analysis. The incidence of IUA in the ACP gel group was lower than that in the control group [3.66% vs. 10.98%, risk ratio (RR) =0.333, 95% confidence interval (CI): 0.094-1.187, P=0.072], and the planned pregnancy rate was higher than that of the control group (60.98% vs. 40.54%, RR =1.504, 95% CI: 0.949-2.384, P=0.071), but the difference was not statistically significant. There was no significant difference in menstruation change. Menstrual volume remained unchanged in most cases (86.59% in ACP gel group vs. 89.02% in the control group, RR =0.877, 95% CI: 0.877-1.109, P=0.815). Menstrual volume decreased in 10 women in the ACP gel group and 8 in the control group (12.20% vs. 9.76%, RR =1.250, 95% CI: 0.520-3.007, P=0.617). No adverse effects were observed after the ACP administration. The present study showed that the use of ACP gel appeared to reduce both the tendency of IUA and American Fertility Society (AFS) scores and improve the subsequent pregnancy rate during hysteroscopic electrosurgical resection when treating polyps, fibroids, and uterine septum. ACP might be recommended to prevent IUA after such surgery. Further studies should be conducted with larger numbers of participants. Chinese Clinical Trial Registry ChiCTR2100047165.

Project description:BackgroundIntrauterine adhesions (IUAs) are a benign uterine disorder that results in intrauterine adhesions and scarring. This study was conducted to assess the effects of freeze-dried amnion grafts on the concentrations of adhesion-related cytokines in uterine exudates following hysteroscopic adhesiolysis of IUAs.Materials and methodsThis study was a prospective randomized controlled trial. Thirty patients who underwent hysteroscopic adhesiolysis for severe IUAs were enrolled. They were randomly divided into a study group (with freeze-dried amnion graft treatment after surgery, N = 15) and a control group (without a graft, N = 15). After complete separation of adhesions, a Foley balloon containing a freeze-dried amnion graft was inserted into the uterine cavity in the study group, while a Foley balloon with no graft was placed in the control group. Enzyme-linked immunosorbent assays were performed to test adhesion-related cytokine concentrations in uterine exudates, including IL-1β, TNF-α, and VEGF, at different time intervals after surgery. Second-look hysteroscopy was conducted three months after the surgery. On the basis of the American Fertility Society (AFS) scoring system, the level of adhesions was evaluated during hysteroscopy.ResultsThe postoperative volume of the uterine exudates in the study group was significantly lower than that of the control group (P < 0.05). The adhesion-related cytokine concentrations of TNF-α, VEGF, and IL-1β significantly increased after surgery in both groups. Their concentrations were significantly lower in the study group than in the control group (P < 0.05). Moreover, IL-1β exhibited a long-lasting effect in the study group. AFS scores and readhesion rates were significantly lower in the study group than in the control group after hysteroscopic adhesiolysis of severe IUAs.ConclusionThe application of freeze-dried amnion grafts is beneficial to the postoperative recovery of patients with severe IUAs and may reduce the readhesion rate after hysteroscopic adhesiolysis by lowering adhesion-related cytokines, including TNF-α, VEGF, and IL-1β.

Dataset Information

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

Purpose

Materials and methods

Results

Conclusion

Publications

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

Similar Datasets

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