Safety and Effectiveness of an In Situ-Forming Hydrogel Barrier in Preventing Intrauterine Adhesions After Adhesiogenic Hysteroscopic Procedures: A Multicenter, Randomized, Controlled Trial.

内容摘要

To evaluate the safety and effectiveness of an in situ-forming intrauterine hydrogel barrier compared with no barrier in preventing intrauterine adhesions after adhesiogenic hysteroscopic surgery, and to assess changes in adhesion severity in the adhesiolysis cohort. Randomized, multicenter, subject- and evaluator-blinded trial conducted across 15 U.S. Academic and community-based gynecologic surgery centers. Premenopausal women >18 years undergoing hysteroscopic adhesiolysis for moderate to severe intrauterine adhesions or hysteroscopic myomectomy for FIGO Type 1 or 2 leiomyomas ≥1 cm, considered at risk for postoperative adhesions. Following completion of the index procedure, participants were randomized 2:1 to receive an in situ-forming intrauterine hydrogel barrier ("spacer") or no barrier. The primary endpoint was the proportion of participants without intrauterine adhesions at second-look hysteroscopy, as assessed by a blinded, independent central review committee using paired video evaluation. Change in adhesion severity from baseline to second-look hysteroscopy was a secondary endpoint. Safety outcomes included device and/or procedure-related adverse events from time of randomization through three weeks following the index procedure. Between August 2022 and January 2025, 150 participants were randomized (hydrogel barrier: n=99; control: n=51). In the intention-to-treat analysis, a greater proportion of hydrogel participants were adhesion-free at second-look than controls (68.7% vs 51.4%; p=0.017). In the adhesiolysis subgroup (n=102), more participants in the hydrogel barrier arm were adhesion-free compared with controls (60.3% vs 32.3%; OR 3.19, 95% CI: 1.29-7.90, p=0.015), and adhesion severity was reduced (6.3% vs 32.3%; OR 0.14, 95% CI: 0.04-0.50, p=0.002). In the leiomyoma subgroup (n=48), adhesion rates were 16.7% in the hydrogel group and 21.4% in controls; however, the estimated treatment effect was imprecise due to the limited subgroup sample size and wide confidence interval (OR 0.73, 95% CI: 0.15-3.62, p=0.70). No serious device-related adverse events were observed. In this multicenter randomized trial, use of an in situ-forming intrauterine hydrogel barrier with a 2- to 3-week residence time after adhesiogenic hysteroscopic procedures increased the proportion of participants without intrauterine adhesions at second-look hysteroscopy compared with no intrauterine barrier. In subgroup analyses, the benefit was largely confined to participants undergoing adhesiolysis.