To evaluate the efficacy and safety of retaining a balloon stent in the uterus for 8 weeks to prevent adhesion reformation after hysteroscopic adhesiolysis. A single-center randomized controlled study. A total of 160 women with severe intrauterine adhesions (American Fertility Society [AFS] intrauterine adhesion scores ≥9, and European Society for Gynaecological Endoscopy Grade ≥IV). The participants were randomized 1:1 into two groups. In the study group, the balloon stent was left in place for 8 weeks after surgery and removed at the second-look hysteroscopy, with a third-look hysteroscopy performed 4 weeks later. In the control group, the balloon stent was maintained for 1 week, with participants undergoing second- and third-look hysteroscopies at 4 weeks and 8 weeks postoperatively, respectively. Among 160 randomized patients, 136 (69 and 67 in the study and control groups, respectively) completed the study. The primary outcome was the adhesion recurrence rate upon third-look hysteroscopy. On third-look hysteroscopy, the adhesion reformation was significantly lower in the study group than in the control group (17.4% vs. 43.3%; relative risk, 0.40; 95% confidence interval, 0.22-0.72; rate difference, -25.89%; 95% confidence interval, -40.75 to -11.04%). Additionally, the reduction in AFS adhesion scores was significantly larger in the study group than in the control group (10 vs. 7, P<.001). The outcomes of the second- and third-look hysteroscopies were consistent. No safety concerns were observed regarding extended stent placement. In this randomized controlled study, extending the balloon stent application to 8 weeks proved an effective and safe method for preventing adhesion reformation after hysteroscopic adhesiolysis for severe intrauterine adhesions.
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