Clinical Efficacy Research on the Efficacy and Safety of Hysteroscopic Micro-scissors Combined with a Intrauterine Bigatti Shaver for Treating Moderate to Severe Intrauterine Adhesions

Objective To evaluate the clinical efficacy and safety of hysteroscopic cold micro-scissors combined with an Intrauterine Bigatti Shaver (IBS) for the treatment of moderate to severe intrauterine adhesions (IUA), compared with hysteroscopic adhesiolysis using cold micro-scissors alone. Methods This prospective, single-center, randomized controlled trial enrolled women aged 18–45 years with moderate to severe IUA (AFS score ≥ 5) between January 2023 and June 2025.A total of 133 participants were randomized 1:1 to a Combined Group receiving cold micro-scissors plus a tissue removal IBS (n = 68) or a Control Group receiving cold micro-scissors alone for adhesiolysis (n = 65). All patients received standardized postoperative balloon stenting and sequential estrogen–progestin therapy. The primary endpoint was change in AFS score from baseline to 3 months assessed by blinded hysteroscopists. Secondary outcomes included operative time, blood loss, cavity morphology restoration, menstrual improvement, adhesion recurrence at 6 months, complications, patient satisfaction, and pregnancy outcomes up to 12 months among those desiring fertility. Results All randomized patients completed follow-up. At 3 months, the Combined Group achieved greater AFS score improvement than the Control Group (5.49 ± 1.54 vs 3.91 ± 1.63; P < 0.001; Cohen’s d = 1.00). Operation time was slightly longer in the Combined Group (38.7 ± 10.1 vs 34.8 ± 10.2 min; P = 0.007), while blood loss was significantly lower (median 10.2 vs 22.6 mL; P < 0.001). Menstrual improvement was higher in the Combined Group (90.2% vs 64.8%; P = 0.002), and normal uterine cavity morphology was more frequent (70.6% vs 46.2%; P = 0.034). Overall complications (7.4% vs 29.2%; P = 0.001) and adhesion recurrence at 6 months (7.4% vs 26.2%; P = 0.007) were reduced in the Combined Group. Patient satisfaction was higher (8.0 ± 1.0 vs 7.3 ± 1.2; P < 0.001). Among participants with fertility desire, pregnancy rates at 12 months were 49.0% vs 30.6% (P = 0.099). Conclusions Hysteroscopic micro-scissors combined with an IBS provides superior short-term anatomic restoration and symptom improvement with a lower complication and recurrence profile compared with micro-scissors alone in moderate to severe IUA, with a favorable trend toward improved pregnancy outcomes. These findings support broader adoption and multicenter validation of this endometrium-preserving approach.