Intrauterine adhesion formation following radiofrequency endometrial ablation with and without a novel intrauterine adhesion barrier film: insights from the CLEAN pilot study.

STUDY

OBJECTIVE

To assess the incidence and severity of adhesions after radiofrequency endometrial ablation when a intrauterine adhesion barrier film was applied.

STUDY

DESIGN

A randomised controlled pilot trial was conducted at two centres in the Netherlands, targeting women aged ≥30 years with refractory heavy menstrual bleeding scheduled for radiofrequency endometrial ablation. Participants were randomised 1:1 to receive either an intrauterine adhesions barrier film (WomedLeaf™, Womed Tech, Montpellier, France) or no barrier film. The primary outcome was the presence and severity of intrauterine adhesions assessed during second-look hysteroscopy (4-6 weeks post-procedure) using the American Fertility Society classification. Secondary outcomes included patient satisfaction and complications, evaluated three months post-procedure.

RESULTS

Intrauterine adhesions were found in 70 % (7/10) of the adhesion barrier film group (median AFS 8, IQR 5.0-8.0) and 81.8 % (9/11) of controls (median AFS 8, IQR 2.0-8.0), with no significant differences. No perforations occurred during barrier insertion, and complication rates were comparable: 3/10 (27.3 %) Clavien-Dindo grade 2 complications in the adhesion barrier film group versus 2/11 (18.2 %) in the control group. Histopathological evaluations of cavity biopsies at second-look hysteroscopy revealed no abnormalities in either group. Patient satisfaction was high in both groups: median scores 8.5 (IQR 7-10) in the adhesion barrier film group, and 9 (IQR 8-10) in the control group (p = 0.717).

CONCLUSION

This study reported a high incidence of intrauterine adhesions after radiofrequency endometrial ablation, with no significant differences in incidence or severity between groups. Despite this, patient satisfaction remained high. Further research is needed to optimise adhesion prevention strategies after radiofrequency endometrial ablation.