Clean-study

This study hypothesized that the use of a degradable polymer film (WomedLeaf™) following radiofrequency endometrial ablation (EA) could reduce the formation of intrauterine adhesions (IUAs). IUAs are a common complication of EA and may lead to hematometra, post-ablation tubal sterilization syndrome, retrograde bleeding, and diagnostic challenges. While several anti-adhesion barriers have shown efficacy in preventing IUAs after hysteroscopic surgery, their effectiveness following thermal ablation techniques like radiofrequency (RF) remains unknown.

We conducted a multicenter, randomized, controlled, and blinded pilot trial at two Dutch hospitals between December 2022 and December 2023 to address this. Women aged ≥30 years with refractory heavy menstrual bleeding, eligible for EA with the Novasure® RF system, were included. After consent and intraoperative eligibility confirmation, participants were randomized 1:1 to either receive the WomedLeaf™ adhesion barrier film or no barrier. Exclusion criteria included uterine anomalies, prior IUA treatment, malignancies, infections, or known allergies to the film’s components.

The WomedLeaf™ film was inserted immediately following EA using a flexible 5-mm inserter and released intrauterine, unfolding to cover the endometrial surface. The film naturally degrades and is discharged within one week. Ultrasound was used to confirm positioning. All patients received standardized sedation and postoperative analgesia.

The primary outcome was IUA presence and severity, assessed via second-look hysteroscopy 4–6 weeks post-procedure. These were performed outpatient, without anaesthesia, by a blinded observer and recorded for external review. IUAs were categorized using the American Fertility Society (AFS) classification. Endometrial biopsies were obtained during the procedure for histopathological evaluation. After 3 months, participants were contacted by phone to assess bleeding (PBAC), dysmenorrhea (0–5 scale), satisfaction (0–5 scale), and adverse events.

These data provide insight into IUA formation after RF ablation and the potential of a polymer barrier film to reduce adhesion severity. They support future research on optimizing adhesion prevention strategies in endometrial ablation.

本研究假设，在射频子宫内膜消融术（radiofrequency endometrial ablation, EA）后使用可降解聚合物薄膜（WomedLeaf™），可降低宫内粘连（intrauterine adhesions, IUAs）的形成。IUAs是EA的常见并发症，可能引发宫腔积血、消融术后输卵管绝育综合征、逆行性出血及诊断难题。目前已有多款防粘连屏障在宫腔镜手术后预防IUAs方面展现出疗效，但针对射频（radiofrequency, RF）这类热消融技术术后的预防效果仍不明确。

为解答这一研究空白，本研究于2022年12月至2023年12月间在荷兰两家医院开展了一项多中心、随机、对照、盲法先导试验。纳入对象为年龄≥30岁、符合诺舒®（Novasure®）射频系统适应证、可接受EA治疗的难治性月经过多女性。在获取知情同意并确认术中符合入组标准后，受试者按1:1比例随机分为两组，分别接受WomedLeaf™防粘连薄膜或不使用任何防粘连屏障材料。排除标准包括子宫畸形、既往IUA治疗史、恶性肿瘤、感染或已知对薄膜成分过敏者。

WomedLeaf™薄膜于EA术后即刻通过柔性5mm置入器送入宫腔，释放后可自行展开覆盖子宫内膜表面。该薄膜可自然降解并于一周内排出体外，术中通过超声确认其放置位置。所有受试者均接受标准化镇静方案及术后镇痛处理。

本研究的主要结局指标为术后4~6周通过二次宫腔镜检查评估的IUAs发生情况及严重程度。该检查于门诊无麻醉条件下开展，由盲法观察者完成操作并记录结果以供外部评审。IUAs采用美国生殖医学会（American Fertility Society, AFS）分类标准进行分级。术中同时采集子宫内膜活检标本以进行组织病理学评估。术后3个月，研究人员通过电话随访受试者，评估其月经失血量（PBAC）、痛经程度（0~5分量表）、治疗满意度（0~5分量表）及不良事件发生情况。

本数据集可为射频消融术后IUAs的形成特征以及聚合物薄膜降低粘连严重程度的潜在作用提供研究参考，同时可为优化子宫内膜消融术中粘连预防策略的后续研究提供支持。