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.

本研究提出假说：射频子宫内膜消融术（radiofrequency endometrial ablation, EA）后应用可降解聚合物薄膜（WomedLeaf™），可降低宫腔粘连（intrauterine adhesions, IUAs）的形成风险。宫腔粘连是子宫内膜消融术的常见并发症，可引发宫腔积血、消融术后输卵管绝育综合征、逆行性出血及诊断难题。目前已有多种防粘连屏障在宫腔镜手术后预防宫腔粘连中展现出有效性，但针对射频（radiofrequency, RF）这类热消融技术术后的防粘连效果仍尚未明确。

为解答这一问题，本研究于2022年12月至2023年12月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。纳入年龄≥30岁、罹患难治性重度月经过多且符合使用诺舒®（Novasure®）射频系统开展子宫内膜消融术指征的女性患者。所有受试者签署知情同意书并经术中入组资格确认后，按1:1比例随机分配至WomedLeaf™防粘连薄膜组与无屏障对照组。排除标准包括子宫畸形、既往宫腔粘连治疗史、恶性肿瘤、感染性疾病，或对薄膜组分存在已知过敏史。

WomedLeaf™薄膜需在子宫内膜消融术后即刻通过柔性5mm置入器送入宫腔，释放后自行展开以覆盖子宫内膜表面。该薄膜可自然降解，并于一周内排出体外。术中以超声确认其放置位置。所有患者均接受标准化镇静方案与术后镇痛处理。

主要结局指标为宫腔粘连的发生情况与严重程度，于术后4~6周通过二次宫腔镜检查进行评估。该检查于门诊开展，无需麻醉，由盲法观察者操作并记录结果以供外部审核。宫腔粘连采用美国生育学会（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开展组织病理学评估。术后3个月，研究人员通过电话随访受试者，评估月经量（月经失血图pictorial blood loss assessment chart, PBAC）、痛经程度（0~5分量表）、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宫腔粘连的形成机制，以及聚合物防粘连薄膜降低粘连严重程度的潜力提供研究依据，同时为优化子宫内膜消融术后防粘连策略的后续研究提供支持。

搜集汇总

背景与挑战

背景概述

Clean-study数据集是一项关于可降解聚合物薄膜在射频子宫内膜消融后减少宫内粘连形成效果的研究，包含医学领域特别是妇科学相关的数据。数据集发布于2025年4月4日，版本1，DOI为10.17632/b33mj49whx.1。