Mendit装置辅助骶棘韧带固定的短期安全性与手术结局
回顾性单臂队列研究纳入84例接受Mendit锚定装置经阴道骶棘韧带固定(SSLF)的顶端脱垂患者,评估短期安全性与手术结局。经皮入路较传统解剖分离手术时间更短、出血更少。
要点
- Mendit辅助SSLF短期安全性良好,无严重术中损伤或术后严重并发症。
- 最常见不良事件为短暂性尿潴留(23.2%),无需干预可自行缓解。
- 经皮入路较传统阴道解剖分离手术时间更短且出血更少。
核心结论
- 装置辅助骶棘韧带固定表现出良好的短期安全性,并发症和再手术率低。
- 经皮技术可能减少手术时间和组织分离,同时维持临床安全性。
- 该方法为顶端脱垂修复提供了一种有前景的微创自体组织替代方案。
研究设计与样本
- 回顾性单臂队列研究,在三级大学附属泌尿妇科中心开展。
- 纳入2023年1月至2025年6月期间接受Mendit锚定系统经阴道SSLF的84例女性(≥21岁)。
- 干预为经传统阴道解剖分离或经皮无切口技术行锚定装置辅助SSLF,可伴或不伴同期手术。
主要发现
- 平均年龄69.2 ± 11.1岁,平均BMI 26.7 ± 5.6 kg/m²,平均脱垂分期3.6 ± 0.8。
- 双侧固定占67.9%,同期中段尿道吊带置入占40.9%。
- 全手术平均手术时间38.7 ± 14.9分钟,估计失血量31.7 ± 42.2 mL。
- 无术中主要器官损伤或输血,装置故障发生率<1%且无临床后果。
关键数值与推荐
- 装置故障发生率<1%,无临床后果。
- 严重术后并发症(Clavien-Dindo >III)未观察到。
- 短暂性尿潴留发生率23.2%,无需干预自行缓解。
- 经皮入路较传统解剖分离手术时间更短、失血量更少。
临床怎么用
- 装置辅助SSLF可作为顶端脱垂修复的微创自体组织选项,短期安全性可接受。
- 经皮无切口技术可能缩短手术时间并减少组织分离,适合合适患者。
- 术后需关注短暂性尿潴留,但通常无需干预可自行缓解。
局限性
- 回顾性单臂设计,缺乏对照组,无法比较相对疗效。
- 样本量84例,随访时间短,仅评估短期结局。
- 单中心研究,结果外推需谨慎。
以上解读依据论文摘要(全文未开放获取或许可不允许翻译转载)。
原文
STUDY OBJECTIVE: To evaluate short-term safety and operative outcomes of sacrospinous ligament fixation (SSLF) performed using a minimally invasive anchoring device (Mendit) for apical repair. DESIGN: Retrospective single-arm cohort study. SETTING: Tertiary care university-affiliated urogynecology centre. PATIENTS: Women ≥21 years undergoing transvaginal SSLF with the Mendit anchoring system between January 2023 and June 2025 (n = 84). INTERVENTIONS: Apical prolapse repair using anchoring device for SSLF performed via either conventional vaginal dissection or percutaneous incisionless technique, with or without concomitant procedures. MEASUREMENTS AND MAIN RESULTS: Mean age was 69.2 ± 11.1 years and mean BMI 26.7 ± 5.6 kg/m². Most patients had advanced prolapse (mean stage 3.6 ± 0.8). Bilateral fixation was performed in 67.9% of cases and concomitant procedures were common, including mid-urethral sling placement (40.9%). Mean operative time for the full procedure was 38.7 ± 14.9 minutes and estimated blood loss was 31.7 ± 42.2 mL. No intraoperative major organ injuries or transfusions occurred. Device malfunction occurred in <1% without clinical consequence. No serious postoperative complications (Clavien-Dindo >III) were observed. The most common adverse event was transient urinary retention (23.2%), resolving without intervention. Thirty-day reoperation occurred in 3.6% of patients. One urinary tract infection (1.2%) occurred. No early prolapse recurrences were identified. The percutaneous approach demonstrated shorter operative time and lower blood loss compared with conventional dissection. CONCLUSION: Device-assisted sacrospinous ligament fixation demonstrates a favourable short-term safety profile with low complication and reoperation rates. The percutaneous technique may reduce operative time and tissue dissection while maintaining clinical safety. This approach represents a promising minimally invasive native-tissue alternative for apical prolapse repair.
引用
- Hadizadeh A, Chill HH, Leffelman A, et al. Short-term safety and operative outcomes of sacrospinous ligament fixation using the Mendit device. J Minim Invasive Gynecol. 2026. PMID: 42142651. doi:10.1016/j.jmig.2026.05.008
供执业医师工作参考,不替代临床判断;数值与分级以指南原文为准。