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用于阴道盆腔器官脱垂手术的部分可吸收网片(SERATOM PA)是一种安全有效的选择:一项多中心前瞻性研究。

Partially Absorbable Mesh (SERATOM PA) for Vaginal Pelvic Organ Prolapse Surgery is a Safe and Effective Option: A Multi-Center and Prospective Study.

作者信息

Lee Sa Ra, Shin Jung Ho, Chae Hee Dong

机构信息

Department of Obstetrics and Gynecology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.

Department of Obstetrics and Gynecology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.

出版信息

J Menopausal Med. 2025 Aug;31(2):102-109. doi: 10.6118/jmm.24010.

DOI:10.6118/jmm.24010
PMID:40954994
Abstract

OBJECTIVES

This prospective multi-center pilot study evaluated the safety, efficacy, and quality of life (QoL) outcomes associated with the use of a transvaginal mesh kit utilizing partially absorbable mesh (PAM) in Korean women with pelvic organ prolapse (POP).

METHODS

Thirty patients with symptomatic POP stage II or higher underwent surgical repair using the SERATOM PA mesh between March 2013 and February 2015. The primary endpoint was the objective surgical success rate, assessed by POP-Q stage and the need for repeat surgery within six months postoperatively. Secondary endpoints included QoL assessment using validated questionnaires (King's Health Questionnaire, PFDI-20, PFIQ-7, and PISQ-12) and monitoring of complications.

RESULTS

The mean participant age was 65.6 years, with 97% being postmenopausal. Preoperative POP-Q staging revealed that most patients (87%) had stage III or IV prolapse. The average surgical time was 96.4 minutes, and hospital stay averaged 4.9 days. No intraoperative or postoperative complications were reported. Of the 24 patients who completed follow-up, 23 achieved POP-Q stage 0 at six months, with the remaining patient at stage I but asymptomatic, requiring no further intervention. No cases of healing abnormalities or reoperations were noted. Significant improvements in pelvic floor dysfunction symptoms and sexual function were observed, as evidenced by marked improvements in PFDI-20, PFIQ-7, and PISQ-12 scores at six months postoperatively.

CONCLUSIONS

The use of PAM in transvaginal POP surgery demonstrated high efficacy, excellent safety outcomes, and significant improvement in QoL, suggesting it is a viable surgical option for advanced POP in this patient population.

摘要

目的

本前瞻性多中心试点研究评估了在韩国盆腔器官脱垂(POP)女性中使用部分可吸收网片(PAM)经阴道网片套件相关的安全性、有效性和生活质量(QoL)结果。

方法

2013年3月至2015年2月期间,30例有症状的II期或更高分期POP患者接受了使用SERATOM PA网片的手术修复。主要终点是客观手术成功率,通过POP-Q分期和术后六个月内再次手术的需求进行评估。次要终点包括使用经过验证的问卷(国王健康问卷、PFDI-20、PFIQ-7和PISQ-12)进行QoL评估以及并发症监测。

结果

参与者的平均年龄为65.6岁,97%为绝经后女性。术前POP-Q分期显示,大多数患者(87%)为III期或IV期脱垂。平均手术时间为96.4分钟,平均住院时间为4.9天。未报告术中或术后并发症。在完成随访的24例患者中,23例在六个月时达到POP-Q 0期,其余患者为I期但无症状,无需进一步干预。未发现愈合异常或再次手术的病例。术后六个月时,PFDI-20、PFIQ-7和PISQ-12评分显著改善,表明盆底功能障碍症状和性功能有显著改善。

结论

在经阴道POP手术中使用PAM显示出高疗效、出色的安全性结果以及QoL的显著改善,表明它是该患者群体中晚期POP的可行手术选择。

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本文引用的文献

1
Depression symptoms in women with pelvic floor dysfunction: a case-control study.盆底功能障碍女性的抑郁症状:一项病例对照研究。
Int J Womens Health. 2019 Feb 22;11:143-148. doi: 10.2147/IJWH.S187417. eCollection 2019.
2
What Impacts the All Cause Risk of Reoperation after Pelvic Organ Prolapse Repair? A Comparison of Mesh and Native Tissue Approaches in 110,329 Women.什么因素影响盆腔器官脱垂修复术后的全因再手术风险?110329 名女性中网片与天然组织修补方法的比较。
J Urol. 2018 Aug;200(2):389-396. doi: 10.1016/j.juro.2018.02.3093. Epub 2018 Mar 3.
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Polypropylene Mesh Predicts Mesh/Suture Exposure After Sacrocolpopexy Independent of Known Risk Factors: A Retrospective Case-Control Study.
聚丙烯网片可独立于已知风险因素预测骶骨阴道固定术后网片/缝线暴露:一项回顾性病例对照研究。
Female Pelvic Med Reconstr Surg. 2018 Sep/Oct;24(5):360-366. doi: 10.1097/SPV.0000000000000452.
4
Adverse events after first, single, mesh and non-mesh surgical procedures for stress urinary incontinence and pelvic organ prolapse in Scotland, 1997-2016: a population-based cohort study.1997-2016 年苏格兰首次、单次、网片和非网片手术治疗压力性尿失禁和盆腔器官脱垂的不良事件:一项基于人群的队列研究。
Lancet. 2017 Feb 11;389(10069):629-640. doi: 10.1016/S0140-6736(16)32572-7. Epub 2016 Dec 21.
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Surgery for women with anterior compartment prolapse.前盆腔脏器脱垂女性的手术治疗
Cochrane Database Syst Rev. 2016 Nov 30;11(11):CD004014. doi: 10.1002/14651858.CD004014.pub6.
6
Graft and Mesh Use in Transvaginal Prolapse Repair: A Systematic Review.阴道脱垂修复术中移植物和补片的应用:一项系统评价
Obstet Gynecol. 2016 Jul;128(1):81-91. doi: 10.1097/AOG.0000000000001451.
7
Surgeon Experience and Complications of Transvaginal Prolapse Mesh.外科医生经验与经阴道脱垂补片的并发症
Obstet Gynecol. 2016 Jul;128(1):65-72. doi: 10.1097/AOG.0000000000001450.
8
Efficacy and safety of skeletonized mesh implants for advanced pelvic organ prolapse: 12-month follow-up.用于晚期盆腔器官脱垂的骨骼化网状植入物的疗效和安全性:12个月随访
World J Urol. 2016 Oct;34(10):1491-8. doi: 10.1007/s00345-016-1792-8. Epub 2016 Feb 23.
9
Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse.经阴道网状物或移植物与阴道脱垂的自体组织修复的比较。
Cochrane Database Syst Rev. 2016 Feb 9;2(2):CD012079. doi: 10.1002/14651858.CD012079.
10
Risk factors for pelvic organ prolapse and its recurrence: a systematic review.盆腔器官脱垂及其复发的危险因素:一项系统综述。
Int Urogynecol J. 2015 Nov;26(11):1559-73. doi: 10.1007/s00192-015-2695-8. Epub 2015 May 13.