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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.

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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