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36个月随访时,用于膀胱膨出矫正的异体网片植入的生活质量、性功能、解剖学结果及副作用

Quality of Life, Sexuality, Anatomical Results and Side-effects of Implantation of an Alloplastic Mesh for Cystocele Correction at Follow-up after 36 Months.

作者信息

Fünfgeld Christian, Stehle Margit, Henne Brigit, Kaufhold Jan, Watermann Dirk, Grebe Markus, Mengel Mathias

机构信息

Klinik Tettnang GmbH, Tettnang, Germany.

St. Elisabeth Krankenhaus, Leipzig, Germany.

出版信息

Geburtshilfe Frauenheilkd. 2017 Sep;77(9):993-1001. doi: 10.1055/s-0043-116857. Epub 2017 Sep 25.

Abstract

INTRODUCTION

Pelvic organ prolapse can significantly reduce quality of life of affected women, with many cases requiring corrective surgery. The rate of recurrence is relatively high after conventional prolapse surgery. In recent years, alloplastic meshes have increasingly been implanted to stabilize the pelvic floor, which has led to considerable improvement of anatomical results. But the potential for mesh-induced risks has led to a controversial discussion on the use of surgical meshes in urogynecology. The impact of cystocele correction and implantation of an alloplastic mesh on patients' quality of life/sexuality and the long-term stability of this approach were investigated.

METHOD

In a large prospective multicenter study, 289 patients with symptomatic cystocele underwent surgery with implantation of a titanized polypropylene mesh (TiLOOP Total 6, pfm medical ag) and followed up for 36 months. Both primary procedures and procedures for recurrence were included in the study. Anatomical outcomes were quantified using the POP-Q system. Quality of life including sexuality were assessed using the German version of the validated P-QoL questionnaire. All adverse events were assessed by an independent clinical event committee.

RESULTS

Mean patient age was 67 ± 8 years. Quality of life improved significantly over the course of the study in all investigated areas, including sexuality and personal relationships (p < 0.001, Wilcoxon test). The number of adverse events which occurred in the period between 12 and 36 months after surgery was low, with just 22 events reported. The recurrence rate for the anterior compartment was 4.5%. Previous or concomitant hysterectomy increased the risk of recurrence in the posterior compartment 2.8-fold and increased the risk of erosion 2.25-fold.

CONCLUSION

Cystocele correction using a 2nd generation alloplastic mesh achieved good anatomical and functional results in cases requiring stabilization of the pelvic floor and in patients with recurrence. The rate of recurrence was low, the patients' quality of life improved significantly, and the risks were acceptable.

摘要

引言

盆腔器官脱垂会显著降低受影响女性的生活质量,许多病例需要进行矫正手术。传统脱垂手术后复发率相对较高。近年来,越来越多地植入异体网片来稳定盆底,这在解剖学结果方面带来了显著改善。但网片引发风险的可能性引发了泌尿妇科手术网片使用方面的争议性讨论。研究了膀胱膨出矫正和异体网片植入对患者生活质量/性功能的影响以及该方法的长期稳定性。

方法

在一项大型前瞻性多中心研究中,289例有症状的膀胱膨出患者接受了植入钛化聚丙烯网片(TiLOOP Total 6,pfm medical ag)的手术,并随访36个月。研究纳入了初次手术和复发手术。使用POP-Q系统对解剖学结果进行量化。使用经过验证的P-QoL问卷德语版评估包括性功能在内的生活质量。所有不良事件均由独立临床事件委员会进行评估。

结果

患者平均年龄为67±8岁。在研究过程中,所有调查领域,包括性功能和人际关系方面,生活质量均有显著改善(p<0.001,Wilcoxon检验)。术后12至36个月期间发生的不良事件数量较少,仅报告了22起事件报告。前盆腔复发率为4.5%。既往或同时进行子宫切除术使后盆腔复发风险增加2.8倍,侵蚀风险增加2.25倍。

结论

使用第二代异体网片进行膀胱膨出矫正,在需要稳定盆底的病例和复发患者中取得了良好的解剖学和功能结果。复发率低,患者生活质量显著改善,风险可接受。

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