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多中心、随机临床试验比较经阴道固有组织和合成网片修补治疗盆腔器官脱垂:5 年随访研究。

A multicenter, randomized trial comparing pelvic organ prolapse surgical treatment with native tissue and synthetic mesh: A 5-year follow-up study.

机构信息

Division of Gynecology, University Hospital, University of Sao Paulo, Sao Paulo, Brazil.

Medical Science University of Holy House of Sao Paulo, Sao Paulo, Brazil.

出版信息

Neurourol Urodyn. 2020 Mar;39(3):1002-1011. doi: 10.1002/nau.24323. Epub 2020 Feb 27.

DOI:10.1002/nau.24323
PMID:32106344
Abstract

INTRODUCTION

The aim of this study was to compare long-term outcomes in patients who underwent either native tissue repair or monofilament macroporous polypropylene mesh.

METHODS

This multicenter, randomized trial included-at the end of 5 years follow-up-122 women with severe pelvic organ prolapse, who were randomly assigned to undergo surgical treatment using native tissue repair (native tissue group, n = 59) or synthetic mesh repair (mesh group, n = 63). Cure criterion was when pelvic organ prolapse-quantification (POP-Q) point was ≤0. Quality of life was assessed using the prolapse quality-of-life questionnaire and sexual function with the quality of sexual function.

RESULTS

Groups were homogeneous preoperatively with the exception of the previous pelvic surgery variable, which was higher in mesh (P = .019). Cure rate was significantly better for mesh group in the anterior compartment (P = .002) and in the combination of all compartments (P = .001). Native tissue group was significantly better when there was prolapse in the posterior and apical compartment (P = .031). In the quality of life analysis, mesh group showed a significant improvement compared with native tissue group (P = .004). Complications were significantly higher in mesh and recurrence in native tissue. Regarding the reoperation rate, there was no difference between groups, but native tissue had a higher reoperation rate due to recurrence (P = .031).

CONCLUSIONS

Outcomes in women with severe POP were better with mesh use than native tissue repair, both in the anterior compartment and in the multicompartmental prolapse after 5-year follow-up. Complications were more common in the mesh group and recurrences were more frequent in the native tissue group.

摘要

介绍

本研究旨在比较接受天然组织修复或单丝大孔聚丙烯网片的患者的长期结局。

方法

这是一项多中心、随机试验,纳入了 122 名患有严重盆腔器官脱垂的女性,在 5 年随访结束时,这些女性被随机分为接受天然组织修复(天然组织组,n=59)或合成网片修复(网片组,n=63)的手术治疗。治愈标准是盆腔器官脱垂量化(POP-Q)点≤0。使用脱垂生活质量问卷评估生活质量,使用性功能质量评估性功能。

结果

两组在术前具有同质性,除了网片组的先前盆腔手术变量较高(P=0.019)。在前后间隔(P=0.002)和所有间隔的组合(P=0.001)中,网片组的治愈率显著更好。当存在后盆腔和顶盆腔脱垂时,天然组织组的疗效显著更好(P=0.031)。在生活质量分析中,网片组与天然组织组相比,有显著改善(P=0.004)。网片组并发症显著高于天然组织组,复发率也更高。关于再次手术率,两组之间无差异,但由于复发,天然组织的再次手术率更高(P=0.031)。

结论

在 5 年随访后,与天然组织修复相比,网片在治疗严重 POP 方面的疗效更好,无论是在前间隔还是多间隔脱垂中。网片组并发症更常见,而天然组织组复发更常见。

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