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经阴道合成网片用于阴道前壁脱垂修复的随机对照试验。

The use of transvaginal synthetic mesh for anterior vaginal wall prolapse repair: a randomized controlled trial.

作者信息

Delroy Carlos A, Castro Rodrigo de A, Dias Márcia M, Feldner Paulo C, Bortolini Maria Augusta T, Girão Manoel J B C, Sartori Marair G F

机构信息

Sector of Urogynecology and Vaginal Surgery, Department of Gynecology, Federal University of São Paulo, Rua Joaquim Floriano, 871 cj 92, São Paulo, SP, Brazil, 04534-000,

出版信息

Int Urogynecol J. 2013 Nov;24(11):1899-907. doi: 10.1007/s00192-013-2092-0. Epub 2013 Apr 30.

Abstract

INTRODUCTION AND HYPOTHESIS

The aim of the study was to compare the efficacy and safety of transvaginal trocar-guided polypropylene mesh insertion with traditional colporrhaphy for treatment of anterior vaginal wall prolapse.

METHODS

This is a randomized controlled trial in which women with advanced anterior vaginal wall prolapse, at least stage II with Ba ≥ +1 cm according to the Pelvic Organ Prolapse Quantification (POP-Q) classification, were randomly assigned to have either anterior colporrhaphy (n = 39) or repair using trocar-guided transvaginal mesh (n = 40). The primary outcome was objective cure rate of the anterior compartment (point Ba) assessed at the 12-month follow-up visit, with stages 0 and I defined as anatomical success. Secondary outcomes included quantification of other vaginal compartments (POP-Q points), comparison of quality of life by the prolapse quality of life (P-QOL) questionnaire, and complication rate between the groups after 1 year. Study power was fixed as 80% with 5% cutoff point (p < 0.05) for statistical significance.

RESULTS

The groups were similar regarding demographic and clinical preoperative parameters. Anatomical success rates for colporrhaphy and repair with mesh placement groups were 56.4 vs 82.5% (95% confidence interval 0.068-0.54), respectively, and the difference between the groups was statistically significant (p = 0.018). Similar total complication rates were observed in both groups, with tape exposure observed in 5% of the patients. There was a significant improvement in all P-QOL domains as a result of both procedures (p < 0.001), but they were not distinct between groups (p > 0.05).

CONCLUSIONS

Trocar-guided transvaginal synthetic mesh for advanced anterior POP repair is associated with a higher anatomical success rate for the anterior compartment compared with traditional colporrhaphy. Quality of life equally improved after both techniques. However, the trial failed to detect differences in P-QOL scores and complication rates between the groups.

摘要

引言与假设

本研究旨在比较经阴道套管针引导聚丙烯网片植入术与传统阴道修补术治疗阴道前壁脱垂的疗效和安全性。

方法

这是一项随机对照试验,将盆腔器官脱垂定量(POP-Q)分类中至少为II期且Ba≥+1cm的重度阴道前壁脱垂女性随机分为两组,分别接受阴道前壁修补术(n = 39)或套管针引导经阴道网片修补术(n = 40)。主要结局是在12个月随访时评估前盆腔(Ba点)的客观治愈率,0期和I期定义为解剖学成功。次要结局包括其他阴道腔室的定量(POP-Q点)、通过脱垂生活质量(P-QOL)问卷比较生活质量,以及1年后两组之间的并发症发生率。研究效能设定为80%,统计学显著性的截断点为5%(p < 0.05)。

结果

两组在人口统计学和术前临床参数方面相似。阴道修补术组和网片植入修补术组的解剖学成功率分别为56.4%和82.5%(95%置信区间0.068 - 0.54),两组之间的差异具有统计学显著性(p = 0.018)。两组观察到的总并发症发生率相似,5% 的患者出现网带暴露。两种手术均使所有P-QOL领域有显著改善(p < 0.001),但两组之间无明显差异(p > 0.05)。

结论

与传统阴道修补术相比,套管针引导经阴道合成网片用于重度阴道前壁脱垂修补术可使前盆腔获得更高的解剖学成功率。两种技术术后生活质量均得到同等改善。然而,该试验未能检测到两组之间P-QOL评分和并发症发生率的差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d63f/3824218/07d93ab291ae/192_2013_2092_Fig1_HTML.jpg

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