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PROSPECT:阴道脱垂手术随机试验的 4 年和 6 年随访。

PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse.

机构信息

Warrell Unit, St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Oxford Road Campus, Manchester, M13 0JH, UK.

Health Services Research Unit, University of Aberdeen, Aberdeen, UK.

出版信息

Int Urogynecol J. 2023 Jan;34(1):67-78. doi: 10.1007/s00192-022-05308-0. Epub 2022 Aug 26.

DOI:10.1007/s00192-022-05308-0
PMID:36018353
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9834125/
Abstract

INTRODUCTION AND HYPOTHESIS

Our aim was to compare the mid-term results of native tissue, biological xenograft and polypropylene mesh surgery for women with vaginal wall prolapse.

METHODS

A total of 1348 women undergoing primary transvaginal repair of an anterior and/or posterior prolapse were recruited between January 2010 and August 2013 from 35 UK centres. They were randomised by remote allocation to native tissue surgery, biological xenograft or polypropylene mesh. We performed both 4- and 6-year follow-up using validated patient-reported outcome measures.

RESULTS

At 4 and 6 years post-operation, there was no clinically important difference in Pelvic Organ Prolapse Symptom Score for any of the treatments. Using a strict composite outcome to assess functional cure at 6 years, we found no difference in cure among the three types of surgery. Half the women were cured at 6 years but only 10.3 to 12% of women had undergone further surgery for prolapse. However, 8.4% of women in the mesh group had undergone further surgery for mesh complications. There was no difference in the incidence of chronic pain or dyspareunia between groups.

CONCLUSIONS

At the mid-term outcome of 6 years, there is no benefit from augmenting primary prolapse repairs with polypropylene mesh inlays or biological xenografts. There was no evidence that polypropylene mesh inlays caused greater pain or dyspareunia than native tissue repairs.

摘要

介绍和假设

我们的目的是比较经阴道修补术治疗女性阴道壁膨出中使用天然组织、生物异种移植物和聚丙烯网片的中期结果。

方法

2010 年 1 月至 2013 年 8 月期间,35 个英国中心共招募了 1348 名接受原发性经阴道前壁和/或后壁膨出修复的女性。通过远程分配,她们被随机分为天然组织手术组、生物异种移植物组或聚丙烯网片组。我们使用经过验证的患者报告结局测量方法进行了 4 年和 6 年的随访。

结果

在术后 4 年和 6 年时,任何一种治疗方法的盆腔器官脱垂症状评分均无临床重要差异。使用严格的复合结局评估 6 年时的功能治愈情况,我们发现三种手术类型之间的治愈率无差异。有一半的女性在 6 年内治愈,但只有 10.3%至 12%的女性因脱垂而接受进一步手术。然而,在网片组中有 8.4%的女性因网片并发症而接受进一步手术。各组间慢性疼痛或性交困难的发生率无差异。

结论

在 6 年的中期结果中,聚丙烯网片嵌片或生物异种移植物对原发性膨出修复没有益处。没有证据表明聚丙烯网片嵌片比天然组织修复引起更大的疼痛或性交困难。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a374/9834125/6635fd5bb7b6/192_2022_5308_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a374/9834125/6635fd5bb7b6/192_2022_5308_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a374/9834125/6635fd5bb7b6/192_2022_5308_Fig1_HTML.jpg

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