VIGI-MESH注册研究中2309名女性盆腔器官脱垂手术后的严重并发症及复发情况。

Serious complications and recurrences after pelvic organ prolapse surgery for 2309 women in the VIGI-MESH registry.

作者信息

Fritel X, de Tayrac R, de Keizer J, Campagne-Loiseau S, Cosson M, Ferry P, Deffieux X, Lucot J-P, Wagner L, Debodinance P, Saussine C, Pizzoferrato A-C, Carlier-Guérin C, Thubert T, Panel L, Bosset P-O, Nkounkou E, Ramanah R, Boisramé T, Charles T, Raiffort C, Charvériat A, Ragot S, Fauconnier A

机构信息

Service de Gynécologie, CHU de Poitiers, Poitiers, France.

Université de Poitiers, INSERM CIC 1402, Poitiers, France.

出版信息

BJOG. 2022 Mar;129(4):656-663. doi: 10.1111/1471-0528.16892. Epub 2021 Sep 20.

DOI:10.1111/1471-0528.16892

PMID:34541781

Abstract

OBJECTIVE

To assess the incidence of serious complications and reoperations for recurrence after surgery for pelvic organ prolapse (POP) and compare the three most common types of repair.

DESIGN

Prospective cohort study using a registry.

SETTING

Nineteen French surgical centres.

POPULATION

A total of 2309 women participated between 2017 and 2019.

METHODS

A multivariate analysis including an inverse probability of treatment weighting approach was used to obtain three comparable groups.

MAIN OUTCOME MEASURES

Serious complications and subsequent reoperations for POP recurrence.

RESULTS

The median follow-up time was 17.6 months. Surgeries were native tissue vaginal repairs (n = 504), transvaginal mesh placements (n = 692) and laparoscopic sacropexies with mesh (n = 1113). Serious complications occurred among 52 women (2.3%), and reoperation for POP recurrence was required for 32 women (1.4%). At 1 year the cumulative weighted incidence of serious complications was 1.8% for native tissue vaginal repair, 3.9% for transvaginal mesh and 2.2% for sacropexy, and the rates for reoperation for recurrence of POP were 1.5, 0.7 and 1.1%, respectively. Compared with native tissue vaginal repair, the risk of serious complications was higher in the transvaginal mesh group (weighted hazard ratio, wHR 3.84, 95% CI 2.43-6.08) and the sacropexy group (wHR 2.48, 95% CI 1.45-4.23), whereas the risk of reoperation for prolapse recurrence was lower in both the transvaginal mesh (wHR 0.22, 95% CI 0.13-0.39) and sacropexy (wHR 0.29, 95% CI 0.18-0.47) groups.

CONCLUSIONS

Our results suggest that native tissue vaginal repairs have the lowest risk of serious complications but the highest risk of reoperation for recurrence. These results are useful for informing women and for shared decision making.

TWEETABLE ABSTRACT

Laparoscopic sacropexy had fewer serious complications than transvaginal mesh and fewer reoperations for recurrence than vaginal repair.

摘要

目的

评估盆腔器官脱垂（POP）手术后严重并发症的发生率以及复发后的再次手术情况，并比较三种最常见的修复方式。

设计

使用登记系统的前瞻性队列研究。

地点

19个法国外科中心。

研究对象

2017年至2019年间共有2309名女性参与。

方法

采用多变量分析，包括治疗权重逆概率法，以获得三个可比组。

主要观察指标

严重并发症及POP复发后的再次手术。

结果

中位随访时间为17.6个月。手术方式包括自体组织阴道修复（n = 504）、经阴道网片植入（n = 692）和腹腔镜骶骨固定术加网片（n = 1113）。52名女性（2.3%）发生了严重并发症，32名女性（1.4%）因POP复发需要再次手术。1年时，自体组织阴道修复严重并发症的累积加权发生率为1.8%，经阴道网片为3.9%，骶骨固定术为2.2%；POP复发再次手术的发生率分别为1.5%、0.7%和1.1%。与自体组织阴道修复相比，经阴道网片组严重并发症的风险更高（加权风险比，wHR 3.84，95%CI 2.43 - 6.08），骶骨固定术组也是如此（wHR 2.48，95%CI 1.45 - 4.23）；而经阴道网片组（wHR 0.22，95%CI 0.13 - 0.39）和骶骨固定术组（wHR 0.29，95%CI 0.18 - 0.47）脱垂复发再次手术的风险较低。