Background

Laparoscopic mesh sacropexy (LS) or transvaginal mesh repair (TVM) are surgical techniques used to treat cystoceles. Health authorities have highlighted the need for comparative studies to evaluate the safety of surgeries with meshes.

Objective

To compare the rate of complications, and functional and anatomical outcomes between LS and TVM.

Design, setting, and participants

Multicenter randomized controlled trial from October 2012 to April 2014 in 11 French public hospitals. Women with cystocele stage ≥2 (pelvic organ prolapse quantification), aged 45–75 yr, without previous prolapse surgery.

Intervention

Synthetic nonabsorbable mesh placed in the vesicovaginal space, sutured to the promontory (LS) or maintained by arms through pelvic ligaments (TVM).

Outcome measurements and statistical analysis

Rate of surgical complications ≥grade II according to the modified Clavien–Dindo classification at 1 yr. Secondary outcomes were reintervention rate, and functional and anatomical results.

Results and limitations

A total of 130 women were randomized in LS and 132 in TVM; five women withdrew before intervention, leaving 129 in LS and 128 in TVM. The rate of complications ≥grade II was lower after LS than after TVM, but did not meet statistical significance (17% vs 26%, treatment difference 8.6% [95% confidence interval, CI −1.5 to 18]; p = 0.088). The rate of complications of grade III or higher was nonetheless significantly lower after LS (LS = 0.8%, TVM = 9.4%, treatment difference 8.6% [95% CI 3.4%; 15%]; p = 0.001). LS was converted to TVM in 6.3%. The total reoperation rate was lower after LS but did not meet statistical significance (LS = 4.7%, TVM = 10.9%, treatment difference 6.3% [95% CI −0.4 to 13.3]; p = 0.060). There was no difference in symptoms, quality of life, improvement, composite definition of success, anatomical results rates between groups except for the vaginal apex and length, and dyspareunia (in favor of LS).

Conclusions

LS is a valuable option for primary repair of cystocele in sexually active patients. LS is safer than TVM, but may not be feasible in all cases. Both techniques offer same functional outcomes, success rates, and anatomical outcomes, but sexual function is better preserved by LS.

Patient summary

Our study demonstrates that laparoscopic sacropexy (LS) is a valuable option for primary repair of cystocele. LS offers equivalent success rates to vaginal mesh procedures, but is safer with a lower rate of complications and reoperations, and sexual function is better preserved.

中文翻译：

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阴道网手术与腹腔镜网囊切除术对膀胱膨出术的安全性：盆腔假体修复的结果随机对照试验

背景

腹腔镜网状囊切除术（LS）或经阴道网状修复术（TVM）是用于治疗膀胱膨出的外科手术技术。卫生当局强调需要进行比较研究以评估带网眼手术的安全性。

客观的

比较LS和TVM之间的并发症发生率以及功能和解剖结局。

设计，设置和参与者

2012年10月至2014年4月在法国11家公立医院进行的多中心随机对照试验。膀胱膨大阶段≥2（盆腔器官脱垂量化）的女性，年龄45-75岁，未接受过脱垂手术。

干涉

合成的不可吸收网布放置在膀胱阴道空间中，缝合到海角（LS）或由手臂通过骨盆韧带（TVM）进行维护。

成果测量和统计分析

根据改良的Clavien-Dindo分类法，在1年时，手术并发症的发生率≥II级。次要结果是再干预率以及功能和解剖学结果。

结果与局限性

共有130名妇女在LS中被随机分配，而132名在TVM中被随机分配。五名妇女在干预前退出，在LS中留下129名，在TVM中留下128名。LS后≥II级并发症的发生率低于TVM后，但未达到统计学显着性（17％vs 26％，治疗差异8.6％[95％置信区间，CI -1.5至18]；p  = 0.088）。LS后，III级或更高级别的并发症发生率显着降低（LS = 0.8％，TVM = 9.4％，治疗差异8.6％[95％CI 3.4％; 15％]；p  = 0.001）。LS转换为TVM的比例为6.3％。LS后的总再手术率较低，但未达到统计学显着性（LS = 4.7％，TVM = 10.9％，治疗差异6.3％[95％CI -0.4至13.3]；p = 0.060）。两组之间的症状，生活质量，改善，成功的综合定义，解剖学上的结果率无差异，除了阴道的根尖和长度，以及性交困难（赞成LS）。

结论

LS是对性活跃患者进行膀胱膨出术的初步修复的重要选择。LS比TVM更安全，但并非在所有情况下都可行。两种技术均提供相同的功能结局，成功率和解剖结局，但LS可以更好地保留性功能。

病人总结

我们的研究表明，腹腔镜食管切除术（LS）是膀胱囊肿一次修复的有价值的选择。LS可提供与阴道网状手术相当的成功率，但更安全，并发症和再次手术的发生率也更低，并且性功能得到更好的保护。