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期刊来源：JAMA

文献发表时间：2023.08.15

原文链接：https://jamanetwork.com/journals/jama/article-abstract/2808326

关键点内容如下：

问题

在治疗不超过处女膜的子宫下垂时，阴道骶骨固定术是否不劣于曼彻斯特手术？

调查结果

这项非劣效性随机临床试验纳入了434名子宫下垂但未突出处女膜的患者。与曼彻斯特手术相比，阴道骶骨固定术2年后成功的复合结局较低（即不符合非劣效性标准）。

意义

在子宫下垂但未突出处女膜的患者中，与Manchester手术相比，阴道骶骨固定术的2年综合预后较低，这与其劣势一致。

摘要内容如下：

重要性

在许多国家，阴道骶骨固定术是首次接受盆腔器官脱垂手术的妇女最常用的保留子宫的技术。然而，阴道骶骨固定术与较老的曼彻斯特手术的结果没有直接的比较。

目标

比较阴道骶骨固定术与曼彻斯特手术治疗子宫下垂的成功率。

研究设计和参与者

在荷兰26家医院进行的多中心、非劣效性随机临床试验中，434名成年患者接受了首次子宫下垂手术治疗，该手术未超出处女膜。

干预

参与者被随机分配接受阴道骶骨固定术（n=217）或曼彻斯特手术（n=217）。

主要结果和措施

主要结局，定义为通过标准化阴道支持量化系统评估，在任何隔室中没有超过处女膜的盆腔器官脱垂，没有令人烦恼的隆起症状，并且在手术后2年内没有脱垂再治疗（子宫托或手术）。预定义的非劣效性界值为9%。次要结果是解剖和患者报告的结果、围手术期参数和手术相关并发症。

次要结果

随机分析的393名参与者（平均年龄61.7岁[SD，9.1岁]）中，阴道骶骨固定术组196人中的151人（77.0%）和曼彻斯特手术组197人中的172人（87.3%）获得了成功的复合结果。阴道骶骨固定术不符合非劣效性标准，CI（风险差异的下限为-9%，-10.3%；95%置信区间，-17.8%至-2.8%；非劣效性）P=0.63。在2年的随访中，两组的围手术期结果和患者报告的结果没有差异。

结论和相关性

基于初次保留子宫的盆腔器官脱垂手术治疗子宫下垂后2年手术成功的综合结局，这些结果支持阴道骶骨固定术不如曼彻斯特手术的发现。

英文原文如下：

Key Points

Question  Is sacrospinous hysteropexy noninferior to the Manchester procedure for treatment of uterine descent that is not beyond the hymen?

Findings  This noninferiority randomized clinical trial included 434 patients with uterine descent that did not protrude beyond the hymen. The composite outcome of success after 2 years was lower for sacrospinous hysteropexy compared with the Manchester procedure (ie, did not meet noninferiority criteria).

Meaning  In patients with uterine descent that did not protrude beyond the hymen, the lower composite 2-year outcomes are consistent with inferiority of sacrospinous hysteropexy compared with the Manchester procedure.

Abstract

Importance  In many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse. However, there are no direct comparisons of outcomes after sacrospinous hysteropexy vs an older technique, the Manchester procedure.

Objective  To compare success of sacrospinous hysteropexy vs the Manchester procedure for the surgical treatment of uterine descent.

Design, Setting, and Participants  Multicenter, noninferiority randomized clinical trial conducted in 26 hospitals in the Netherlands among 434 adult patients undergoing a first surgical treatment for uterine descent that did not protrude beyond the hymen.

Interventions  Participants were randomly assigned to undergo sacrospinous hysteropexy (n = 217) or Manchester procedure (n = 217).

Main Outcomes and Measures  The primary outcome was a composite outcome of success, defined as absence of pelvic organ prolapse beyond the hymen in any compartment evaluated by a standardized vaginal support quantification system, absence of bothersome bulge symptoms, and absence of prolapse retreatment (pessary or surgery) within 2 years after the operation. The predefined noninferiority margin was 9%. Secondary outcomes were anatomical and patient-reported outcomes, perioperative parameters, and surgery-related complications.

Results  Among 393 participants included in the as-randomized analysis (mean age, 61.7 years [SD, 9.1 years]), 151 of 196 (77.0%) in the sacrospinous hysteropexy group and 172 of 197 (87.3%) in the Manchester procedure group achieved the composite outcome of success. Sacrospinous hysteropexy did not meet the noninferiority criterion of −9% for the lower limit of the CI (risk difference, −10.3%; 95% CI, −17.8% to −2.8%; P = .63 for noninferiority). At 2-year follow-up, perioperative outcomes and patient-reported outcomes did not differ between the 2 groups.

Conclusions  Based on the composite outcome of surgical success 2 years after primary uterus-sparing pelvic organ prolapse surgery for uterine descent, these results support a finding that sacrospinous hysteropexy is inferior to the Manchester procedure.