Department of Obstetrics and Gynecology, Radboud University Medical Center, Nijmegen, the Netherlands.
Department of Obstetrics and Gynecology, Isala, Zwolle, the Netherlands.
JAMA. 2023 Aug 15;330(7):626-635. doi: 10.1001/jama.2023.13140.
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.
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.
Participants were randomly assigned to undergo sacrospinous hysteropexy (n = 217) or Manchester procedure (n = 217).
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.
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.
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.
TrialRegister.nl Identifier: NTR 6978.
在许多国家，骶骨固定术是进行初次盆腔器官脱垂手术的女性中最常采用的保留子宫技术。然而，骶骨固定术与较老的技术（曼彻斯特手术）在治疗子宫脱垂的效果方面尚无直接比较。
比较骶骨固定术与曼彻斯特手术治疗子宫下垂的效果。
设计、地点和参与者：这项多中心、非劣效性随机临床试验在荷兰 26 家医院进行，纳入了 434 名初次接受子宫下垂手术治疗但子宫未脱垂至处女膜以外的成年患者。
参与者被随机分配至接受骶骨固定术（n=217）或曼彻斯特手术（n=217）。
主要结局是复合结局，定义为采用标准化阴道支撑量化系统评估的任何部位均无盆腔器官脱垂超出处女膜、无明显膨出症状、且术后 2 年内无需再次行子宫脱垂治疗（子宫托或手术）。预设的非劣效性边界为 9%。次要结局包括解剖学和患者报告结局、围手术期参数以及与手术相关的并发症。
在纳入意向治疗分析的 393 名参与者中（平均年龄 61.7 岁[SD，9.1 岁]），骶骨固定术组有 151 名（77.0%）和曼彻斯特手术组有 172 名（87.3%）达到了复合结局的成功标准。骶骨固定术未满足下限置信区间（CI）差值-9%的非劣效性标准（风险差异-10.3%；95%CI，-17.8%至-2.8%；P=.63 用于非劣效性检验）。在 2 年随访时，两组的围手术期结局和患者报告结局无差异。
基于初次行保留子宫的盆腔器官脱垂手术治疗子宫脱垂 2 年后的手术成功综合结局，这些结果支持这样一种发现，即骶骨固定术逊于曼彻斯特手术。
TrialRegister.nl 标识符：NTR 6978。
