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Effect of Vaginal Mesh Hysteropexy vs Vaginal Hysterectomy With Uterosacral Ligament Suspension on Treatment Failure in Women With Uterovaginal Prolapse
JAMA ( IF 63.1 ) Pub Date : 2019-09-17 , DOI: 10.1001/jama.2019.12812 Charles W Nager 1 , Anthony G Visco 2 , Holly E Richter 3 , Charles R Rardin 4 , Rebecca G Rogers 5, 6 , Heidi S Harvie 7 , Halina M Zyczynski 8 , Marie Fidela R Paraiso 9 , Donna Mazloomdoost 10 , Scott Grey 11 , Amaanti Sridhar 11 , Dennis Wallace 11 ,
JAMA ( IF 63.1 ) Pub Date : 2019-09-17 , DOI: 10.1001/jama.2019.12812 Charles W Nager 1 , Anthony G Visco 2 , Holly E Richter 3 , Charles R Rardin 4 , Rebecca G Rogers 5, 6 , Heidi S Harvie 7 , Halina M Zyczynski 8 , Marie Fidela R Paraiso 9 , Donna Mazloomdoost 10 , Scott Grey 11 , Amaanti Sridhar 11 , Dennis Wallace 11 ,
Affiliation
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Importance
Vaginal hysterectomy with suture apical suspension is commonly performed for uterovaginal prolapse. Transvaginal mesh hysteropexy is an alternative option. Objective
To compare the efficacy and adverse events of vaginal hysterectomy with suture apical suspension and transvaginal mesh hysteropexy. Design, Setting, Participants
At 9 clinical sites in the US Pelvic Floor Disorders Network, 183 postmenopausal women with symptomatic uterovaginal prolapse were enrolled in a randomized superiority clinical trial between April 2013 and February 2015. The study was designed for primary analysis when the last randomized participant reached 3 years of follow-up in February 2018. Interventions
Ninety-three women were randomized to undergo vaginal mesh hysteropexy and 90 were randomized to undergo vaginal hysterectomy with uterosacral ligament suspension. Main Outcomes and Measures
The primary treatment failure composite outcome (re-treatment of prolapse, prolapse beyond the hymen, or prolapse symptoms) was evaluated with survival models. Secondary outcomes included operative outcomes and adverse events, and were evaluated with longitudinal models or contingency tables as appropriate. Results
A total of 183 participants (mean age, 66 years) were randomized, 175 were included in the trial, and 169 (97%) completed the 3-year follow-up. The primary outcome was not significantly different among women who underwent hysteropexy vs hysterectomy through 48 months (adjusted hazard ratio, 0.62 [95% CI, 0.38-1.02]; P = .06; 36-month adjusted failure incidence, 26% vs 38%). Mean (SD) operative time was lower in the hysteropexy group vs the hysterectomy group (111.5 [39.7] min vs 156.7 [43.9] min; difference, -45.2 [95% CI, -57.7 to -32.7]; P = <.001). Adverse events in the hysteropexy vs hysterectomy groups included mesh exposure (8% vs 0%), ureteral kinking managed intraoperatively (0% vs 7%), granulation tissue after 12 weeks (1% vs 11%), and suture exposure after 12 weeks (3% vs 21%). Conclusions and Relevance
Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery, vaginal mesh hysteropexy compared with vaginal hysterectomy with uterosacral ligament suspension did not result in a significantly lower rate of the composite prolapse outcome after 3 years. However, imprecision in study results precludes a definitive conclusion, and further research is needed to assess whether vaginal mesh hysteropexy is more effective than vaginal hysterectomy with uterosacral ligament suspension. Trial Registration
ClinicalTrials.gov Identifier: NCT01802281.
中文翻译：
阴道网状子宫固定术与子宫骶韧带悬吊术对子宫阴道脱垂女性治疗失败的影响
重要性 缝合根尖悬垂的阴道子宫切除术通常用于治疗子宫阴道脱垂。经阴道网状子宫固定术是另一种选择。目的比较阴道式子宫切除术与根尖悬吊缝合术与经阴道网状子宫固定术的疗效及不良反应。设计、设置、参与者 在美国盆底疾病网络的 9 个临床中心，183 名患有症状性子宫阴道脱垂的绝经后女性在 2013 年 4 月至 2015 年 2 月期间参加了一项随机优效临床试验。该研究旨在用于主要分析参与者在 2018 年 2 月达到了 3 年的随访。干预措施 93 名女性随机接受阴道网状子宫固定术，90 名女性随机接受子宫骶韧带悬吊术的阴道子宫切除术。主要结果和测量主要治疗失败复合结果（脱垂的再治疗、处女膜外脱垂或脱垂症状）用生存模型进行评估。次要结果包括手术结果和不良事件，并酌情使用纵向模型或列联表进行评估。结果 共有 183 名参与者（平均年龄 66 岁）被随机分组，175 人被纳入试验，169 人（97%）完成了 3 年的随访。48 个月内接受子宫固定术与子宫切除术的女性的主要结局无显着差异（调整后的风险比，0.62 [95% CI，0.38-1.02]；P = .06；36 个月调整后的失败发生率，26% 对 38%）。子宫固定术组的平均 (SD) 手术时间低于子宫切除术组（111.5 [39.7] 分钟 vs 156.7 [43.9] 分钟；差异，-45.2 [95% CI，-57.7 到 -32.7]；P = <.001 ）。子宫固定术组与子宫切除术组的不良事件包括网片暴露（8% 对 0%）、术中输尿管扭结处理（0% 对 7%）、12 周后肉芽组织（1% 对 11%）和 12 周后缝合线暴露（3% 对 21%）。结论和相关性 在接受阴道手术的有症状的子宫阴道脱垂的女性中，阴道网状子宫固定术与子宫骶韧带悬吊的阴道子宫切除术相比，3 年后复合脱垂结果的发生率并未显着降低。然而，研究结果的不精确性排除了一个明确的结论，阴道网状子宫固定术是否比子宫骶韧带悬吊的阴道子宫切除术更有效，还需要进一步研究。试验注册 ClinicalTrials.gov 标识符：NCT01802281。
更新日期：2019-09-17
中文翻译：
阴道网状子宫固定术与子宫骶韧带悬吊术对子宫阴道脱垂女性治疗失败的影响
重要性 缝合根尖悬垂的阴道子宫切除术通常用于治疗子宫阴道脱垂。经阴道网状子宫固定术是另一种选择。目的比较阴道式子宫切除术与根尖悬吊缝合术与经阴道网状子宫固定术的疗效及不良反应。设计、设置、参与者 在美国盆底疾病网络的 9 个临床中心，183 名患有症状性子宫阴道脱垂的绝经后女性在 2013 年 4 月至 2015 年 2 月期间参加了一项随机优效临床试验。该研究旨在用于主要分析参与者在 2018 年 2 月达到了 3 年的随访。干预措施 93 名女性随机接受阴道网状子宫固定术，90 名女性随机接受子宫骶韧带悬吊术的阴道子宫切除术。主要结果和测量主要治疗失败复合结果（脱垂的再治疗、处女膜外脱垂或脱垂症状）用生存模型进行评估。次要结果包括手术结果和不良事件，并酌情使用纵向模型或列联表进行评估。结果 共有 183 名参与者（平均年龄 66 岁）被随机分组，175 人被纳入试验，169 人（97%）完成了 3 年的随访。48 个月内接受子宫固定术与子宫切除术的女性的主要结局无显着差异（调整后的风险比，0.62 [95% CI，0.38-1.02]；P = .06；36 个月调整后的失败发生率，26% 对 38%）。子宫固定术组的平均 (SD) 手术时间低于子宫切除术组（111.5 [39.7] 分钟 vs 156.7 [43.9] 分钟；差异，-45.2 [95% CI，-57.7 到 -32.7]；P = <.001 ）。子宫固定术组与子宫切除术组的不良事件包括网片暴露（8% 对 0%）、术中输尿管扭结处理（0% 对 7%）、12 周后肉芽组织（1% 对 11%）和 12 周后缝合线暴露（3% 对 21%）。结论和相关性 在接受阴道手术的有症状的子宫阴道脱垂的女性中，阴道网状子宫固定术与子宫骶韧带悬吊的阴道子宫切除术相比，3 年后复合脱垂结果的发生率并未显着降低。然而，研究结果的不精确性排除了一个明确的结论，阴道网状子宫固定术是否比子宫骶韧带悬吊的阴道子宫切除术更有效，还需要进一步研究。试验注册 ClinicalTrials.gov 标识符：NCT01802281。
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