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机器人辅助骶骨阴道固定术与阴道网片修复盆腔器官脱垂术后1年的质量调整生命年结局

Quality-Adjusted Life-Years Outcome 1 Year After Surgery by Robotics-Assisted Sacral Hystero-Colpopexy Versus Vaginal Mesh for Pelvic Organ Prolapse Repair.

作者信息

Poutakidis Georgios, Geale Kirk, Morcos Edward

机构信息

Department of Clinical Sciences, Division of Obstetrics and Gynecology, Karolinska Institutet Danderyd Hospital, 176 77, Stockholm, Sweden.

Department of Obstetrics and Gynecology, Danderyd University Hospital, 182 88, Danderyd, Stockholm, Sweden.

出版信息

Int Urogynecol J. 2025 Aug 13. doi: 10.1007/s00192-025-06242-7.

DOI:10.1007/s00192-025-06242-7
PMID:40801945
Abstract

INTRODUCTION AND HYPOTHESIS

The aim of this study was to compare the quality-adjusted life-years (QALYs) attained 1 year after robotics-assisted sacral hystero-colpopexy (RASC) versus Uphold™ vaginal mesh surgery for pelvic organ prolapse repair.

METHODS

This was a secondary analysis of a previously published cohort study. A total of 65 patients who underwent RASC and 71 who underwent the Uphold™ procedure completed the 15-dimensional (15D) and the EuroQol five-dimensional three-level (EQ-5D-3L) instruments measuring health-related quality of life (HR-QoL). All patients had symptomatic and anatomical apical prolapse (POP-Q C ≥ stage II) with or without other vaginal wall defects. Changes in HR-QoL instruments were calculated and compared with minimal important change (MIC) thresholds and QALYs gained were estimated for each intervention.

RESULTS

The 15D and EQ-5D-3L mean index scores were improved from preoperatively to 1 year after RASC ([0.88 ± 0.10 to 0.90 ± 0.01] and [0.85 ± 0.1 to 0.90 ± 0.1]) and after Uphold™= ([0.87 ± 0.1 to 0.89 ± 0.1] and [0.86 ± 0.1 to 0.93 ± 0.1], p 0.024 to p < 0.001) with no significant difference between cohorts. Prolapse-related 15D profile index measures, including discomfort, sexual activity, and distress were significantly improved after RASC (p = 0.039 to < 0.001), whereas excretion, discomfort, and sexual activity were significantly improved after the Uphold™ (p = 0.009 to < 0.001). The improvement in 15D scores from baseline to 1-year follow-up of + 0.026 for RASC and + 0.025 for Uphold™ exceeded the MIC, indicating meaningful improvements in patient quality of life. The overall 1-year QALY gain was estimated to be 0.90 ± 0.1 in the RASC and 0.88 ± 0.1 in the Uphold™ cohorts (p < 0.001), with no significant difference between the two interventions (p = 0.514).

CONCLUSIONS

The RASC and Uphold™ are both meaningful surgical treatments for prolapse, with significant improvement in the HR-QoL and the 1-year QALY gain and with no significant difference between the two surgeries.

摘要

引言与假设

本研究旨在比较机器人辅助骶骨子宫阴道固定术(RASC)与Uphold™阴道网片手术治疗盆腔器官脱垂1年后所获得的质量调整生命年(QALY)。

方法

这是对先前发表的队列研究的二次分析。共有65例行RASC手术的患者和71例行Uphold™手术的患者完成了测量健康相关生活质量(HR-QoL)的15维度(15D)和欧洲五维度三级(EQ-5D-3L)量表。所有患者均有症状性和解剖学上的顶端脱垂(盆腔器官脱垂定量分期系统[POP-Q] C≥II期),伴有或不伴有其他阴道壁缺陷。计算HR-QoL量表的变化,并与最小重要变化(MIC)阈值进行比较,同时估计每种干预措施所获得的QALY。

结果

RASC术后1年和Uphold™术后1年,15D和EQ-5D-3L的平均指数评分均较术前有所改善([0.88±0.10至0.90±0.01]和[0.85±0.1至0.90±0.1]以及[0.87±0.1至0.89±0.1]和[0.86±0.1至0.93±0.1],p值为0.024至p<0.001),两组之间无显著差异。RASC术后,与脱垂相关的15D剖面指数测量值,包括不适、性活动和困扰均有显著改善(p=0.039至<0.001),而Uphold™术后排泄、不适和性活动有显著改善(p=0.009至<0.001)。从基线到1年随访,RASC组15D评分提高了+0.026,Uphold™组提高了+0.025,均超过了MIC,表明患者生活质量有有意义的改善。RASC组1年总的QALY增益估计为0.90±0.1,Uphold™组为0.88±0.1(p<0.001),两种干预措施之间无显著差异(p=0.514)。

结论

RASC和Uphold™都是治疗脱垂的有效手术方法,均能显著改善HR-QoL和1年的QALY增益,两种手术之间无显著差异。

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本文引用的文献

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Pelvic Organ Prolapse Repair Using Robotic-Assisted Sacral Hysterocolpopexy vs Vaginal Surgery with the Uphold™ System: 1-Year Clinical Outcomes.使用机器人辅助骶骨子宫阴道固定术与采用Uphold™系统的阴道手术治疗盆腔器官脱垂:1年临床结果
Int Urogynecol J. 2025 Mar;36(3):585-597. doi: 10.1007/s00192-024-06017-6. Epub 2025 Jan 8.
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Apical Suspension Repair for Vaginal Vault Prolapse: A Randomized Clinical Trial.经阴道穹隆顶端悬吊修复术治疗阴道穹隆脱垂:一项随机临床试验。
JAMA Surg. 2024 Aug 1;159(8):845-855. doi: 10.1001/jamasurg.2024.1206.
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Surgery for women with apical vaginal prolapse.
阴道顶端脱垂妇女的手术治疗。
Cochrane Database Syst Rev. 2023 Jul 26;7(7):CD012376. doi: 10.1002/14651858.CD012376.pub2.
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Contemporary Use and Techniques of Laparoscopic Sacrocolpopexy With or Without Robotic Assistance for Pelvic Organ Prolapse.腹腔镜骶骨阴道固定术(或联合机器人辅助手术)在盆腔器官脱垂中的应用现状和技术要点。
Obstet Gynecol. 2022 May 1;139(5):922-932. doi: 10.1097/AOG.0000000000004761. Epub 2022 Apr 5.
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Comparing the outcomes and effectiveness of robotic-assisted sacrocolpopexy and laparoscopic sacrocolpopexy in the treatment of pelvic organ prolapse.比较机器人辅助骶骨阴道固定术和腹腔镜骶骨阴道固定术治疗盆腔器官脱垂的疗效。
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J Obstet Gynaecol Can. 2021 Apr;43(4):511-523.e1. doi: 10.1016/j.jogc.2021.02.001. Epub 2021 Feb 3.
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Long-term outcomes of pelvic organ prolapse repair using a mesh-capturing device when comparing single- versus multicenter use.比较单中心与多中心使用网兜捕获器修复盆腔器官脱垂的长期疗效。
Arch Gynecol Obstet. 2021 Jan;303(1):135-142. doi: 10.1007/s00404-020-05764-3. Epub 2020 Sep 11.
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The international discussion and the new regulations concerning transvaginal mesh implants in pelvic organ prolapse surgery.关于盆腔器官脱垂手术中经阴道网状植入物的国际讨论及新规定。
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A long-term comparative study of Uphold™ transvaginal mesh kit against anterior colporrhaphy.UpholdTM 经阴道网片套件与前阴道修补术的长期对比研究。
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Clinical evaluation of the Uphold LITE mesh for the surgical treatment of anterior and apical prolapse: A prospective, multicentre trial.经阴道前壁和前顶脱垂手术治疗中采用 Uphold LITE 网片的临床评估:一项前瞻性、多中心试验。
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