Júlia Ács , Anett Szabó , Péter Fehérvári , Andrea Harnos , Benjamin Skribek , Martin Tenke , Tibor Szarvas , Péter Nyirády , Nándor Ács , Péter Hegyi , Attila Majoros
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Randomised controlled trials and observational studies comparing the safety and efficacy of vaginal POP surgery with implants versus native tissue were included. Safety outcomes were defined as different types of complications (functional and non-functional) and reoperations for complications. Efficacy outcomes were parameters of anatomical success and the rate of reoperations due to recurrence. A multivariate meta-analysis framework was used to estimate pooled odds ratios (ORs) with confidence intervals (CIs) with simultaneous control for study correlations and estimation of multiple correlated outcomes.</div></div><div><h3>Evidence synthesis</h3><div>We included 50 comparative studies in the analysis. Rates of reoperation for complications (OR 2.15, 95% CI 1.20–3.87), vaginal erosion (OR 14.05, 95% CI 9.07–21.77), vaginal bleeding (OR 1.67, 95% CI 1.25–2.23), and de novo stress urinary incontinence (OR 1.44, 95% CI 1.18–1.75) were significantly higher in the implant group. Rates of anatomical success (OR 3.22, 95% CI 2.06–5.0) and reoperation for recurrence (OR 0.55, 95% CI 0.36–0.85) were superior in the implant group.</div></div><div><h3>Conclusions</h3><div>POP surgeries with vaginal implants are more effective than surgeries without implants, with acceptable complication rates. Therefore, the complete prohibition of implants for POP surgeries should be reconsidered.</div></div><div><h3>Patient summary</h3><div>We compared vaginal surgery with and without implants for repair of pelvic organ prolapse. 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However, owing to perceived complications, vaginal implant surgeries have been restricted or banned in many countries.</div></div><div><h3>Objective</h3><div>To assess the real value of vaginal implants in POP surgery and compare the safety and efficacy of operations with and without implants.</div></div><div><h3>Evidence acquisition</h3><div>A systematic search was performed in three medical databases. Randomised controlled trials and observational studies comparing the safety and efficacy of vaginal POP surgery with implants versus native tissue were included. Safety outcomes were defined as different types of complications (functional and non-functional) and reoperations for complications. Efficacy outcomes were parameters of anatomical success and the rate of reoperations due to recurrence. A multivariate meta-analysis framework was used to estimate pooled odds ratios (ORs) with confidence intervals (CIs) with simultaneous control for study correlations and estimation of multiple correlated outcomes.</div></div><div><h3>Evidence synthesis</h3><div>We included 50 comparative studies in the analysis. Rates of reoperation for complications (OR 2.15, 95% CI 1.20–3.87), vaginal erosion (OR 14.05, 95% CI 9.07–21.77), vaginal bleeding (OR 1.67, 95% CI 1.25–2.23), and de novo stress urinary incontinence (OR 1.44, 95% CI 1.18–1.75) were significantly higher in the implant group. Rates of anatomical success (OR 3.22, 95% CI 2.06–5.0) and reoperation for recurrence (OR 0.55, 95% CI 0.36–0.85) were superior in the implant group.</div></div><div><h3>Conclusions</h3><div>POP surgeries with vaginal implants are more effective than surgeries without implants, with acceptable complication rates. 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引用次数: 0
摘要
背景:在盆腔器官脱垂(POP)的许多手术治疗中,阴道植入物可以取得较好的效果。然而,由于认为存在并发症,阴道植入手术在许多国家受到限制或禁止。目的:评价阴道植入物在POP手术中的实际应用价值,比较有无植入物的安全性和有效性。证据获取:在三个医学数据库中进行了系统的搜索。包括随机对照试验和观察性研究,比较阴道POP手术植入物与天然组织的安全性和有效性。安全性结果定义为不同类型的并发症(功能性和非功能性)和并发症的再手术。疗效结果是解剖成功率和复发再手术率的参数。使用多变量荟萃分析框架来估计具有置信区间(ci)的合并优势比(ORs),同时控制研究相关性和估计多个相关结果。证据综合:我们在分析中纳入了50项比较研究。再手术并发症(OR 2.15, 95% CI 1.20-3.87)、阴道糜烂(OR 14.05, 95% CI 9.07-21.77)、阴道出血(OR 1.67, 95% CI 1.25-2.23)和新发压力性尿失禁(OR 1.44, 95% CI 1.18-1.75)的发生率在种植组中显著高于对照组。种植体组解剖成功率(OR 3.22, 95% CI 2.06-5.0)和复发再手术率(OR 0.55, 95% CI 0.36-0.85)均优于前者。结论:有阴道植入物的POP手术比无阴道植入物的手术更有效,并发症发生率可接受。因此,完全禁止植入物用于POP手术应该重新考虑。患者总结:我们比较了有和没有植入物的阴道手术修复盆腔器官脱垂。尽管并发症发生率较高,但阴道植入总体上比不植入的手术提供更好的长期效果。
Safety and Efficacy of Vaginal Implants in Pelvic Organ Prolapse Surgery: A Meta-analysis of 161 536 Patients
Context
Among the many surgical treatments for pelvic organ prolapse (POP), better results can be achieved with the use of vaginal implants. However, owing to perceived complications, vaginal implant surgeries have been restricted or banned in many countries.
Objective
To assess the real value of vaginal implants in POP surgery and compare the safety and efficacy of operations with and without implants.
Evidence acquisition
A systematic search was performed in three medical databases. Randomised controlled trials and observational studies comparing the safety and efficacy of vaginal POP surgery with implants versus native tissue were included. Safety outcomes were defined as different types of complications (functional and non-functional) and reoperations for complications. Efficacy outcomes were parameters of anatomical success and the rate of reoperations due to recurrence. A multivariate meta-analysis framework was used to estimate pooled odds ratios (ORs) with confidence intervals (CIs) with simultaneous control for study correlations and estimation of multiple correlated outcomes.
Evidence synthesis
We included 50 comparative studies in the analysis. Rates of reoperation for complications (OR 2.15, 95% CI 1.20–3.87), vaginal erosion (OR 14.05, 95% CI 9.07–21.77), vaginal bleeding (OR 1.67, 95% CI 1.25–2.23), and de novo stress urinary incontinence (OR 1.44, 95% CI 1.18–1.75) were significantly higher in the implant group. Rates of anatomical success (OR 3.22, 95% CI 2.06–5.0) and reoperation for recurrence (OR 0.55, 95% CI 0.36–0.85) were superior in the implant group.
Conclusions
POP surgeries with vaginal implants are more effective than surgeries without implants, with acceptable complication rates. Therefore, the complete prohibition of implants for POP surgeries should be reconsidered.
Patient summary
We compared vaginal surgery with and without implants for repair of pelvic organ prolapse. Despite higher complication rates, vaginal implants provide better long-term results overall than surgery without implants.
期刊介绍:
European Urology Focus is a new sister journal to European Urology and an official publication of the European Association of Urology (EAU).
EU Focus will publish original articles, opinion piece editorials and topical reviews on a wide range of urological issues such as oncology, functional urology, reconstructive urology, laparoscopy, robotic surgery, endourology, female urology, andrology, paediatric urology and sexual medicine. The editorial team welcome basic and translational research articles in the field of urological diseases. Authors may be solicited by the Editor directly. All submitted manuscripts will be peer-reviewed by a panel of experts before being considered for publication.