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与其他材料相比,使用聚偏二氟乙烯(PVDF)进行盆腔器官脱垂/尿失禁(POP/UI)手术后的手术结果。一项系统评价和荟萃分析。

Surgical results in POP/UI surgery after using PVDF compared to other materials. A systematic review and meta-analysis.

作者信息

Karalis Tilemachos, Tsiapakidou Sofia, Grimbizis Grigoris F, Mikos Themistoklis

机构信息

1(st) Department of Obstetrics and Gynecology, "Papageorgiou" General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.

1(st) Department of Obstetrics and Gynecology, "Papageorgiou" General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2023 May;284:110-119. doi: 10.1016/j.ejogrb.2023.03.018. Epub 2023 Mar 21.

Abstract

OBJECTIVES

Synthetic materials have been used for the surgical treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). During the last 25 years, these materials were composed mostly of polypropylene (PP), whereas recently the use of polyvinylidene difluoride (PVDF) is of increasing interest due to its characteristics. This study aimed to compare the results after SUI/POP surgery using PVDF versus PP materials by synthesizing the data of relevant existing literature.

STUDY DESIGN

This systematic review and meta-analysis included clinical trials, case-control studies, or cohort studies written in the English language. The search strategy included the electronic databases MEDLINE, EMBASE, and Cochrane, and grey literature (congresses IUGA, EUGA, AUGS, FIGO). All studies have to provide numeric data or odds ratios (OR) of developing a specific outcome in surgeries with PVDF compared with outcomes of other used materials. No restrictions of race or ethnicity were applied, nor chronological restrictions. Exclusion criteria were studies that included patients with cognitive impairment, dementia, stroke, or central nervous system trauma. All studies were screened by two reviewers, initially by title and abstract, and afterward by full text. Disagreements were resolved through mutual consent. All studies were assessed for their quality and bias risk. Data were extracted using a data extraction form formulated in a Microsoft Excel spreadsheet. Our results were divided into studies dealing only with SUI patients, studies dealing only with POP patients, and cumulative analysis of variables expressed in both SUI and POP surgery. The primary outcomes were the rates of post-operative recurrence, mesh erosion, and postoperative pain after surgery with PVDF compared to PP. The secondary outcomes were post-operative sexual dissatisfaction, overall satisfaction rates, hematoma, urinary tract infection, de novo urge incontinence, and reoperation rate.

RESULTS

No differences in the post-operative rates of SUI/POP recurrence, mesh erosion, and pain were found after surgery with PVDF vs surgery with PP. Patients after SUI surgery with PVDF tapes had statistically significant lower rates of de-novo urgency compared to the PP group [OR = 0.38 (0.18, 0.88), p = 0.01]; patients after POP surgery with PVDF materials had statistically significant lower rates of de-novo sexual dysfunction compared to the PP group [OR = 0.12 (0.03, 0.46), p = 0.002].

CONCLUSIONS

This study provided evidence that the use of PVDF in SUI/POP surgeries could be a valid alternative to PP. However our results are limited by uncertainty due to the overall low quality of the existent data. Further research and validation would contribute to better surgical techniques.

摘要

目的

合成材料已用于压力性尿失禁(SUI)和盆腔器官脱垂(POP)的手术治疗。在过去25年中,这些材料主要由聚丙烯(PP)制成,而最近聚偏二氟乙烯(PVDF)因其特性而越来越受到关注。本研究旨在通过综合现有相关文献的数据,比较使用PVDF与PP材料进行SUI/POP手术后的结果。

研究设计

本系统评价和荟萃分析纳入了用英语撰写的临床试验、病例对照研究或队列研究。检索策略包括电子数据库MEDLINE、EMBASE和Cochrane,以及灰色文献(国际尿控协会、欧洲泌尿妇科协会、美国妇科腹腔镜医师协会、国际妇产科联合会的会议文献)。所有研究都必须提供与其他使用材料的手术结果相比,使用PVDF进行手术时出现特定结果的数值数据或比值比(OR)。不适用种族或民族限制,也不设时间限制。排除标准为纳入认知障碍、痴呆、中风或中枢神经系统创伤患者的研究。所有研究均由两名审阅者进行筛选,首先通过标题和摘要,然后通过全文。分歧通过双方同意解决。所有研究均评估其质量和偏倚风险。使用Microsoft Excel电子表格中制定的数据提取表提取数据。我们的结果分为仅涉及SUI患者的研究、仅涉及POP患者的研究,以及SUI和POP手术中表达的变量的累积分析。主要结果是与PP相比,使用PVDF手术后的术后复发率、网片侵蚀率和术后疼痛率。次要结果是术后性不满、总体满意率、血肿、尿路感染、新发急迫性尿失禁和再次手术率。

结果

与使用PP进行手术相比,使用PVDF进行手术后,SUI/POP复发、网片侵蚀和疼痛的术后发生率没有差异。与PP组相比,使用PVDF吊带进行SUI手术后的患者新发尿急率在统计学上显著较低[OR = 0.38(0.18,0.88),p = 0.01];与PP组相比,使用PVDF材料进行POP手术后的患者新发性功能障碍率在统计学上显著较低[OR = 0.12(0.03,0.46),p = 0.002]。

结论

本研究提供的证据表明,在SUI/POP手术中使用PVDF可能是PP的有效替代方案。然而,由于现有数据的总体质量较低,我们的结果受到不确定性的限制。进一步的研究和验证将有助于改进手术技术。

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