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经阴道聚四氟乙烯网片 O.R.I.H.I.M.E. 手术治疗前盆腔器官脱垂是否可行?-O.R.I.H.I.M.E.与 Polyform™ 之间的随机对照研究。

Is transvaginal mesh surgery with polytetrafluoroethylene mesh ORIHIME feasible for anterior pelvic organ prolapse?-Randomized comparative study between ORIHIME and Polyform™.

机构信息

Urogynecology Center, First Towakai Hospital, Osaka, Japan.

Urology Department, Kitasaito Hospital, Asahikawa, Hokkaido, Japan.

出版信息

Int J Urol. 2024 Sep;31(9):1017-1021. doi: 10.1111/iju.15506. Epub 2024 Jun 5.

DOI:10.1111/iju.15506
PMID:38840427
Abstract

OBJECTIVE

Transvaginal mesh surgery for pelvic organ prolapse has been widely performed in Japan, but polypropylene mesh has not been used in Japan since the ban on TVM using polypropylene mesh in the United States. Currently, polytetrafluoroethylene mesh ORIHIME® is the only mesh available for TVM in Japan. Although polytetrafluoroethylene is a safe material, its low coefficient of friction and insufficient adhesion to the surrounding tissue make it difficult to maintain the mesh position when it is used in the transvaginal mesh surgery. The aim of this study was to evaluate the feasibility of TVM-A2 using ORIHIME®.

METHODS

One hundred cases of TVM-A2 were included in the study. The patients were randomly assigned to two groups: the ORIHIME® group (Group O) and the Polyform group (Group P). With 50 patients in each group, the complications and recurrences up to the fourth year were compared. Surgeries were performed using the TVM-A2 method. Statistical analysis was performed using EZR.

RESULTS

There were no significant differences in baseline parameters between the two groups. We observed no perioperative complications, and saw one case of postoperative abscess formation in Group O, which resolved successfully after incision and drainage. The 4-year recurrence rate was significantly higher in Group O.

CONCLUSION

As the recurrence rate was significantly higher in Group O, we conclude that TVM-A2 using ORIHIME® which is the same procedure as TVM-A2 using polypropylene mesh is not feasible in repairing the pelvic organ prolapse.

摘要

目的

经阴道网片修补术(TVM)已在日本广泛应用于治疗盆腔器官脱垂,但在美国禁用聚丙烯网片后,日本也停止使用聚丙烯网片。目前,日本 TVM 中唯一可使用的网片是聚四氟乙烯网片 ORIHIME®。虽然聚四氟乙烯是一种安全的材料,但由于其摩擦系数低,与周围组织的附着力不足,当用于 TVM 时,很难维持网片的位置。本研究旨在评估使用 ORIHIME®进行 TVM-A2 的可行性。

方法

本研究纳入了 100 例 TVM-A2 患者。患者被随机分为两组:ORIHIME®组(O 组)和 Polyform 组(P 组)。每组各有 50 例患者,比较两组至第四年的并发症和复发情况。手术采用 TVM-A2 方法进行。使用 EZR 进行统计学分析。

结果

两组患者的基线参数无显著差异。我们未观察到围手术期并发症,O 组有 1 例术后脓肿形成,经切开引流后痊愈。O 组的 4 年复发率显著较高。

结论

由于 O 组的复发率显著较高,我们认为使用 ORIHIME®进行 TVM-A2 与使用聚丙烯网片进行 TVM-A2 一样不可行,无法有效治疗盆腔器官脱垂。

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