阴道网片治疗脱垂的随机临床试验的一年目标和功能结果。
One-year objective and functional outcomes of a randomized clinical trial of vaginal mesh for prolapse.
机构信息
Section of Female Pelvic Medicine and Reconstructive Surgery, Department of Women and Infants' Services, Washington Hospital Center/Georgetown University School of Medicine, Washington, DC, USA.
出版信息
Am J Obstet Gynecol. 2012 Jan;206(1):86.e1-9. doi: 10.1016/j.ajog.2011.08.003. Epub 2011 Aug 11.
OBJECTIVE
The purpose of this study was to show 12-month outcomes of a randomized trial that compared vaginal prolapse repair with and without mesh.
STUDY DESIGN
Women with stage ≥2 prolapse were assigned randomly to vaginal repair with or without mesh. The primary outcome was prolapse stage ≤1 at 12 months. Secondary outcomes included quality of life and complications.
RESULTS
All 65 evaluable participants were followed for 12 months after trial stoppage for mesh exposures. Thirty-two women had mesh repair; 33 women had traditional repair. At 12 months, both groups had improvement of pelvic organ prolapse-quantification test points to similar recurrence rates. The quality of life improved and did not differ between groups: 96.2% mesh vs 90.9% no-mesh subjects reported a cure of bulge symptoms; 15.6% had mesh exposures, and reoperation rates were higher with mesh.
CONCLUSION
Objective and subjective improvement is seen after vaginal prolapse repair with or without mesh. However, mesh resulted in a higher reoperation rate and did not improve 1-year cure.
目的
本研究旨在展示一项比较阴道脱垂修复术加用与不加用网片的随机试验的 12 个月结果。
研究设计
将≥2 期脱垂的女性随机分配至加用或不加用网片的阴道修复术。主要结局为 12 个月时脱垂程度≤1 级。次要结局包括生活质量和并发症。
结果
所有 65 名可评估的参与者在试验因网片暴露而停止后随访 12 个月。32 名女性接受了网片修复；33 名女性接受了传统修复。12 个月时，两组盆腔器官脱垂定量测试点均有改善，复发率相似。生活质量均得到改善且两组间无差异：96.2%的网片组和 90.9%的无网片组患者报告膨出症状治愈；15.6%出现网片暴露，网片组的再次手术率更高。
结论
阴道脱垂修复术加用或不加用网片后均能看到客观和主观的改善。然而，网片导致更高的再次手术率，且不能提高 1 年的治愈率。
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