Steures Pieternel, Milani Alfredo L, van Rumpt-van de Geest Deliana A, Kluivers Kirsten B, Withagen Mariëlla I J
Department of Obstetrics and Gynaecology, Reinier de Graaf Gasthuis, Delft, The Netherlands.
Department of Obstetrics and Gynaecology, Jeroen Bosch Ziekenhuis, Postbus 90153, 5200 ME, Den Bosch, The Netherlands.
Int Urogynecol J. 2019 Apr;30(4):565-573. doi: 10.1007/s00192-018-3757-5. Epub 2018 Aug 29.
The objective was to compare medium-term efficacy and safety of a partially absorbable mesh kit and native tissue repair in pelvic organ prolapse (POP).
Women with primary POP stage ≥ II were randomized to transvaginal trocar-guided partially absorbable mesh (81 women) or native tissue repair (82 women). Primary outcome was overall anatomical success (POP < stage II) at 24 months. Secondary outcomes were composite success, global improvement, and adverse events.
Sixty-nine (85%) of the women allocated to partially absorbable mesh underwent mesh surgery; 8 (10%) crossed over to native tissue repair and 4 women (5%) withdrew from the study. Eighty (98%) of the women allocated to native tissue repair underwent the assigned treatment and 2 (2%) withdrew. Twenty-four months later, 140 surgically treated women (89%) demonstrated an overall anatomical success of 39%; 45% (32 out of 71 women) for mesh, and 32% (22 out of 69) for native tissue repair (RR 1.4, 95% CI 0.92 to 2.2). Composite success was 88 and 73% respectively (RR: 1.1, 95% CI 0.93 to 1.4). There was global improvement in 86% (48 out of 56 women) in the mesh group and in 77% (47 out of 60 women) in the native tissue group (RR: 1.1, 95% CI 0.92 to 1.3). Four women were diagnosed with mesh exposure at 2 years (6%).
At 24 months, no significant anatomical or composite benefit of partially absorbable mesh over native tissue repair could be demonstrated in women who had been surgically treated for primary POP.
目的是比较盆腔器官脱垂（POP）患者中，部分可吸收网片套件与自体组织修复的中期疗效和安全性。
原发性POP≥II期的女性被随机分为经阴道套管针引导的部分可吸收网片组（81例女性）或自体组织修复组（82例女性）。主要结局为24个月时的总体解剖学成功（POP＜II期）。次要结局为综合成功、整体改善情况及不良事件。
分配至部分可吸收网片组的69例（85%）女性接受了网片手术；8例（10%）转为自体组织修复，4例（5%）退出研究。分配至自体组织修复组的80例（98%）女性接受了指定治疗，2例（2%）退出。24个月后，140例接受手术治疗的女性（89%）总体解剖学成功率为39%；网片组为45%（71例女性中的32例），自体组织修复组为32%（69例中的22例）（相对危险度1.4，95%置信区间0.92至2.2）。综合成功率分别为88%和73%（相对危险度：1.1，95%置信区间0.93至1.4）。网片组86%（56例女性中的48例）有整体改善，自体组织组为77%（60例中的47例）（相对危险度：1.1，95%置信区间0.92至1.3）。2年时有4例女性被诊断为网片暴露（6%）。
对于接受原发性POP手术治疗的女性，在24个月时，未显示部分可吸收网片相对于自体组织修复有显著的解剖学或综合益处。
