阔筋膜与聚丙烯网片用于腹式骶骨阴道固定术的随机试验：5年随访
Randomized trial of fascia lata and polypropylene mesh for abdominal sacrocolpopexy: 5-year follow-up.
作者信息
Tate Susan B, Blackwell Linda, Lorenz Douglas J, Steptoe Margaret M, Culligan Patrick J
机构信息
Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology, & Women's Health, University of Louisville School of Medicine, Louisville, KY, USA.
出版信息
Int Urogynecol J. 2011 Feb;22(2):137-43. doi: 10.1007/s00192-010-1249-3. Epub 2010 Aug 27.
INTRODUCTION AND HYPOTHESIS
The purpose of this study is to evaluate the 5-year surgical outcomes of abdominal sacrocolpopexy among subjects randomized to receive polypropylene mesh or cadaveric fascia lata.
METHODS
All 100 subjects from the original randomized clinical trial were eligible. Primary outcome was objective anatomic failure: any pelvic organ prolapse quantification (POP-Q) point ≥ - 1. Secondary outcome was clinical failure-presence of bulge or prolapse symptoms and either a POP-Q point C ≥ ½ TVL or any POP-Q point >0-and interim surgical re-treatment. Wilcoxon tests and Fisher's exact test were performed.
RESULTS
Fifty-eight subjects returned for 5-year follow-up-29 mesh and 29 fascia. Objective anatomic success rates were: mesh, 93% (27/29) and fascia, 62% (18/29) (p = 0.02). Clinical success rates were: mesh, 97% (28/29) and fascia, 90% (26/29) (p = 0.61).
CONCLUSIONS
Polypropylene mesh was superior to cadaveric fascia lata using objective anatomic outcomes. Success rates of mesh and fascia were comparable using a clinical definition that combined symptoms with anatomic measures.
引言与假设
本研究的目的是评估随机接受聚丙烯网片或尸体阔筋膜的受试者行腹骶骨阴道固定术的5年手术效果。
方法
来自原随机临床试验的所有100名受试者均符合条件。主要结局是客观解剖学失败：任何盆腔器官脱垂定量（POP-Q）点≥ -1。次要结局是临床失败——存在膨出或脱垂症状，且POP-Q点C≥ ½ TVL或任何POP-Q点>0——以及中期手术再治疗。进行了Wilcoxon检验和Fisher精确检验。
结果
58名受试者返回进行5年随访——29名使用网片，29名使用筋膜。客观解剖学成功率分别为：网片组93%（27/29），筋膜组62%（18/29）（p = 0.02）。临床成功率分别为：网片组97%（28/29），筋膜组90%（26/29）（p = 0.61）。
结论
使用客观解剖学结局时，聚丙烯网片优于尸体阔筋膜。使用将症状与解剖学测量相结合的临床定义时，网片和筋膜的成功率相当。
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