Section of Female Pelvic Medicine and Reconstructive Surgery, Department of Women and Infants' Services, MedStar Washington Hospital Center/Georgetown University School of Medicine, Washington, DC; the Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, California; and MedStar Health Research Institute, Hyattsville, Maryland.
Obstet Gynecol. 2013 Oct;122(4):770-777. doi: 10.1097/AOG.0b013e3182a49dac.
To present the 3-year outcomes of a double-blind, multicenter, randomized trial comparing vaginal prolapse repair with and without mesh.
This was a planned final analysis of women with Pelvic Organ Prolapse Quantification (POP-Q) stage 2-4 prolapse randomized to traditional vaginal prolapse surgery without mesh and vaginal colpopexy repair with mesh. We evaluated anatomic, symptomatic, and combined cure rates for those with at least 3-year validated quality-of-life questionnaires and 2- or 3-year postoperative blinded POP-Q examination. Participants undergoing reoperation for recurrent prolapse were removed for anatomic and subjective outcomes analysis and considered failures for combined outcomes analysis.
Sixty-five women were enrolled (33 mesh, 32 no mesh) before the study was prematurely halted as a result of a 15.6% mesh exposure rate. At 3 years, 51 of 65 (78%) had quality-of-life questionnaires (25 mesh, 26 no mesh) and 41 (63%) had examinations. Three participants died, three required reoperation for recurrent prolapse (all in mesh group), and eight were lost to follow-up. No differences were observed between groups at 3 years for prolapse stage or individual prolapse points. Stage improved for each group (90% and 86%) from baseline to 3 years (P<.01). Symptomatic improvement was observed with no differences in scores between groups. Cure rates did not differ between groups using a variety of definitions, and anatomic cure was lowest for the anterior compartment.
There was no difference in 3-year cure rates when comparing patients undergoing traditional vaginal prolapse surgery without mesh with those undergoing vaginal colpopexy repair with mesh.
Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540.
: I.
介绍一项为期 3 年的、针对伴有和不伴有网片的阴道脱垂修复的双盲、多中心、随机试验的结果。
这是一项针对盆腔器官脱垂定量（POP-Q）分期 2-4 期脱垂患者的、预先计划的最终分析，这些患者被随机分配接受无网片的传统阴道脱垂手术和有网片的阴道穹窿修补术。我们评估了至少 3 年经过验证的生活质量问卷和 2 年或 3 年术后盲法 POP-Q 检查的患者的解剖学、症状和联合治愈率。对于因复发脱垂而再次手术的患者，我们对其进行了解剖学和主观结果分析，并将其视为联合结果分析的失败。
在研究因 15.6%的网片暴露率而提前停止之前，共有 65 名女性（33 名网片组，32 名无网片组）入组。3 年后，65 名患者中有 51 名（78%）有生活质量问卷（网片组 25 名，无网片组 26 名），41 名（63%）接受了检查。3 名患者死亡，3 名因复发脱垂而再次手术（均在网片组），8 名患者失访。3 年后，两组在脱垂分期或单个脱垂点方面均无差异。两组的脱垂分期均从基线改善到 3 年（90%和 86%，P<.01）。两组的症状均有改善，且组间评分无差异。使用多种定义，治愈率在两组间无差异，且前盆腔的解剖学治愈率最低。
在比较不伴有网片的传统阴道脱垂手术和伴有网片的阴道穹窿修补术的患者时，3 年治愈率无差异。
Clinicaltrials.gov，www.clinicaltrials.gov，NCT00475540。
I。
