Outcome after anterior vaginal prolapse repair - A randomized controlled trial

Outcome after anterior vaginal prolapse repair - A randomized controlled trial
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DOI:
10.1097/aog.0b013e31816a2489
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发表时间:
2008-04-01
影响因子:
7.2
通讯作者:
Burchette, Raoul J.
Burchette, Raoul J.
中科院分区:
医学2区
文献类型:
--
作者:
Nguyen, John N.;Burchette, Raoul J.

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目标:报告一项随机对照试验的1年结果,比较聚丙烯网加强阴道前脱垂修补术与前colporrhaphy.METHODS:76例II期或更高的阴道前脱垂患者被随机分配到阴道修补术或聚丙烯网修补术。主要结果是复发II期前阴道脱垂,和次要结果的影响生活质量和性症状评分,手术时间,失血量,住院时间,和adverse events.Results:38名妇女有前阴道缝合术,37聚丙烯网片修复。1例分配接受补片修复的患者在术前退出研究。两个治疗组之间的临床和人口统计学数据无显著差异。术后1年,阴道缝合组38例中有21例(55%)获得了最佳和满意的阴道前壁支撑,补片组38例中有33例(87%)获得了最佳和满意的阴道前壁支撑(P= 0.005)。两组患者均报告手术后脱垂和泌尿系统症状的困扰较少。阴道缝合术组和补片组的新发性交困难发生率分别为4/26(16%)和2/23(9%)。37例患者中有2例(5%)发生阴道补片挤出。9名前阴道缝合术患者必须有复发性前阴道脱垂,以防止1例阴道补片挤出。两组均未发生严重不良事件或死亡。结论:前阴道脱垂修补术与聚丙烯网加固术相比,一年后的解剖复发率较低。然而,两组的生活质量和性症状评分均有所改善。临床试验注册:ClinicalTrials.gov,www.clinicaltrials.gov,NCT 00535301。
OBJECTIVES: To report 1-year outcomes of a randomized controlled trial comparing polypropylene mesh-reinforced anterior vaginal prolapse repair with anterior colporrhaphy.METHODS: Seventy-six patients with stage II or greater anterior vaginal prolapse were randomly assigned to either colporrhaphy or polypropylene mesh repair. The primary outcome was recurrent stage II anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, blood loss, length of hospitalization, and adverse events.RESULTS: Thirty-eight women had anterior colporrhaphy, and 37 had polypropylene mesh repair. One patient allocated to mesh repair withdrew from the study before surgery. Clinical and demographic data did not differ significantly between the two treatment groups. One year after surgery, optimal and satisfactory anterior vaginal support were obtained in 21 of 38 (55%) of the colporrhaphy group and 33 of 38 (87%) of the mesh group (P=.005). Patients in both groups reported less bother after surgery in both prolapse and urinary symptoms. The rates of de novo dyspareunia were 4 of 26 (16%) and 2 of 23 (9%) in the colporrhaphy and mesh groups, respectively. Two of 37 (5%) patients had vaginal mesh extrusion. Nine anterior colporrhaphy patients would have to have recurrent anterior vaginal prolapse to prevent one vaginal mesh extrusion. Neither serious adverse events nor deaths occurred in either group.CONCLUSION: Anterior vaginal prolapse repair with polypropylene mesh reinforcement offers lower anatomic recurrence than anterior colporrhaphy at one year. However, quality of life and sexual symptoms scores improved in both groups.CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00535301.