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Comparison of absorbable and permanent sutures for laparoscopic sacrocervicopexy: A randomized controlled trial.

可吸收缝线和永久缝线用于腹腔镜骶颈固定术的比较: 一项随机对照试验。

  • 影响因子:2.21
  • DOI:10.1111/aogs.13997
  • 作者列表:"Tagliaferri V","Ruggieri S","Taccaliti C","Gentile C","Didonna T","D'asta M","Legge F","Guida P","Scambia G","Guido M
  • 发表时间:2021-02-01
Abstract

INTRODUCTION:Pelvic organ prolapse is a common cause of morbidity and decreased quality of life among women and is treatable by laparoscopic sacrocolpopexy. Recent data suggest that absorbable sutures are a feasible and appealing option for mesh attachment given a potential decreased risk of complications related to mesh erosion. The aim of the present study was to demonstrate the non-inferiority of absorbable sutures to permanent sutures for laparoscopic sacrocervicopexy. MATERIAL AND METHODS:We performed a randomized, single-blinded, non-inferiority trial comparing late-absorbable sutures (group A) to non-absorbable sutures (group B) for anterior and posterior vaginal mesh fixation during laparoscopic sacrocervicopexy at a single center in Italy. The primary outcome was prolapse correction at 12 months after surgery, defined as the absence of a pelvic organ prolapse leading edge reaching or extending below the level of the hymen and the absence of bulge symptoms. Secondary outcomes included intraoperative parameters, postoperative characteristics, and long-term morbidity. Statistical analyses were performed using STATA version 16. RESULTS:A total of 150 patients with pelvic organ prolapse were prospectively randomized 1:1 into two groups (A or B). Baseline characteristics and intraoperative parameters including blood loss, operation time, and intraoperative complications were comparable between groups. The success rate was 100% in both groups and no differences in prolapse correction were observed. The rates of de novo urinary incontinence and persistent urinary incontinence were also similar between groups. The rate of mesh erosion at 12 months was 0% in group A and 4% in group B (P = .24). CONCLUSIONS:Late absorbable sutures are non-inferior to non-absorbable sutures for laparoscopic sacrocervicopexy in terms of procedural success. Moreover we did not see any differences in terms of operative parameters, or intraoperative and postoperative characteristics, although the study was not powered to these outcomes.

摘要

引言: 盆腔器官脱垂是女性发病率和生活质量下降的常见原因,可通过腹腔镜骶前固定术治疗。最近的数据表明,考虑到与网片侵蚀相关的并发症风险的潜在降低,可吸收缝合线是网片附着的可行且有吸引力的选择。本研究的目的是证明可吸收缝线与永久性缝线用于腹腔镜骶颈固定术的非劣效性。 材料和方法: 我们进行了一项随机、单盲、非劣效性试验,比较了意大利单一中心腹腔镜骶颈固定术中晚期可吸收缝线 (a组) 和非可吸收缝线 (B组) 的前阴道网片和后阴道网片固定。主要结局是术后12个月的脱垂矫正,定义为没有达到或延伸至处女膜水平以下的盆腔器官脱垂前缘,并且没有隆起症状.次要结局包括术中参数、术后特征和长期发病率。使用STATA版本16进行统计分析。 结果: 共有150例盆腔器官脱垂患者被前瞻性地1:1随机分为两组 (A或B)。两组的基线特征和术中参数 (包括出血量、手术时间和术中并发症) 具有可比性。两组成功率均为100%,脱垂矫正无差异。组间新发尿失禁和持续性尿失禁的发生率也相似。A组12个月时网片糜烂率为0%,B组为4% (P = .24)。 结论: 就手术成功率而言,晚期可吸收缝线不劣于不可吸收缝线用于腹腔镜骶颈固定术。此外,我们在手术参数或术中及术后特征方面没有发现任何差异,尽管本研究对这些结果没有影响。

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