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阴道前壁脱垂:SIS移植物与传统阴道修补术的随机对照试验

Anterior vaginal wall prolapse: a randomized controlled trial of SIS graft versus traditional colporrhaphy.

作者信息

Feldner Paulo Cezar, Castro Rodrigo Aquino, Cipolotti Luiz Antonio, Delroy Carlos Antonio, Sartori Marair Gracio Ferreira, Girão Manoel João Batista Castello

机构信息

Section of Urogynecology and Pelvic Surgery, Department of Gynecology, Universidade Federal de São Paulo, Rua dos Otonis, 601 (Vila Clementino), 04025-001, São Paulo, SP, Brazil.

出版信息

Int Urogynecol J. 2010 Sep;21(9):1057-63. doi: 10.1007/s00192-010-1163-8. Epub 2010 Apr 29.

DOI:10.1007/s00192-010-1163-8
PMID:20428997
Abstract

INTRODUCTION AND HYPOTHESIS

This study seeks to compare the small intestine submucosa (SIS) graft with traditional colporrhaphy (TC) for surgical treatment of anterior vaginal prolapse.

METHODS

Subjects were randomly assigned to SIS (n = 29) or to TC (n = 27) preoperatively and outcomes analyzed at 12 months postoperatively. The primary outcome was the absence of POP-Q stage >or= II prolapse, and secondary outcome was improvement in quality of life. Data were compared with independent samples or paired Student's t test.

RESULTS

SIS group had 86.2% anatomic cure compared to 59.3% in TC (p = 0.03). SIS improved point Ba measurement significantly (-1.93 cm versus -1.37 cm, p = 0.02). Both operations significantly improved quality of life, although there were no differences between the groups. We observed a greater number of complications in the SIS group, with no infections or erosion.

CONCLUSIONS

SIS repair improved point Ba significantly. However, there were no differences observed in quality of life between the techniques.

摘要

引言与假设

本研究旨在比较小肠黏膜下层(SIS)移植术与传统阴道修补术(TC)治疗阴道前壁脱垂的效果。

方法

术前将受试者随机分为SIS组(n = 29)或TC组(n = 27),术后12个月分析结果。主要结局是无POP-Q分期≥II度脱垂,次要结局是生活质量改善。数据采用独立样本或配对t检验进行比较。

结果

SIS组的解剖学治愈率为86.2%,而TC组为59.3%(p = 0.03)。SIS组显著改善了Ba点测量值(-1.93 cm对-1.37 cm,p = 0.02)。两种手术均显著改善了生活质量,尽管两组之间无差异。我们观察到SIS组的并发症较多,但无感染或侵蚀。

结论

SIS修复术显著改善了Ba点。然而,两种技术在生活质量方面未观察到差异。

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Obstet Gynecol. 2008 Nov;112(5):1131-42. doi: 10.1097/AOG.0b013e3181898ba9.
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Changes in connective tissue in patients with pelvic organ prolapse--a review of the current literature.盆腔器官脱垂患者结缔组织的变化——当前文献综述
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Intense inflammatory reaction with porcine small intestine submucosa pubovaginal sling or tape for stress urinary incontinence.
植入式医疗设备的长期主动监测:对决定当前注册系统是否足以揭示安全性和有效性问题的因素的分析。
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Decellularization of Small Intestinal Submucosa.小肠黏膜下层脱细胞。
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Interface Focus. 2019 Aug 6;9(4):20190014. doi: 10.1098/rsfs.2019.0014. Epub 2019 Jun 14.
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A systematic review of outcome and outcome-measure reporting in randomised trials evaluating surgical interventions for anterior-compartment vaginal prolapse: a call to action to develop a core outcome set.一项关于评估前盆腔脏器脱垂手术干预的随机试验中结局及结局指标报告的系统评价:呼吁制定核心结局集。
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