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腹腔镜与显微外科精索静脉曲张切除术治疗精索静脉曲张不育男性术后12个月受孕率的比较:一项前瞻性随机对照试验

The comparison of laparoscopic and microsurgical varicocoelectomy in infertile men with varicocoele on paternity rate 12 months after surgery: a prospective randomized controlled trial.

作者信息

Bryniarski P, Taborowski P, Rajwa P, Kaletka Z, Życzkowski M, Paradysz A

机构信息

Department of Urology, Medical University of Silesia in Katowice, Zabrze, Poland.

出版信息

Andrology. 2017 May;5(3):445-450. doi: 10.1111/andr.12343. Epub 2017 Mar 27.

DOI:10.1111/andr.12343
PMID:28346969
Abstract

The best surgical approach for varicocoelectomy is still unknown, however more and more physicians favour subinguinal microsurgery. The aim of this study was to find whether microsurgical approach is superior to laparoscopic varicocoelectomy in terms of pregnancy rate, fertility potential, endocrinological function of the testis, erectile dysfunction and testicle volume increase. It was a prospective, non-masked, parallel-group randomized controlled trial with one to one allocation. It was conducted at authors' institution and designed as per protocol study. From 2012 till 2015 84 patients were randomly allocated to two groups. First group consisted of 42 patients who underwent laparoscopic varicocoelectomy, whereas patients from the second group underwent microsurgical varicocoelectomy. The indications for varicocoelectomy consisted of infertility >1 year, palpable left-sided varicocoele and at least one impaired semen parameter (sperm concentration <15 mln/mL; total motility<40%; progressive motility <32%, vitality <58% or normal morphology <4%). The primary goal was to show superiority of microsurgical varicocoelectomy over laparoscopic varicocoelectomy in terms of pregnancy rate. The secondary endpoints comprised assessment of sperm parameters in three-month intervals after intervention until one year. Other points included, LH, FSH and testosterone levels as well as testicle volume and International Index of Erectile Function. From each group five patients were lost during the follow-up period. The primary endpoint was not achieved - pregnancy rate in first and second group was 29.7% and 40.5% respectively (p = 0.34). Analysis of the sperm parameters after surgery revealed significant statistical difference in total motility, progressive motility and morphology in favour of microsurgical approach. Both methods showed improvement in all sperm parameters. There were no differences in hormonal levels as well as in erectile function and testicle volume between groups. Small number of patients in both groups are the main limitation of our study.

摘要

精索静脉曲张切除术的最佳手术方式仍不明确,然而越来越多的医生倾向于腹股沟下显微手术。本研究的目的是探讨在妊娠率、生育潜能、睾丸内分泌功能、勃起功能障碍及睾丸体积增加方面,显微手术方式是否优于腹腔镜精索静脉曲张切除术。这是一项前瞻性、非盲法、平行组随机对照试验,采用一对一分配。研究在作者所在机构进行,按照方案研究设计。2012年至2015年,84例患者被随机分为两组。第一组42例患者接受腹腔镜精索静脉曲张切除术,而第二组患者接受显微精索静脉曲张切除术。精索静脉曲张切除术的适应症包括不孕超过1年、可触及的左侧精索静脉曲张以及至少一项精液参数受损(精子浓度<1500万/mL;总活力<40%;前向运动力<32%,活力<58%或正常形态<4%)。主要目标是证明显微精索静脉曲张切除术在妊娠率方面优于腹腔镜精索静脉曲张切除术。次要终点包括干预后直至1年期间每3个月对精子参数的评估。其他指标包括促黄体生成素(LH)、促卵泡生成素(FSH)和睾酮水平,以及睾丸体积和国际勃起功能指数。随访期间每组有5例患者失访。主要终点未达到——第一组和第二组的妊娠率分别为29.7%和40.5%(p = 0.34)。术后精子参数分析显示,总活力、前向运动力和形态学方面存在显著统计学差异,支持显微手术方式。两种方法均显示所有精子参数有所改善。两组之间激素水平、勃起功能和睾丸体积无差异。两组患者数量较少是本研究的主要局限性。

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