文献首发 | 经导管泡沫硬化剂注射与腹腔镜高位结扎术治疗左侧精索静脉曲张的疗效分析

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经导管泡沫硬化剂注射与腹腔镜高位结扎术治疗左侧精索静脉曲张的疗效分析

井业翔1 王瑞华2 刘兆轩2 孟庆义2

【1 山东第一医科大学(山东省医学科学院)2 山东第一医科大学附属中心医院血管外科】

摘要:

目的:精索静脉曲张是好发于中青年男性的常见疾病,可导致阴囊疼痛、肿胀和男性不育。目前的治疗方式包括外科手术治疗和介入治疗。我们的目的是比较左侧精索静脉曲张经导管逆行泡沫硬化剂注射治疗与腹腔镜高位结扎术的疗效。

材料与方法:自 2017 年 1 月至 2018 年 9 月我们回顾性治疗了 69 例精索静脉曲张患者,分为两组。A 组 26 例患者行硬化剂注射治疗;B 组43例患者行腹腔镜手术治疗。两组术后进行12个月的随访,包括电话联系、体格检查及多普勒超声检查。我们对两组患者的技术成功率、术后复发率、术后并发症发生率、手术时间、住院时间、治疗费用等进行分析。

结果与局限性:所有患者均顺利完成了手术,A 组 20 例患者术中一次硬化剂注射达到满意疗效,剩余 6 例患者于术中再次注入泡沫硬化剂后疗效满意;术后并发症发生率 19.2%、手术时间(31.1±11.1)min、住院时间(1.2±0.49)d、治疗费用(9613.11±895.97)元。B 组 43 例患者,其中 9 例患者行腹腔镜双侧精索静脉高位结扎术,剩余 35 例患者行单纯左侧治疗。术后左侧精索静脉曲张复发率 4.7%、并发症发生率 44.2%、手术时间(50.4±14.48)min、住院时间(4.0±2.02)d、治疗费用(10948.29±2547.00)元。硬化剂组在并发症发生率、手术时间、住院时间及治疗费用等方面均低于腹腔镜组,具有统计学差异(P<0.05)。组间比较复发率两种方法无统计学差异(P>0.05)。由于本中心患者大多数为尚未结婚的青年患者且大部分患者均因主观不适及查体发现前来就诊治疗,因此术前术后并未进行精液参数的检测。本研究的局限性还在于,它是来自于一个单中心、小样本的回顾性研究,此外,对于患者的随访也是有限的,且在随访过程中一些患者并未完全完成随访计划。

结论:与腹腔镜下精索静脉高位结扎术相比,经导管泡沫硬化剂注射治疗,避免了全身麻醉,在局部麻醉下进行治疗,临床及技术成功率高,复发率低且并发症少,患者恢复快,住院周期短,是一种安全有效、经济社会效益好,值得推广的手术方式。而腹腔镜手术在治疗双侧病变时具有优势。

关键词:

精索静脉曲张;泡沫硬化剂;栓塞;腹腔镜

精索静脉曲张是男科常见病之一,多见于青壮年,在普通男性中的发病率约为 8%~23%,在不育的患者中约为 40%[1]。它是一种血管病变,指精索内蔓状静脉丛的异常扩张、伸长和迂曲,睾丸周围的静脉充血及性腺静脉功能不全会导致阴囊内温度的升高,这些因素会导致睾丸缺氧及氧化应激,并且反流会导致肾脏及肾上腺的代谢产物到达阴囊,由于这些原因会导致阴囊疼痛、坠胀感、睾丸萎缩及进行性睾丸功能减退,是成年人不育的常见原因 [2,3]。精索静脉曲张以左侧发病多见,双侧及右侧发病少见,一般认为主要与以下因素有关:①左侧精索静脉较右侧长,右侧精索静脉直接汇入下腔静脉,而左侧精索静脉常呈直角汇入左侧肾静脉。②“胡桃夹”现象及左侧精索静脉下段位于乙状结肠后面,这些解剖特点易使精索静脉受压,导致静脉血液回流受阻。③左肾静脉入口处瓣膜功能不全。目前主要的治疗方式有外科手术治疗以及血管腔内治疗,外科手术方式分为:开放手术、腹腔镜手术及显微外科手术。自 1955 年以来,结扎手术一直是精索静脉曲张的主要治疗方式[4],而血管腔内治疗精索静脉曲张在 20 世纪 70 年代末首次被描述为一种治疗的选择[5]。随着介入技术的不断发展、栓塞材料的不断改善以及创伤小、恢复快的优点,经导管泡沫硬 化栓塞治疗精索静脉曲张已经成为一种越来越被关注与应用的手术方式。本中心自 2017 年 1 月至 2018 年 9 月共收治精索静脉张患者 69 例,其中 26 例行 DSA引导下经导管泡沫硬化剂注射,43 例行腹腔镜下精索静脉高位结扎术。本文回顾性比较了两种手术方式的在技术成功率、并发症、复发率、技术优势及相关经济、社会效益等方面的结果,现报告如下。

1

 资料与方法 

1.1 一般资料

将本中心自 2017 年 1 月至 2018 年 9 月收治精索静脉张患者分为两组,所有患者的评估均从体格检查开始,即在病人放松和 Valsalva 动作下对阴囊进行视诊与触诊并根据 Dubin等人[6]提出的临床分类方法进行分级:只有行 Valsalva 动作时才能触及到(Ⅰ级),看不到但在休息时可触及到(Ⅱ级),在休息既能触摸到也能看到(Ⅲ级)。接下来对所有患者行阴囊彩色多普勒超声检查,均诊断为精索静脉曲张。A 组 26 例为泡沫硬化剂组,B 组 43 例为腹腔镜组。其中 A 组均行精索静脉泡沫硬化剂注射治疗;Ⅰ级 2 人,Ⅱ级 8人,Ⅲ级16人;患者年龄 15~55(21.2±7.14)岁。B 组均行精索静脉高位结扎术;Ⅰ级 2 人,Ⅱ级 8,Ⅲ级33 人;年龄 17~59(32.7±13.1)岁(表 1)。治疗指征包括睾丸疼痛或不适、睾丸或腹股沟肿胀、睾丸不对称,预防性治疗以及患者自身的治疗意愿。

1.2 经导管泡沫硬化剂逆行注射治疗

1.2.1 泡沫硬化剂的制备 我中心均采用应用 1%聚桂醇注射液(Lauromacrogol Injection,化学名称聚氧乙烯月桂醇醚,国药准字 H20080445,陕西天宇制药有限公司),三通,10ml 无菌塑料注射器,应用 Tessari 法将两者按 1:4 的比例制成泡沫硬化剂[7],现配现用,防止泡沫硬化剂出现浓度降低失效的情况。

1.2.2 治疗经过 所有患者平躺于 DSA 手术床上,均在局麻下应用 Seldinger 技术穿刺右侧股静脉,穿刺成功后,引入 4F 血管鞘及 4F 猪尾巴导管,行下腔静脉造影:左侧肾静脉开口位于第一腰椎水平下缘。后于透视,在超滑泥鳅导丝引导下引入 4F Cobra 导管至下腔静脉,成功选入左侧肾静脉,并在导丝引导下超选入精索内静脉。在超选入精索内静脉有困难时,可先将导管置于肾静脉造影,以观察精索内静脉位置,判断有无解剖变异。后更换 4F 单弯导管定位于骶髂关节下缘(在骶髂关节下缘有更多侧支静脉起源时,将导管置于这些分支的水平,以便对所有的脉络进行广泛的硬化治疗),嘱患者行 Valsalva 动作,造影示:精索内静脉及其属支明显扩张、迂曲,瓣膜功能不全,对比剂明显反流,远端精索静脉丛对比剂滞留。精索静脉曲张诊断明确及确定精索静脉伴行分支后,配制泡沫硬化剂。再次嘱患者瞬时憋气,缓慢推注 6ml 泡沫硬化剂,注射完药物 10 分钟之后,再次采取静脉造影并嘱患者行Valsaval 动作观察反流情况,并根据反流情况决定是否再次注射硬化剂,仍有反流者可再次注入泡沫硬化剂 3ml。穿刺点给与加压包扎,嘱患者平卧 6 小时(图 1)。

a:将 4F 单弯导管定位于骶髂关节造影可见精索内静脉及其属支明显扩张、迂曲,瓣膜功能 不全,对比剂明显反流,远端精索静脉丛对比剂滞留。

b:在透视下将配置好的泡沫硬化剂注入曲张静脉。

c:10 分钟后再次造影是未见精索内静脉反流。

1.3 腹腔镜下精索静脉高位结扎术

1.3.1 手术经过 患者取平卧位,头低足高,行气管插管全麻。气腹压力13mmHg,于脐下缘置入 10mm Troca,分别于脐与左、右髂前上棘中点置入 5mm Troca。探查见左侧精索内静脉迂曲增粗,距左腹股沟内环口约 3cm 处剪开侧腹膜,游离精索内静脉,保护精索内动脉后,丝线双重结扎精索内静脉,于结扎线中间剪断精索内静脉。右侧手术同左侧。

1.4 观察指标

所有患者术后随访 12 个月,均通过家庭电话联系访谈及门诊进行体格检查、阴囊彩色多普勒超声复查,包括:(1)技术成功率;(2)术后随访 12 个月的复发率;(3)术后并发症发生率,如鞘膜积液、阴囊疼痛、睾丸萎缩、静脉炎、过敏反应等;(4)手术时间;(5)住院时间;(6)治疗费用。其中超声多普勒显示精索静脉有无反流为临床复发及治疗成功的标志(图 2)。

1.5 纳入及排除标准

纳入标准主要依据超声多普勒检测结果示精索内静脉反流,并根据体格检查对患者进行分级,次要标准即阴囊坠胀或疼痛等主观不适。患者有凝血障碍、既往行腹部手术或其他手术禁忌症者被排除在外。

1.6 统计学分析

应用 SPSS 统计软件对数据进行相应分析。

2

   结果   

2.1 基本情况

在这项回顾性研究中,所有患者均一次顺利完成了手术,A 组 20 例患者术中一次注入 6ml 泡沫硬化剂达到满意疗效,剩余 6 例患者于术中复造影发现仍有造影剂反流的情况后,再次补充 2ml 泡沫硬化剂达疗效满意。B 组 9 例患者行腹腔镜双侧精索静脉高位结扎术,剩余 35 例患者行单纯左侧治疗。两组患者均无深静脉血栓形成、肺动脉栓塞、卒中、血管破裂等严重并发症发生。

2.2 两组患者手术时间、住院时间及住院费用比较

硬化剂组平均手术时间为(31.1±11.1)min,较腹腔镜组(50.4±14.48)min 明显缩短(t=5.833,p<0.05);平均住院时间硬化剂组(1.2±0.49)d,较腹腔镜组(4.0±2.02)d 亦明显缩短(t=8.543,p<0.05);此外两者在平均费用方面硬化剂组(9613.11±895.97)元较腹腔镜组(10948.29±2547.00)元亦有统计学差异(t=3.131,p<0.05)(表 2)。

2.3 两组患者术后相关并发症情况比较

硬化剂组 1 例患者术后出现胸闷,给予吸氧等对症处理,观察 3 天症状消失后出院;1 例患者自述术后 1 周出现阴囊疼痛,考虑为泡沫硬化剂引起的静脉炎,给与口服活血化瘀及止痛药物,治疗半月后症状消失;1 例患者术后发现皮肤红疹伴瘙痒,考虑为过敏反应,给与口服抗过敏药物后症状消失;2 例患者术后随访中再次出现睾丸坠胀。所有患者未出现睾丸鞘膜积液及其它常见并发症。腹腔镜组患者在随访中有 10 例出现鞘膜积液;2 例出现阴囊疼痛;2 例于术中损伤睾丸动脉;2 例术后发生睾丸萎缩;3 例自述睾丸坠胀。硬化剂组在总体并发症发生率方面较腹腔镜组有优势,差异有统计学意义(X2=4.448,P<0.05)(表 3)。

3.4 随访结果

A 组随访中所有患者均未触及阴囊内曲张的静脉团,行超声多普勒检查示未见反流,未见复发情况。B 组有 2 例患者在分别随访至 6 个月及 9 个月时出现复发,复发率4.7%(2/43)。组间比较差异无统计学意义(X2=1.245,P>0.05)。

3

 讨论 

基础研究及临床观察发现,精索静脉曲张是一种进行性疾病,对于曲张的精索静脉进行手术干预能够消除患者的主观不适而且能够改善患者的精子活力、数量等相关指标,防止睾丸生精功能的进一步损伤。目前普遍接受的治疗指征包括:①精液分析异常;②患侧睾丸体积比对侧小 2ml 或 20%以上;③双侧 VC;④症状明显的 VC。但根据本研究中心纳入患者的情况来看,睾丸坠胀、疼痛、睾丸大小不对称以及外观的不满意仍是大部分中青年患者行手术治疗的首要原因。

与体格检查相比,多普勒超声比单纯体格检查有着更高的准确性,最被广泛接受的标准即在行 Valsalva 动作时精索内静脉直径>3.0-3.5mm[8]。精索静脉造影是诊断精索静脉曲张的金标准,但在大部分情况下,静脉造影只是在进行栓塞治疗时才会使用。据报道,反流持续至少 2 秒钟才相当于一个阳性结果[9]。行硬化剂治疗患者术前均常规进行静脉造影以明确诊断。其目的在于:①确认可触及的曲张静脉团以及那些体格检查未发现而又可疑的曲张静脉。②确认与精索静脉并行以及相互沟通的分支,从而确定硬化剂注射平面,进而更好的对分支静脉进行栓塞。

外科手术方式主要包括腹膜后精索静脉高位结扎术、显微镜下精索静脉结扎术、腹腔镜下精索静脉高位结扎术等。根据术式不同,治疗时间、治疗费用、并发症发生率及复发率各有不同[10]。据文献报道,显微镜下精索静脉结扎术是目前术后并发症发生率最的手术方式[11]。但该手术方式需要由丰富显微外科经验的医生来完成,手术时间明显高于介入治疗,并且同样存在损伤睾丸动脉的可能[12]。

目前经导管内硬化剂栓塞治疗精索静脉曲张作为一种新的治疗方式已被众多外科医生及患者广泛接受。支持这一观点的依据是其微创性,栓塞彻底,不需要全身麻醉,患者的耐受程度高,手术时间短,本组患者平均手术时间 31.1min,远低于平均手术时间 50.4min 的腹腔镜组。恢复快,术后 6 小时即可下地活动,术后 1 天即可出院。患者能够尽早恢复正常的工作、学习与生活。并且与传统的手术及腹腔镜手术相比有着更低的并发症发生率[13]。

经皮硬化剂注射治疗精索静脉曲张能够使静脉管壁发生炎症反应,静脉萎陷,肉芽组织而后纤维化在萎陷的静脉腔内生长,最终形成纤维条索使静脉腔永久性闭塞,达到使曲张静脉萎陷治疗的目的。泡沫硬化剂的空泡特性能够使硬化剂与静脉血管壁有着更大的接触表面积,浓度保持稳定,作用速度快,能够对血管壁产生更好的化学反应。此外泡沫硬化剂产品的液体性质允许扩散通过精索内静脉,进入并行静脉及一些细小的分支静脉因而能更好的发挥硬化栓塞的作用。

在技术成功率来说,由于解剖异常、静脉痉挛或技术困难,会有一部分病例在手术过程中导管难以超选入精索静脉或因为其它原因导致手术的失败。据文献报道经皮硬化过程的技术失败率从 5%到 20%不等[14,15,16]。本组患者均成功超选入左侧精索内静脉并成功施行硬化栓塞治疗,成功率 100%,高于相关文献报道,这很可能是本组样本量过小的原因。6 例患者于术中复造影发现仍有造影剂反流,再次补充 2ml 泡沫硬化剂达疗效满意。并未采取弹簧圈栓塞辅助治疗。也有许多研究人员指出,如果硬化剂注射后持续出现反流,则必须辅以弹簧圈完成治疗[17,18],目前还没有具体相关疗效的对比。

硬化剂栓塞治疗的主要并发症有血管损伤、血栓性静脉炎、对造影剂的过敏反应、硬化剂异位栓塞。在本组研究中有 1 例患者出现血栓性静脉炎,表现为睾丸轻度疼痛,给与口服抗炎、止痛及活血化瘀等药物对症治疗后好转。笔者分析,在注射硬化剂时,尽量避免过多的硬化剂进入阴囊,能够减少血栓性静脉炎的发生,减轻术后患者的不适。Motta A 等人[19]采用在阴囊上部行止血带结扎的方式来阻止可能反流入阴囊内的泡沫硬化剂,以此减轻术后患者出现静脉炎及阴囊疼痛的可能,这是值得我们借鉴的地方。此外,由于泡沫硬化剂中没有加入造影剂,我们不能完全排除硬化剂回流到肾静脉的可能性,或者出现异位栓塞。硬化剂组中有 1 例患者术后出现轻度胸闷,后自行缓解,未给与其它特殊处理,笔者分析还是出现了少量硬化剂异位栓塞的情况。针对减小硬化剂异位栓塞的概率,有部分研究中心将诊断导管更换为球囊导管进行泡沫硬化剂的注射,对比发现经球囊导管而不是通过诊断导管注射硬化剂似乎更能实现曲张静脉的完全栓塞以及在控制硬化剂方面更有优势[20]。

与腹腔镜手术相比,该技术的优点在于完全腔内治疗的特性,完整的淋巴管保留,同时避免了对睾丸动脉及精索的损伤,这是其他手术治疗不可避免的。对于淋巴管系统的保护,使发生阴囊水肿及鞘膜积液的可能性大大降低,同时淋巴管结扎被认为是导致睾丸功能明显降低的一个重要原因[21]。睾丸鞘膜积液是外科手术中常见的术后并发症(传统腹股沟精索静脉高位结扎 10%[22],腹腔镜下高位结扎 6%[23],栓塞技术几乎不会发生[24])。本研究腹腔镜组术后出现鞘膜积液比率为 23.3%,高于相关文献报道。

阻断精索内静脉及已存在的侧枝静脉反流入精索静脉丛是治疗精索静脉曲张的最终目标。无论是手术还是介入栓塞治疗精索静脉曲张,导致其失败以及复发的原因多是由于不能够消除掉来自腹部、盆腔等其它部位供应精索静脉的侧枝。这些侧枝与精索静脉沟通的部位多位于精索内静脉的起始部与腹股沟管深环之间[25]。此外 19%的精索静脉曲张患者有异常的解剖情况[26],这些解剖变异是腹腔镜及手术入路难以完全发现的。硬化治疗相对于腹腔镜高位结扎术最根本的优势在于,在整个手术过程中静脉造影是连续的,这可以获得清晰的曲张静脉血管图像指导手术的进行,因此能够选择性地栓塞掉几乎所有的交通、侧枝静脉亦或解剖变异的静脉,而这些静脉通常是导致精索静脉曲张复发最重要原因。本研究中硬化剂组所有患者随访期间并未出现精索静脉曲张复发的情况,腹腔镜组共有 2 名患者术后出现复发的情况,分别为术后 6 个月及 9 个月时发现,这两名患者均是单侧精索静脉曲张行腹腔镜治疗。

根据相关文献报道,Ollandini G,Liguori G,Ziaran S 等人[27]所做的比较开放手术、腹腔镜手术及经皮逆行硬化栓塞治疗精索静脉曲张对精子参数的影响实验发现,精索静脉曲张矫正手术对改善精子参数有帮助,与其研究方法相比,硬化技术能更好地改善精子质量。此外,许多其他的研究主要集中在治疗费用和恢复时间上:很多研究的手术费用都是相近的,但硬化技术治疗的患者住院及恢复时间明显更短。Feneley 等人[28]报告说,接受手术的患者需要2~3 周的恢复时间,而栓塞治疗仅需要 2 天即可完全恢复。正因为如此,Bechara 等人[14]得出结论,与外科治疗相比,放射辅助治疗更具有成本效益。因此,硬化剂治疗精索静脉曲张的经济及社会效益也是不容忽视,相比于腹腔镜手术,住院治疗费用的降低、住院天数的减少以及病人在工作中缺勤天数的减少都是具有优势的。

4

 结论 

我们总结了我们的经验,在多个方面对硬化剂栓塞与腹腔镜高位结扎术进行了比较,并介绍了使用聚桂醇泡沫硬化剂治疗精索静脉曲张的技术。可以肯定的是,经导管泡沫硬化剂治疗精索静曲张与腹腔镜手术相比,避免了全身麻醉,在局部麻醉下进行治疗,临床及技术成功率高,复发率低且并发症少,患者恢复快,住院周期短,满意度高,经济及社会效益好。其本质优势在于泡沫硬化剂能够选择性的栓塞掉精索内静脉的交通及侧枝静脉且不损伤伴行的动脉及淋巴管,而这往往是腹腔镜术后复发及出现鞘膜积液的最根本原因。因此该手术方式栓塞更加彻底且安全有效,是一种值得推广的手术方式。值得注意的是,本研究的局限性在于,它是来自于一个单中心、小样本的回顾性研究,此外,对于患者的随访也是有限的,且在随访过程中一些患者并未完全完成随访计划。

英文对照版

Analysis of internal spermatic vein embolization through catheter versus laparoscopic high ligation in treatment of left varicocele

Ye-Xiang Jing1 , Rui-Hua Wang2 , Zhao-Xuan Liu2 and Qing-Yi Meng2

【1 Department of Graduate School, Shandong First Medical University & Shandong Academy of Medical Sciences, Taian, China 2 Department of Vascular Surgery, Central Hospital Affiliated to Shandong First Medical University, Jinan, China】

Abstract:

Objective:Varicocele is a common disease in young and middle-aged men. This study aims to compare the efficacy of internal spermatic vein embolization of left varicocele versus laparoscopic high ligation.

Methods:From January 2017 to September 2018, a total of 69 varicocele patients were admitted and given the opportunity to choose the treatment option. Among these, 26 patients were treated with sclerosing agent injection, while 43 patients underwent laparoscopic surgery. They were followed up for 12 months after surgery, and the technical success rate, recurrence rate, complication rate, cost, operative time, and hospitalization time with regard to these two methods were analyzed.

Results:All patients completed the medical procedures. There was no recurrence in patients in the sclerotherapy group during the follow-up period; however, the complication rate was 19.2%. Furthermore, the operative time, hos±pitalization time, and cost of treatment were 31.1 ± 11.1 min, 1.2 ± 0.49 days, and 9613.11 ± 895.97 Yuan, respectively. In the laparoscopic group, 9 patients underwent laparoscopic bilateral high ligation, while 34 patients received treatment on the left side alone. The recurrence rate of left varicocele was 4.7% and the complication rate was 44.2%. Furthermore, the operative time, hospitalization time, and treatment cost were 50.4 ± 14.48 min, 4.0 ± 2.02 days, and 10,948.29 ± 2547.00 Yuan, respectively. Moreover, there were statistically significant differences (P<0.05) in operative time, hospitalization time, and treatment cost. Patients in the sclerotherapy group had an advantage with respect to the overall complication rate when compared with patients from the laparoscopic group (X2¼ 4.448, P < 0.05), and there was a statistically significant difference in hydrocele (X2 ¼ 4.555, P < 0.05). However, there was no significant difference in the recurrence rate between these two groups (X2¼ 1.245, P > 0.05).

Conclusion:Patients who underwent sclerotherapy showed a higher technical success rate, a lower recurrence rate, fewer complications, and shorter hospitalization time compared to those treated with laparoscopic ligation. Transcatheter sclerosing agent injection may be a preferable treatment option for patients with unilateral varicocele.

Keywords:

Varicocele, foam sclerosing agent, embolization, laparoscopic surgery

Varicocele is one of the most common diseases in young and middle-aged men. The incidence of vari-cocele is approximately 8%–23% in men, and approximately 40% in infertile patients.1 It is a vas-cular lesion that refers to abnormalities of the sper-matic plexus in expansion, elongation, circuity, testicular venous insuffificiency, and venous hyper-emia. These factors subsequently lead to testicularhypoxia, oxidative stress, and reverse flflows that transfer renal and adrenal metabolites to the scro-tum. This can cause scrotal pain, abdominal pain, atrophy, and progressive testicular function decline, which is a common reason for infertility in adults.2,3 Varicocele is more common on the left side due the following factors: (1) the left side of the spermatic vein is longer than the right side, the right side is directly connected to the inferior vena cava, and the left side of the spermatic vein often presents in a right angle to the left side of the renal vein; (2) the “nutcracker” phenomenon; the lower part of the left spermatic vein is located behind the sigmoid colon, which can easily lead to venous blood obstruction; and (3) the valve function at the entrance of the left renal vein is incomplete.

At present, the main methods include surgical and endovascular treatment. The surgical methods include open surgery, laparoscopic surgery, and microsurgery. Since 1955, ligation has been the main treatment for varicocele,4 while the endovascular treatment of vari-cocele was fifirst described as an option in the late 1970s.5 With the development of interventional tech-niques, improvement of embolization materials, advantages of small trauma, and rapid recovery, transcatheter foam sclerosing agent embolization has become an increasingly concerned and applied surgi-cal method.

In the present study, we retrospectively compared the technical success rate, complication rate, recurrence rate, operative time, hospitalization time, and fifinancial burden with respect to patients who received internal spermatic vein embolization and patients who were treated with laparoscopic high ligation.

 Materials and methods 

General materials

A total of 69 varicocele patients who were admitted to our hospital between January 2017 and September 2018 were included in the study. Patients admitted to the Department of Vascular Surgery received internal spermatic vein embolization (sclerotherapy group, n ¼ 26), whereas patients admitted to the Department of Urology underwent laparoscopic high ligation (lap-aroscopic group, n ¼ 43). All patients were given the opportunity to choose the department to be admitted to and the treatment option. The evaluation of patients began with their physical examination; visual examina-tion and palpation were performed on the scrotum using patient relaxation techniques and the Valsalva maneuver. The classifification was proposed by Dubin and Amelar6 as follows: palpable only by Valsalva maneuver (grade I); palpable at rest, but not visible (grade II); and visible and palpable at rest (grade III). Then, all patients underwent scrotal color Doppler ultrasonography and were diagnosed with varicocele. The age of patients in the sclerotherapy group ranged between 15 and 55 years (28.2 ± 11.7 years), while the age of patients in the laparoscopic group ranged between 17 and 60 years (32.8 ± 13.5 years) (Table 1). The treatment indications included testicular pain, dis-comfort, asymmetry, testicular or inguinal swelling, and prophylactic treatment; the patient’s willingness to be treated was also taken into consideration. Since most of the patients were young and unmarried and most of them asked for treatment due to subjective discomfort and physical examination fifindings, the semen parameters were not tested before and after surgery.

Internal spermatic vein embolization via catheter

Preparation of the foam sclerosing agent. At the medical center, 1% lauromacrogol (Tianyu Pharmaceutical Co. Ltd, Shanxi, China) injection, a three-way syringe, and 10-ml sterile plastic syringe were used to prepare the foam sclerosing agent in the ratio of 1:4 using the Tessari method7 in order to prevent it from losing its effectiveness due to decrease in concentration.

Treatment procedure. All patients were laid on a digital subtraction angiography operating table, and the right femoral vein was punctured using the Seldinger technique under local anesthesia. Then, a 4F vascular sheath and a 4F pigtail catheter were introduced to perform the inferior vena cava angiography; the left renal vein opening was located at the lower margin of the fifirst lumbar level. Under flfluoroscopy, a 4F Cobra catheter was introduced into the inferior vena cava with the help of a guide wire, which was successfully placed into the left renal vein, and subsequently into the internal spermatic vein. When it was diffificult to enter into the internal spermatic vein, the catheter was placed in the renal vein to fifirst perform the angi-ography and observe the position of the internal sper-matic vein, and then determine whether an anatomic variation is present. Next, the position of the 4F single-curved duct, which was on the edge of the sacroiliac joint, was changed (additional collateral veins originat-ed from the edge of on the edge of the sacroiliac joint, and hence, the catheter was placed at the level of these branches, allowing all the collateral veins to be treated). In the case of patients who underwent the Valsalva maneuver and imaging, the internal sper-matic vein and its branch expansion, circuity, valvular.insuffificiency, and contrast reflflux were stranded on the distal spermatic vein plexus. The foam sclerosing agent was prepared after the diagnosis of varicocele and its branches, and 6 ml of sclerosing agent was slowly injected under the Valsalva maneuver. Ten minutes after administering the injection, the patient underwent intravenous angiography again and was instructed to perform the Valsalva maneuver to observe the reflflux. For patients who still had a reflflux, 2 ml of foam scle-rosing agent was injected again. The puncture point was pressurized and bandaged, and the patient was instructed to lie down for 6 h (Figure 1).

Ten minutes after the fifirst injection of 6-ml foam sclerosing agent, which was the time window for the foam sclerosing agent to fully act, another angiography was performed through the catheter to determine whether there was still reflflux in the spermatic vein. If there was no reflflux, it indicated that the embolism was complete. The sclerosing agent embolization was performed by experienced operators.

These were the objective angiographic endpoints.

Laparoscopic high ligation

Treatment procedure. The patient was placed in a supine position and general anesthesia was administered. The pressure for the pneumoperitoneum was set at 13 mmHg; a 10-mm trocar was placed in the lower margin of the umbilicus, and 5-mm trocars were placed at the middle point of the umbilicus and at the left and right anterior superior iliac spine. The explo-ration revealed that the left internal spermatic vein had vascular tortuosity. Then, the side peritoneum was cut at approximately 3 cm from the inner ring of the left groin, allowing the internal spermatic vein to be free to protect the internal spermatic artery. Afterwards, the internal spermatic vein was ligated with a double silk thread and cut off in the middle of the ligation line. The procedure performed on the right side was the same as the procedure performed on the left side. The laparo-scopic high ligation was performed by experienced operators.

Observation

All patients were followed up for 12 months after surgery through telephone calls and outpatient appoint-ments, and physical examination and scrotal color Doppler ultrasonography were carried out. The following information was gathered: (1) technical success rate; (2) recurrence rate after the 12-month follow-up; (3) incidence of complications, such as hydrocele, scrotal pain, testicular atrophy, phlebitis, allergic reaction, etc.; (4) operative time; (5) length of hospital stay; and (6) treatment costs. The presence of reflflux observed through Doppler ultrasonography suggested clinical recurrence, while the absence of reflflux indicated successful treatment (Figure 2). The technical success in the sclerotherapy group was defifined as complete embo-lization of the spermatic vein below the sacroiliac joint level, with no contrast agent reflflux. The technical suc-cess with respect to the laparoscopic technique was defifined as successful ligation of the left spermatic vein. Postoperative recurrence was defifined as the redis-covery of varicose veins in the scrotum observed by scrotum Doppler ultrasound during the follow-up period. The complications caused by sclerosing agent injection are described in the European Guidelines for Sclerotherapy in Chronic Venous Disorders (2014).8 Complications that are unique to the treatment of var-icocele, such as hydrocele and injury to the testicular artery during surgery, were also included.9,10

Inclusion and exclusion criteria

The inclusion criteria were mainly based on the results of the Doppler ultrasonography, which indicated the internal spermatic vein reflflux, and the patients were graded according to their physical examination. The secondary criterion was subjective discomfort, such as pain or discomfort in the abdomen or the scro-tum. Patients with clotting disorders, abdominal sur-gery, or other contraindications were excluded.

Statistical analysis

SPSS 20.0 statistical software was used to analyze the data. In order to compare the clinical features of these two groups, t-test was used for continuous variables, while Chi-square test was used for categorical varia-bles. Count data were expressed by the rate, while mea±surement data were expressed as mean ± standard deviation. A P-value < 0.05 was considered statistically signifificant.

   Results   

Basic situation

In the present retrospective study, no signifificant differ-ence was observed regarding the baseline characteris-tics shown in Table 1. All patients successfully completed the procedures. In the sclerotherapy group, 20 patients achieved a satisfactory effect from injecting 6 ml of sclerosing agent only once, while the remaining 6 patients were successfully treated after injecting 2 ml of sclerosing agent again during the operation. In the laparoscopic group, 9 patients underwent bilateral lap-aroscopic high ligation, while the remaining 34 patients received treatment on the left side alone. No serious complications occurred in these two groups, such as deep venous thrombosis, pulmonary embolism, stroke, or vessel rupture.

Comparison of operative time, hospitalization time, and cost

The mean operative time for patients in the sclerother±apy group was 31.1 ± 11.1 min, which was signifificantly shorter when compared to the laparoscopic group (50.4 ± 14.48 min) (t ¼ 5.833, P < 0.05). The mean hos-pitalization time was also signifificantly shorter in the sclerotherapy group (1.2 ± 0.49 days) when compared to the laparoscopic group (4.0 ± 2.02 days) (t ¼ 8.543, P < 0.05). In addition, there was a statistically signififi- cant difference in the average cost between the sclerotherapy group and the laparoscopic group (9613.11 ± 895.97 Yuan and 10,948.29 ± 2547.00 Yuan, respectively) (t ¼ 3.131, P < 0.05); the costs were lesser in the sclerotherapy group (Table 2).

Comparison of complications

One patient in the sclerotherapy group developed chest tightness after surgery and was given symptomatic treatment, including oxygen inhalation. These symp-toms were observed for three days prior to discharge. At one week after surgery, one patient reported scrotal pain; phlebitis caused by the foam sclerosing agent was considered to be the cause. The patient was given oral analgesic drugs to activate blood circulation and remove the blood stasis, and the symptoms disap-peared after 14 days of treatment. Furthermore, skin rash with pruritus was observed in two patients, which was considered to be an allergic reaction of the contrast. This symptom disappeared after administer-ing oral anti-allergic drugs. One patient had hydrocele during the follow-up period, but no other common complications occurred.

Ten patients in the laparoscopic group presented with hydrocele. Scrotal pain occurred in three cases, and this was attributed to pulling of the spermatic cord during surgery. The testicular artery was injured in four cases, and testicular atrophy occurred in two cases after the operation.

Compared with the laparoscopic group, the sclerotherapy group had an advantage in regard to the over-all incidence of complications (X2¼ 4.448, P < 0.05), and there was a statistically signifificant difference in hydrocele (X2¼4.555, P < 0.05) (Table 3).

Follow-up results

During the follow-up with respect to the sclerotherapy group, the ultrasound Doppler examination revealed no reflflux or recurrence. In the laparoscopic group, two patients had recurrence at six and nine months of follow-up, with a recurrence rate of 4.7% (2/43). There was no signifificant difference between these two groups (X2¼1.245, P > 0.05).

 Discussion 

Varicocele is a common disease seen in adult males the commonly accepted treatment indications include: (1) abnormal semen analysis; (2) volume of the affected side observed to be 2 ml, or over 20% less than that of the normal side; (3) bilateral varicocele; and (4) obvi-ous symptoms of varicocele. In this study, however, complaints of testicular swelling and pain and unsatisfactory or asymmetrical testicular appearance were the primary reasons for surgical treatment as most of the recruited patients were young or middle-aged adults.

Doppler ultrasonography has been considered to be a reliable method for the diagnosis of varicoceles and the selection of treatment plan in varicocele patients.11 The most widely accepted standard is >3.0–3.5 mm diameter of the internal spermatic vein observed during the Valsalva maneuver.12 In this study, all patients were diagnosed with varicocele using scrotal color Doppler ultrasonography. Patients treated with sclerosing agent also underwent routine intravenous angiography before the operation in order to identify the accessible varicose veins and confifirm the parallel with the spermatic vein and the branches of the communication. Retrograde foam sclerosing agent embolization through a catheter is a widely accepted treatment method for varicocele with the following advantages: (1) minimal invasiveness; (2) complete embolization; (3) no need of general anesthesia; (4) high compliance of patients; and (5) short operation time. Here, we reported that the average operative time in the sclerotherapy group was 31.1 min, which was much shorter than that in the laparoscopic group (50.4 min). Paradiso et al.13 showed that Tauber’s antegrade sclerotherapy was a simple and feasible technique to treat all kinds of varicocele with low complication, recur-rence, and persistence rates. However, the procedure is often performed as open surgery and is carried out in the case of treatment of multiple varicose veins. Hence, it is not as microinvasive as retrograde sclerotherapy. The technical failure rate of percutaneous sclerosis ranges between 5% and 20% due to anatomical abnor-malities, venous spasm, or technical diffificulties.5,14,15 Moreover, sometimes it may be diffificult to place the catheter into the spermatic vein during the operation. However, for all the patients in this study, catheters were successfully placed into the left internal spermatic vein, and patients underwent sclerotherapy with a suc-cess rate of 100%, which was higher than previously reported. These results were probably attributable to the small sample size of this cohort. The main complications of sclerosing agent emboli-zation include vascular injury, thrombophlebitis, aller-gic reaction, and ectopic embolization. In the sclerotherapy group, one patient developed thrombo-phlebitis and presented with testicular pain. Previous evidence suggested that the prevention of excessive application of sclerosing agents into the scrotum might reduce the possibility of thrombophlebitis and patient discomfort. Motta et al.16 used tourniquet liga-tion on the upper part of the scrotum to prevent the sclerosing agent from possibly flflowing back into the scrotum, reducing the possibility of phlebitis and scro-tal pain in patients. As no contrast agent was added to the sclerosing agent during surgery, the possibility of the occurrence of abnormal embolization could not be completely ruled out. Another patient in the sclerother-apy group presented with mild chest tightness after the operation, which resolved spontaneously after surgery. A small amount of sclerosing agent ectopic emboliza-tion was also observed, which suggested that injecting the sclerosing agent through a balloon catheter might lead to a more complete embolization, with more advantages in controlling the sclerosing agent.17 Previous data have shown that sclerosing agent injec-tion resulted in lower incidence of complications com-pared to traditional surgery and laparoscopy.18 Lymphatic ligation is considered to be an important reason for testicular function decline.19 Moreover, hydrocele is a common complication in surgical oper-ations (10% for traditional high ligation,10 6% for lap-aroscopy,20 and rare occurrence for embolization21). The risk of scrotal edema and hydrocele can be greatly reduced by protecting the lymphatic system. In this study, only one case exhibited hydrocele in the sclero-therapy group compared to 23.3% of the cases in the laparoscopic group, probably due to patient age, anat-omy, and operations being performed by different sur-geons. Most varicocele recurrences and postoperative hydrocele formations are observed in patients with more than 12 months of follow-up.22 Hence, appropri-ate length of postoperative surveillance is deemed nec-essary for all patients.

The ultimate goal of treatment is to block the flfluid from the internal spermatic and existing collateral veins from flflowing back into the spermatic venous plexus. The failure and recurrence of varicocele is mostly seen due to the inability to eliminate the collateral supply from the abdomen, pelvis, or other parts. These branches communicate with the spermatic vein mostly between the initial part of the internal spermatic vein and the deep inguinal ring.23 Moreover, 19% of patients have abnormal anatomical conditions,24 which are diffificult to detect by laparoscopy and surgical approaches. In the present study, there was no recurrence in any patient in the sclerotherapy group during the follow-up period. In contrast, two patients in the laparoscopic group experienced a recurrence, one at six months and one at nine months after surgery.

Patients treated with sclerotherapy also showed rapid recovery (being able to get out of bed six hours post operation and being discharged one day post oper-ation).18 Feneley et al.25 reported that patients who underwent surgery needed two to three weeks of recov-ery, while patients who received embolization therapy merely needed two days to fully recover. Consistent with previous studies, the hospitalization time for patients in the sclerotherapy group (1.2 ± 0.49 days) was signifificantly shorter compared to the hospitaliza-tion time for patients in the laparoscopy group (4.0 ± 2.02 days)

The fifinancial burden of varicocele treatments should also be considered. Bechara et al.14 reported that radio-therapy was more cost-effective than surgery. However, there is some concern among people about the effects of radiation during surgery. According to Malekzadeh et al.,26 the radiation dosage in this operation was within the safe range. However, as many patients had a fear of radiation, especially patients with infertility, a lead plate was used to protect the genitals during the operation. Furthermore, we showed that the average cost for the sclerotherapy group was signifificantly lower than that for the laparoscopic high ligation group (9613.11 Yuan vs. 10,948.29 Yuan).

There are certain limitations of this study. This study was conducted at a single center and retrospec-tively compared the two methods in a small group of patients. Further investigations involving multiple cen-ters will be needed to ascertain the superiority of trans-catheter sclerosing agent injection in varicocele patients. In addition, a longer follow-up period will be needed to further validate the effificacy and safety of the sclerosing agent injection method. Other param-eters such as the quality, concentration, and mortality of sperm may also be assessed. Moreover, patients enrolled in this retrospective study were given the opportunity to choose their treatment plans, which may have introduced bias into the analyses.

 Conclusion 

This retrospective study compared the effificacy and out-comes of sclerosing agent embolization and laparo-scopic high ligation for varicocele patients. The use of lauromacrogol foam sclerosing agent for the treatment of varicocele was also introduced. According to our results, patients treated with sclerosing agent injection showed higher technical success rate, lower recurrence rate, fewer complications and shorter hospitalization time, and also had a lesser fifinancial burden compared to patients who underwent laparoscopy. Moreover, sclerotherapy does not require general anesthesia, which is another advantage of this method. Foam scle-rosing agent has been shown to selectively block the circulation of the internal spermatic vein without dam-aging the accompanying arteries and lymphatic vessels, which is the most fundamental cause of recurrence and hydrocele after laparoscopy. Thus, transcatheter scle-rosing agent injection may be a preferable treatment option for patients with unilateral varicocele.

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