内镜下注射Vantris与Gil-Vernet手术治疗原发性膀胱输尿管反流(VUR)的比较

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Results: The Vantris group comprised 5 males and 26 females with the mean age of 6.15±2.26 years (range, 1-10) versus the Gil-Vernet that included 9 males and 21 females with the mean age of 5.23±2.05 years (range, 1-10) (p=0.20 and 0.21, respectively). The VUR grade decreased significantly in both groups after operation (p<0.001), but despite a better improvement in the Vantris patients the inter-group analysis missed a statistically significant level in a marginal fashion (p=0.07). The rate of improvement and full improvement was 98% and 81.6% in the Vantris group vs. 94% and 86% in the Gil-Vernet group, respectively (p=0.62 and 0.56, respectively). Conclusion: Although postoperative improvement in VUR grade was better in the Vantris® group than that in the Gil-Vernet group, the difference was not statistically significant. Both methods of treatment were safe and with a high rate of success. Nevertheless, lesser manipulations performed in Vantris® makes it favorable comparing with open Gil-Vernet method. Citation: Rashed FK, Roshandel MR, Aghaei Badr T, Motlagh RS. Comparison of Endoscopic Injection of Vantris and Gil-Vernet surgery in the Treatment of Primary Vesicoureteral Reflux (VUR). J Urol Nephrol. 2019;6(1): 5. J Urol Nephrol 6(1): 5 (2019) Page 02 ISSN: 2380-0585 malformation, including obstruction or full duplicated pielocalicial system, suspected or proven voiding dysfunction through clinical findings, including abnormal neurological examination or intestinal dysfunction or obstructive-stimulatory LUTS, confirmed by VCUG or sonographic evidence of irregular bladder wall or diverticulum or trabeculation, low bladder volume and neurogenic bladder. 61 patients (100 renal units) with Vesicoureteral reflux were included based on pre-determined inclusion and exclusion criteria, after proving their reflux and the disease grade by VCUG. After explaining the study terms and conditions, the children were categorized into one of the groups of Vantris endoscopic injection (Promedone, Cordoba, Argentina) or Gil-Vernet open surgery. All operations were done by a single attending pediatric urologist who was trained with more than 10 years of performing experience for endoscopic injection. In patients undergoing endoscopic injection (31 patients, 50 renalunits), the Vantris bulking material was sub mucosally injected through the compact cystoscope with 6-French size and 23-gauge needles under the intramural ureter at 6 o’clock position of the ureteral orifice (STING method). In patients with higher grades of reflux and very loose ureteral orifice, it was injected inside the ureter. Volume of injection varied from 0.2 to about 2 cc, depending on the patient. The patients were discharged the same day of surgery with oral antibiotics for a week. Finally, follow-up was not feasible on one renal unit because Left the trial after surgery and 49 renal units were investigated in this group. In the Gil-Vernet antireflux surgery group (30 patients, 50 renal units), patients underwent classic Gil-Vernet antireflux surgery. In this technique, in cases of unilateral reflux, both sides underwent surgery to prevent reflux in the opposite side due to trigone instability. These patients were discharged after two days. Patients had no Foley catheter after surgery and were discharged with antibiotics for one week. All patients underwent ultrasonography two weeks after surgery for hydronephrosis (as a complication). Three months postoperatively, VCUG (voiding cysto-ureterography) was performed to follow-up of reflux. The reporters of the VCUG images were unaware of the type of the treatment. Treatment success was defined as eliminating or reducing the severity of reflux. Statistical analysis The data was reported by mean±standard deviation, or standard error (if necessary), and frequency (%). Statistical software SPSSTM Variable Vantris (31 cases) Open surgery (30 cases) P Value*","PeriodicalId":17651,"journal":{"name":"Journal of Urology & Nephrology Studies","volume":"15 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2019-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Comparison of Endoscopic Injection of Vantris and Gil-Vernet surgery in the Treatment of Primary Vesicoureteral Reflux (VUR)\",\"authors\":\"\",\"doi\":\"10.13188/2380-0585.1000027\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Purpose: Vesicoureteral Reflux (VUR) is the most common urologic condition in pediatric population, affecting almost 1% of children. The present study aims to compare outcomes of an open surgical technique (Gil-Vernet), an old-fashioned method still performed in some centers, and the endoscopic correction using Vantris as a preferred less invasive method in children with VUR. Materials and methods: In this randomized clinical trial, a total of 61 children with VUR of grades I-IV underwent either open surgical repair using the Gil-Vernet approach (30 patients, 50 renal refluxing units), or endoscopic repair using Vantris as the bulking agent (31 patients, 49 renal refluxing units). The change in VUR grade before and after operation was compared between the two groups. Results: The Vantris group comprised 5 males and 26 females with the mean age of 6.15±2.26 years (range, 1-10) versus the Gil-Vernet that included 9 males and 21 females with the mean age of 5.23±2.05 years (range, 1-10) (p=0.20 and 0.21, respectively). 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In patients undergoing endoscopic injection (31 patients, 50 renalunits), the Vantris bulking material was sub mucosally injected through the compact cystoscope with 6-French size and 23-gauge needles under the intramural ureter at 6 o’clock position of the ureteral orifice (STING method). In patients with higher grades of reflux and very loose ureteral orifice, it was injected inside the ureter. Volume of injection varied from 0.2 to about 2 cc, depending on the patient. The patients were discharged the same day of surgery with oral antibiotics for a week. Finally, follow-up was not feasible on one renal unit because Left the trial after surgery and 49 renal units were investigated in this group. In the Gil-Vernet antireflux surgery group (30 patients, 50 renal units), patients underwent classic Gil-Vernet antireflux surgery. In this technique, in cases of unilateral reflux, both sides underwent surgery to prevent reflux in the opposite side due to trigone instability. 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引用次数: 1

摘要

目的:膀胱输尿管反流(VUR)是儿科人群中最常见的泌尿系统疾病,影响近1%的儿童。本研究旨在比较开放式手术技术(Gil-Vernet)的结果,这是一种仍在一些中心使用的老式方法,以及使用Vantris作为一种首选的微创方法对儿童VUR进行内镜矫正的结果。材料和方法:在这项随机临床试验中,共有61名I-IV级VUR儿童接受了Gil-Vernet入路的开放手术修复(30例患者,50个肾反流单位),或使用Vantris作为膨胀剂的内镜修复(31例患者,49个肾反流单位)。比较两组患者手术前后VUR分级的变化。结果:Vantris组男性5例,女性26例,平均年龄6.15±2.26岁(范围,1 ~ 10);Gil-Vernet组男性9例,女性21例,平均年龄5.23±2.05岁(范围,1 ~ 10)(p分别为0.20和0.21)。两组患者术后VUR评分均显著下降(p<0.001),但尽管Vantris组患者改善较好,但组间分析在边际方式上没有统计学显著水平(p=0.07)。Vantris组的改善率为98%,完全改善率为81.6%,Gil-Vernet组为94%,完全改善率为86%,差异有统计学意义(p=0.62, 0.56)。结论:虽然Vantris组术后VUR分级改善优于Gil-Vernet组,但差异无统计学意义。这两种治疗方法都是安全且成功率高的。然而,与开放式Gil-Vernet方法相比,在Vantris®中进行的较少操作使其具有优势。引用本文:Rashed FK, Roshandel MR, Aghaei Badr T, Motlagh RS。内镜下注射Vantris与Gil-Vernet手术治疗原发性膀胱输尿管反流(VUR)的比较。中华泌尿外科杂志,2019;6(1):5。中国泌尿外科杂志6(1):5 (2019)Page 02 ISSN: 2380-0585畸形,包括梗阻或完全重复的膀胱系统,通过临床表现怀疑或证实排尿功能障碍,包括异常神经学检查或肠功能障碍或梗阻性刺激LUTS,通过VCUG或超声证据证实膀胱壁不规则或憩室或小梁,膀胱体积小和神经源性膀胱。61例膀胱输尿管反流患者(100肾单位)经VCUG证实其反流和疾病分级后,根据预先确定的纳入和排除标准纳入。在解释研究条款和条件后,将儿童分为Vantris内窥镜注射组(Promedone, Cordoba,阿根廷)和Gil-Vernet开放手术组。所有手术均由一名儿科泌尿科医生完成,该医生接受过10年以上的内窥镜注射经验培训。在接受内镜注射的患者中(31例,50肾单位),在输尿管口6点钟位置,通过紧凑膀胱镜使用6- french尺寸和23号针头在输尿管内粘膜下注射Vantris填充材料(STING法)。对于反流程度较高且输尿管口非常疏松的患者,将其注入输尿管内。注射量从0.2到约2cc不等,取决于患者。患者于手术当天出院,口服抗生素治疗一周。最后,由于手术后退出试验,无法对一个肾单位进行随访,该组共调查了49个肾单位。在Gil-Vernet抗反流手术组(30例患者,50个肾单位),患者接受经典Gil-Vernet抗反流手术。在这种技术中,在单侧反流的情况下,双方都进行手术以防止由于三角区不稳定而导致对侧反流。这些患者在两天后出院。患者术后未置Foley导尿管,术后一周抗生素治疗出院。所有患者术后两周均行肾积水超声检查(作为并发症)。术后3个月行膀胱输尿管造影(VCUG)随访反流。VCUG图像的记者不知道治疗的类型。治疗成功的定义是消除或减轻反流的严重程度。统计分析数据以均数±标准差,或标准误差(如有必要)和频率(%)报告。统计软件SPSSTM Variable Vantris(31例)开放手术(30例)P值*
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Comparison of Endoscopic Injection of Vantris and Gil-Vernet surgery in the Treatment of Primary Vesicoureteral Reflux (VUR)
Purpose: Vesicoureteral Reflux (VUR) is the most common urologic condition in pediatric population, affecting almost 1% of children. The present study aims to compare outcomes of an open surgical technique (Gil-Vernet), an old-fashioned method still performed in some centers, and the endoscopic correction using Vantris as a preferred less invasive method in children with VUR. Materials and methods: In this randomized clinical trial, a total of 61 children with VUR of grades I-IV underwent either open surgical repair using the Gil-Vernet approach (30 patients, 50 renal refluxing units), or endoscopic repair using Vantris as the bulking agent (31 patients, 49 renal refluxing units). The change in VUR grade before and after operation was compared between the two groups. Results: The Vantris group comprised 5 males and 26 females with the mean age of 6.15±2.26 years (range, 1-10) versus the Gil-Vernet that included 9 males and 21 females with the mean age of 5.23±2.05 years (range, 1-10) (p=0.20 and 0.21, respectively). The VUR grade decreased significantly in both groups after operation (p<0.001), but despite a better improvement in the Vantris patients the inter-group analysis missed a statistically significant level in a marginal fashion (p=0.07). The rate of improvement and full improvement was 98% and 81.6% in the Vantris group vs. 94% and 86% in the Gil-Vernet group, respectively (p=0.62 and 0.56, respectively). Conclusion: Although postoperative improvement in VUR grade was better in the Vantris® group than that in the Gil-Vernet group, the difference was not statistically significant. Both methods of treatment were safe and with a high rate of success. Nevertheless, lesser manipulations performed in Vantris® makes it favorable comparing with open Gil-Vernet method. Citation: Rashed FK, Roshandel MR, Aghaei Badr T, Motlagh RS. Comparison of Endoscopic Injection of Vantris and Gil-Vernet surgery in the Treatment of Primary Vesicoureteral Reflux (VUR). J Urol Nephrol. 2019;6(1): 5. J Urol Nephrol 6(1): 5 (2019) Page 02 ISSN: 2380-0585 malformation, including obstruction or full duplicated pielocalicial system, suspected or proven voiding dysfunction through clinical findings, including abnormal neurological examination or intestinal dysfunction or obstructive-stimulatory LUTS, confirmed by VCUG or sonographic evidence of irregular bladder wall or diverticulum or trabeculation, low bladder volume and neurogenic bladder. 61 patients (100 renal units) with Vesicoureteral reflux were included based on pre-determined inclusion and exclusion criteria, after proving their reflux and the disease grade by VCUG. After explaining the study terms and conditions, the children were categorized into one of the groups of Vantris endoscopic injection (Promedone, Cordoba, Argentina) or Gil-Vernet open surgery. All operations were done by a single attending pediatric urologist who was trained with more than 10 years of performing experience for endoscopic injection. In patients undergoing endoscopic injection (31 patients, 50 renalunits), the Vantris bulking material was sub mucosally injected through the compact cystoscope with 6-French size and 23-gauge needles under the intramural ureter at 6 o’clock position of the ureteral orifice (STING method). In patients with higher grades of reflux and very loose ureteral orifice, it was injected inside the ureter. Volume of injection varied from 0.2 to about 2 cc, depending on the patient. The patients were discharged the same day of surgery with oral antibiotics for a week. Finally, follow-up was not feasible on one renal unit because Left the trial after surgery and 49 renal units were investigated in this group. In the Gil-Vernet antireflux surgery group (30 patients, 50 renal units), patients underwent classic Gil-Vernet antireflux surgery. In this technique, in cases of unilateral reflux, both sides underwent surgery to prevent reflux in the opposite side due to trigone instability. These patients were discharged after two days. Patients had no Foley catheter after surgery and were discharged with antibiotics for one week. All patients underwent ultrasonography two weeks after surgery for hydronephrosis (as a complication). Three months postoperatively, VCUG (voiding cysto-ureterography) was performed to follow-up of reflux. The reporters of the VCUG images were unaware of the type of the treatment. Treatment success was defined as eliminating or reducing the severity of reflux. Statistical analysis The data was reported by mean±standard deviation, or standard error (if necessary), and frequency (%). Statistical software SPSSTM Variable Vantris (31 cases) Open surgery (30 cases) P Value*
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