Abul-Fotouh Ahmed, Ahmed ElShazly, Abdullah Daoud, Hassan Abdelazim, Mohammed AlGammal
{"title":"无透视技术在肾结石逆行肾内手术中的安全性和有效性:一项前瞻性、随机、对照、非劣效性试验。","authors":"Abul-Fotouh Ahmed, Ahmed ElShazly, Abdullah Daoud, Hassan Abdelazim, Mohammed AlGammal","doi":"10.1089/end.2025.0120","DOIUrl":null,"url":null,"abstract":"<p><p><b><i>Purpose:</i></b> Fluoroscopy-free (FF) retrograde intrarenal surgery (RIRS) presents a promising alternative to fluoroscopy-guided (FG) RIRS to reduce radiation exposure in endourology. This study aimed to assess the noninferiority of FF-RIRS compared with FG-RIRS regarding safety and efficacy. <b><i>Patients and Methods:</i></b> A prospective, randomized trial was conducted at a tertiary care center from November 2021 to June 2024. Adult patients with renal stones (10-30 mm) eligible for RIRS were randomized to either the FF-RIRS group (direct endoscopic visualization) or the FG-RIRS group. The primary endpoint was the stone-free rate (SFR), with secondary outcomes including stone size reduction, fluoroscopy use in FF-RIRS, operative time, hospital stay, reintervention, and complication rates. <b><i>Results:</i></b> The final analysis included 253 patients in the FF-RIRS group and 249 in the FG-RIRS group. The mean age was 41.3 ± 12.3 years, and the mean stone size was 16.5 ± 3.2 mm. In the FF-RIRS group, 214 procedures (84.6%) were performed without fluoroscopy, whereas 39 (15.4%) required fluoroscopy because of intraoperative challenges. Regression analysis identified multiple stones and congenital renal anomalies as predictors for fluoroscopy use. SFRs were comparable between groups (zero residual fragments [RF]: 54.9% vs. 51.0%, no RF >2 mm: 70.4% vs. 69.1%, no RF >4 mm: 79.4% vs. 82.3%) (<i>p</i> > 0.05). For SFR defined as no RF >4 mm, FF-RIRS demonstrated noninferiority with a -10% margin (p = 0.021). Furthermore, per-protocol analysis confirmed noninferiority (<i>p</i> = 0.002), with nearly equal SFRs (82.7% vs. 82.3%, <i>p</i> = 0.914). Stone size reduction, operative time, hospital stay, reintervention, and complication rates were similar between groups, with no serious adverse events. <b><i>Conclusions:</i></b> FF-RIRS is a safe and effective alternative to FG-RIRS for selected patients. Its safety and efficacy are noninferior to FG-RIRS in direct comparison. However, fluoroscopy should remain available as a backup, especially in complex cases, to ensure optimal outcomes and patient safety.</p>","PeriodicalId":15723,"journal":{"name":"Journal of endourology","volume":" ","pages":""},"PeriodicalIF":2.9000,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety and Efficacy of Fluoroscopy-Free Technique During Retrograde Intrarenal Surgery for Renal Stones: A Prospective, Randomized, Controlled, Noninferiority Trial.\",\"authors\":\"Abul-Fotouh Ahmed, Ahmed ElShazly, Abdullah Daoud, Hassan Abdelazim, Mohammed AlGammal\",\"doi\":\"10.1089/end.2025.0120\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b><i>Purpose:</i></b> Fluoroscopy-free (FF) retrograde intrarenal surgery (RIRS) presents a promising alternative to fluoroscopy-guided (FG) RIRS to reduce radiation exposure in endourology. This study aimed to assess the noninferiority of FF-RIRS compared with FG-RIRS regarding safety and efficacy. <b><i>Patients and Methods:</i></b> A prospective, randomized trial was conducted at a tertiary care center from November 2021 to June 2024. Adult patients with renal stones (10-30 mm) eligible for RIRS were randomized to either the FF-RIRS group (direct endoscopic visualization) or the FG-RIRS group. The primary endpoint was the stone-free rate (SFR), with secondary outcomes including stone size reduction, fluoroscopy use in FF-RIRS, operative time, hospital stay, reintervention, and complication rates. <b><i>Results:</i></b> The final analysis included 253 patients in the FF-RIRS group and 249 in the FG-RIRS group. The mean age was 41.3 ± 12.3 years, and the mean stone size was 16.5 ± 3.2 mm. In the FF-RIRS group, 214 procedures (84.6%) were performed without fluoroscopy, whereas 39 (15.4%) required fluoroscopy because of intraoperative challenges. Regression analysis identified multiple stones and congenital renal anomalies as predictors for fluoroscopy use. SFRs were comparable between groups (zero residual fragments [RF]: 54.9% vs. 51.0%, no RF >2 mm: 70.4% vs. 69.1%, no RF >4 mm: 79.4% vs. 82.3%) (<i>p</i> > 0.05). For SFR defined as no RF >4 mm, FF-RIRS demonstrated noninferiority with a -10% margin (p = 0.021). Furthermore, per-protocol analysis confirmed noninferiority (<i>p</i> = 0.002), with nearly equal SFRs (82.7% vs. 82.3%, <i>p</i> = 0.914). Stone size reduction, operative time, hospital stay, reintervention, and complication rates were similar between groups, with no serious adverse events. <b><i>Conclusions:</i></b> FF-RIRS is a safe and effective alternative to FG-RIRS for selected patients. Its safety and efficacy are noninferior to FG-RIRS in direct comparison. However, fluoroscopy should remain available as a backup, especially in complex cases, to ensure optimal outcomes and patient safety.</p>\",\"PeriodicalId\":15723,\"journal\":{\"name\":\"Journal of endourology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.9000,\"publicationDate\":\"2025-05-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of endourology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1089/end.2025.0120\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of endourology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1089/end.2025.0120","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
引用次数: 0
摘要
目的:无透视(FF)逆行肾内手术(RIRS)是一种有希望的替代透视引导(FG) RIRS,以减少放射暴露在泌尿外科。本研究旨在评估FF-RIRS与FG-RIRS在安全性和有效性方面的非劣效性。患者和方法:一项前瞻性随机试验于2021年11月至2024年6月在一家三级医疗中心进行。符合RIRS的成年肾结石(10-30毫米)患者被随机分为FF-RIRS组(直接内镜观察)或FG-RIRS组。主要终点是无结石率(SFR),次要终点包括结石大小减少、FF-RIRS中透视的使用、手术时间、住院时间、再干预和并发症发生率。结果:最终分析FF-RIRS组253例,FG-RIRS组249例。平均年龄41.3±12.3岁,平均结石大小16.5±3.2 mm。在FF-RIRS组中,214例(84.6%)手术无需透视,而39例(15.4%)手术由于术中挑战而需要透视。回归分析确定多发性结石和先天性肾异常是使用透视检查的预测因素。各组间的srr具有可比性(无残留碎片[RF]: 54.9% vs. 51.0%,无RF >2 mm: 70.4% vs. 69.1%,无RF >4 mm: 79.4% vs. 82.3%) (p > 0.05)。对于定义为无RF bb0 4 mm的SFR, FF-RIRS显示非劣效性,边际为-10% (p = 0.021)。此外,按方案分析证实非劣效性(p = 0.002), SFRs几乎相等(82.7% vs. 82.3%, p = 0.914)。两组间结石缩小、手术时间、住院时间、再干预和并发症发生率相似,无严重不良事件发生。结论:FF-RIRS是一种安全有效的替代FG-RIRS的方法。直接比较其安全性和有效性不逊于FG-RIRS。然而,为了确保最佳结果和患者安全,特别是在复杂病例中,透视检查仍应作为备用方法。
Safety and Efficacy of Fluoroscopy-Free Technique During Retrograde Intrarenal Surgery for Renal Stones: A Prospective, Randomized, Controlled, Noninferiority Trial.
Purpose: Fluoroscopy-free (FF) retrograde intrarenal surgery (RIRS) presents a promising alternative to fluoroscopy-guided (FG) RIRS to reduce radiation exposure in endourology. This study aimed to assess the noninferiority of FF-RIRS compared with FG-RIRS regarding safety and efficacy. Patients and Methods: A prospective, randomized trial was conducted at a tertiary care center from November 2021 to June 2024. Adult patients with renal stones (10-30 mm) eligible for RIRS were randomized to either the FF-RIRS group (direct endoscopic visualization) or the FG-RIRS group. The primary endpoint was the stone-free rate (SFR), with secondary outcomes including stone size reduction, fluoroscopy use in FF-RIRS, operative time, hospital stay, reintervention, and complication rates. Results: The final analysis included 253 patients in the FF-RIRS group and 249 in the FG-RIRS group. The mean age was 41.3 ± 12.3 years, and the mean stone size was 16.5 ± 3.2 mm. In the FF-RIRS group, 214 procedures (84.6%) were performed without fluoroscopy, whereas 39 (15.4%) required fluoroscopy because of intraoperative challenges. Regression analysis identified multiple stones and congenital renal anomalies as predictors for fluoroscopy use. SFRs were comparable between groups (zero residual fragments [RF]: 54.9% vs. 51.0%, no RF >2 mm: 70.4% vs. 69.1%, no RF >4 mm: 79.4% vs. 82.3%) (p > 0.05). For SFR defined as no RF >4 mm, FF-RIRS demonstrated noninferiority with a -10% margin (p = 0.021). Furthermore, per-protocol analysis confirmed noninferiority (p = 0.002), with nearly equal SFRs (82.7% vs. 82.3%, p = 0.914). Stone size reduction, operative time, hospital stay, reintervention, and complication rates were similar between groups, with no serious adverse events. Conclusions: FF-RIRS is a safe and effective alternative to FG-RIRS for selected patients. Its safety and efficacy are noninferior to FG-RIRS in direct comparison. However, fluoroscopy should remain available as a backup, especially in complex cases, to ensure optimal outcomes and patient safety.
期刊介绍:
Journal of Endourology, JE Case Reports, and Videourology are the leading peer-reviewed journal, case reports publication, and innovative videojournal companion covering all aspects of minimally invasive urology research, applications, and clinical outcomes.
The leading journal of minimally invasive urology for over 30 years, Journal of Endourology is the essential publication for practicing surgeons who want to keep up with the latest surgical technologies in endoscopic, laparoscopic, robotic, and image-guided procedures as they apply to benign and malignant diseases of the genitourinary tract. This flagship journal includes the companion videojournal Videourology™ with every subscription. While Journal of Endourology remains focused on publishing rigorously peer reviewed articles, Videourology accepts original videos containing material that has not been reported elsewhere, except in the form of an abstract or a conference presentation.
Journal of Endourology coverage includes:
The latest laparoscopic, robotic, endoscopic, and image-guided techniques for treating both benign and malignant conditions
Pioneering research articles
Controversial cases in endourology
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Endourology survey section of endourology relevant manuscripts published in other journals.