Safety and Efficacy of Fluoroscopy-Free Technique During Retrograde Intrarenal Surgery for Renal Stones: A Prospective, Randomized, Controlled, Noninferiority Trial.
Abul-Fotouh Ahmed, Ahmed ElShazly, Abdullah Daoud, Hassan Abdelazim, Mohammed AlGammal
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引用次数: 0
Abstract
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.
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