The Efficacy and Safety of Radiation-Free Retrograde Intrarenal Surgery: A Prospective Multicenter-Based, Randomized, Controlled Trial.
J Urol
; 211(6): 735-742, 2024 Jun.
Article
em En
| MEDLINE
| ID: mdl-38721932
ABSTRACT
PURPOSE:
Fluoroscopy is usually required during retrograde intrarenal surgery (RIRS). Although fluoroscopy is considered necessary for effective and safe RIRS, there is growing awareness regarding radiation exposure risk to patients and surgeons. We conducted a multicenter-based, randomized, controlled trial to compare the safety and effectiveness of radiation-free (RF) RIRS with radiation-usage (RU) RIRS for kidney stone management. MATERIALS ANDMETHODS:
From August 2020 to April 2022, patients with a unilateral kidney stone (≤20 mm) eligible for RIRS were prospectively enrolled in 5 tertiary medical centers after randomization and divided into the RF and RU groups. RIRS was performed using a flexible ureteroscope with a holmiumYAG laser. The primary end point of this study was the success rate, defined as complete stone-free or residual fragments with asymptomatic kidney stones ≤ 3 mm. The secondary end point of this study was ascertaining the safety of RF RIRS. The success rates were analyzed using a noninferiority test.RESULTS:
Of the 140 consecutive randomized participants, 128 patients completed this study (RF 63; RU 65). The success rates (78% vs 80%, P = .8) were not significantly different between the groups. The rate of high-grade (grade 2-4) ureter injury was not significantly higher in the RF group compared to the RU group (RF = 3 [4.8%] vs RU = 2 [3.1%], P = .6). In RF RIRS, the success rate was noninferior compared to RU RIRS (the difference was 2.2% [95% CI, 0.16-0.12]).CONCLUSIONS:
This study demonstrated that the surgical outcomes of RF RIRS were noninferior to RU RIRS.Palavras-chave
Texto completo:
1
Bases de dados:
MEDLINE
Assunto principal:
Cálculos Renais
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Urol
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Coréia do Sul