Zhu, Wei and Chai, Chu Ann and Ma, Jinxiang and Gokce, Mehmet Ilker and Gadzhiev, Nariman and Kalathia, Jaisukh and Jiang, Kehua and Duan, Xianzhong and Cao, Jianwei and Wu, Rongpei and Song, Rijin and Bai, Song and Li, Xuedong and Liu, Shusheng and Zeng, Guohua (2024) Flexible Ureteroscopy with a Tip-bendable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy for Treatment of 2-3-cm Renal Stones: Study Protocol for an International, Multicenter, Randomized, Parallel-group, Noninferiority Trial. European Urology Open Science, 70. pp. 167-173. ISSN 2666-1691, DOI https://doi.org/10.1016/j.euros.2024.10.014.
Full text not available from this repository.Abstract
Guidelines recommend percutaneous nephrolithotomy (PCNL) for larger renal stones, but advances in flexible ureteroscopy (f-URS) with a tip-bendable suction ureteral access sheath (S-UAS) have prompted further investigation. Our multicenter, international, randomized controlled trial is investigating whether f-URS with S-UAS is noninferior to mini-PCNL (mPCNL) for renal stones of 2-3 cm. The primary objective is the immediate stone-free rate (SFR). Secondary outcomes include the 3-mo SFR, complication rates, surgical time, hospital stay, auxiliary procedures, and improvements in quality of life. A total of 720 patients from 12 urological centers will be randomized to either f-URS with S-UAS or PCNL. Statistical analyses will include intention-to-treat and per-protocol approaches, with specific methods for normally and non-normally distributed data. Subgroup analyses will focus on stone location and lithotripter types. The significance threshold will be set at p < 0.05. The aim of this trial is to generate high-level evidence regarding the noninferiority of fURS with S-UAS compared to mPCNL for medium-sized renal stones. The trial is registered on ClinicalTrials.gov as NCT06526390. (c) 2024 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY-NC-ND license.
| Item Type: | Article |
|---|---|
| Funders: | National Natural Science Foundation of China (NSFC) (82070721) ; (82270822), Fund for Enhancing Scientific Research of Guangzhou Medical University (GMUCR2024-01006) |
| Uncontrolled Keywords: | Urolithiasis; Retrograde intrarenal surgery; Ureteral access sheath; Percutaneous nephrolithotomy; Flexible urteroscopy; Tip bandable suction ureteral access sheath |
| Subjects: | R Medicine > R Medicine (General) |
| Divisions: | Universiti Malaya Medical Centre (UMMC) |
| Depositing User: | Ms. Juhaida Abd Rahim |
| Date Deposited: | 21 Feb 2025 02:03 |
| Last Modified: | 21 Feb 2025 02:03 |
| URI: | http://eprints.um.edu.my/id/eprint/47348 |
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