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<p>To observe the efficacy and safety of retrograde intrarenal surgery (RIRS) combined with a flexible vacuum-assisted ureteral access sheath (FV–UAS) in patients with large renal stones (LRS). A total of 149 patients with LRS were prospectively randomized into two groups: 75 in the FV–UAS group and 74 in the minimally invasive percutaneous nephrolithotomy (MPCNL) group. The primary outcome was the stone-free rates (SFRs) on the first postoperative day. Secondary endpoints included the total SFRs 1 month postoperatively, lithotripsy time, hemoglobin reduction, length of postoperative hospital stay, quality of life (QoL) score improvement, incidence of ureteral stricture at 3 months postoperatively, and any surgery-related complications. Patient demographics and preoperative clinical characteristics showed no apparent difference between the two groups (all <i>P</i> &gt; 0.05). Postoperative data revealed a significantly longer lithotripsy time in the FV–UAS group than the MPCNL group (113.1 vs. 82.5&#xa0;min, <i>P</i> &lt; 0.001). The mean decrease in hemoglobin was significantly lower in the FV–UAS group than in the MPCNL group (8.2 vs. 17.7&#xa0;g/L, <i>P</i> &lt; 0.001). Similarly, the average hospital stay was shorter in the FV–UAS group than the MPCNL group (1.7 vs. 5.1 d, <i>P</i> &lt; 0.001). Meanwhile, SFRs on the first postoperative day and 1 month postoperatively were statistically similar between the two groups (<i>P</i> &gt; 0.05). QoL improvement was significantly higher in the FV–UAS group than in the MPCNL group (33.4 vs. 26.9, <i>P</i> &lt; 0.001). The difference in ureteral stricture at 3 months postoperatively was not statistically significant (<i>P</i> &gt; 0.05). Notably, the overall rate of postoperative complications was markedly lower in the FV–UAS group than in the MPCNL group (<i>P</i> &lt; 0.05). Our study showed the safety and feasibility of applying RIRS combined with FV–UAS for LRS treatment, providing advantages such as high SFRs, minimal trauma, fast recovery, and low incidence of postoperative complications. It can be used as a clinical treatment alternative for LRS. The protocol for this study has been accepted by the Chinese Clinical Trial Registry (Ethics approval number: ChiCTR2200056402; Date of registration: 02-05-2022).</p>

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RIRS with flexible vacuum-assisted ureteral access sheath for large renal stones: a prospective randomized controlled study

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  • 发表日期：

    2025年11月28日

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  • Ye-fei Ding,
  • Tao Lin,
  • Yan Cheng,
  • Guan-li Huang,
  • Yun-bo Ma

摘要

To observe the efficacy and safety of retrograde intrarenal surgery (RIRS) combined with a flexible vacuum-assisted ureteral access sheath (FV–UAS) in patients with large renal stones (LRS). A total of 149 patients with LRS were prospectively randomized into two groups: 75 in the FV–UAS group and 74 in the minimally invasive percutaneous nephrolithotomy (MPCNL) group. The primary outcome was the stone-free rates (SFRs) on the first postoperative day. Secondary endpoints included the total SFRs 1 month postoperatively, lithotripsy time, hemoglobin reduction, length of postoperative hospital stay, quality of life (QoL) score improvement, incidence of ureteral stricture at 3 months postoperatively, and any surgery-related complications. Patient demographics and preoperative clinical characteristics showed no apparent difference between the two groups (all P > 0.05). Postoperative data revealed a significantly longer lithotripsy time in the FV–UAS group than the MPCNL group (113.1 vs. 82.5 min, P < 0.001). The mean decrease in hemoglobin was significantly lower in the FV–UAS group than in the MPCNL group (8.2 vs. 17.7 g/L, P < 0.001). Similarly, the average hospital stay was shorter in the FV–UAS group than the MPCNL group (1.7 vs. 5.1 d, P < 0.001). Meanwhile, SFRs on the first postoperative day and 1 month postoperatively were statistically similar between the two groups (P > 0.05). QoL improvement was significantly higher in the FV–UAS group than in the MPCNL group (33.4 vs. 26.9, P < 0.001). The difference in ureteral stricture at 3 months postoperatively was not statistically significant (P > 0.05). Notably, the overall rate of postoperative complications was markedly lower in the FV–UAS group than in the MPCNL group (P < 0.05). Our study showed the safety and feasibility of applying RIRS combined with FV–UAS for LRS treatment, providing advantages such as high SFRs, minimal trauma, fast recovery, and low incidence of postoperative complications. It can be used as a clinical treatment alternative for LRS. The protocol for this study has been accepted by the Chinese Clinical Trial Registry (Ethics approval number: ChiCTR2200056402; Date of registration: 02-05-2022).