Dataset Information

Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study.

ABSTRACT:

Background

Retrograde intrarenal surgery (RIRS) is the main treatments for upper urinary tract stones. The Ureteral Access Sheath (UAS) serves as a supplementary tool, facilitating direct kidney access during RIRS. High quality of evidence comparing tip bendable suction ureteral access sheath (S-UAS) with traditional UAS in RIRS for the treatment of renal and ureteral stones is lacking. The purpose of the study is to compare the efficacy and safety of S-UAS with traditional UAS in RIRS for the treatment of renal or ureteral stones ≤30 mm.

Methods

An international, multicenter, and superiority randomized controlled trial included 320 intention-to-treat patients across 8 medical centers in China, the Philippines, Malaysia and Turkey from August 2023 to February 2024. The inclusion criteria were patients ≥18 years old with renal or ureteral stones ≤30 mm. RIRS was performed using either S-UAS or traditional UAS. The primary outcome was the immediately stone-free rate (SFR). Secondary outcomes included SFR 3 months after operation, operating time, hospital stay, auxiliary procedures, complications (using the Clavien-Dindo grading system), and improvement in the Quality of Life (QoL) score. Differences between proportions [risk difference (RD)]/means [mean difference (MD)] and 95% confidence intervals (CI) were presented. This study is registered at ClinicalTrials.gov: NCT05952635.

Findings

The S-UAS group demonstrated a significantly higher immediately SFR (81.3% versus 49.4%; RD 31.9%; 95% CI 22.5%-41.7%; p = 0.004) compared to the traditional UAS group, as determined by the one-side superiority test. Additionally, the S-UAS group exhibited a higher SFR at 3 months post-operation (87.5% versus 70.0%; RD 17.5%; 95% CI 8.7%-26.3%; p < 0.001), lower postoperative fever rate (RD -11.9%; 95% CI -18.7% to -4.9%; p < 0.001), reduced use of stone baskets (RD -70.6%; 95% CI -77.8% to -63.5%; p < 0.001), and better QoL improvement (MD 7.25; 95% CI 2.21-12.29; p = 0.005). No statistically significant differences were observed in operation time, hospital stay, or the need for second-stage RIRS.

Interpretation

In RIRS for upper urinary tract stones ≤30 mm, S-UAS exhibited superior performance compared to traditional UAS, demonstrating higher SFR, reduced postoperative fever rate, and improved QoL outcomes. S-UAS emerges as a prudent and advantageous alternative to traditional UAS for RIRS.

Funding

National Natural Science Foundation of China and Guangdong Province, and Zhejiang Medicine and Health Program.

SUBMITTER: Zhu W

PROVIDER: S-EPMC11277316 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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Publications

Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study.

Zhu Wei W Liu Shusheng S Cao Jianwei J Wang Hao H Liang Hui H Jiang Kehua K Cui Yu Y Chai Chu Ann CA Sahinler Emre Burak EB Aquino Albert A Mazzon Giorgio G Zhong Wen W Zhao Zhijian Z Zhang Lin L Ding Jie J Wang Qing Q Wang Yizhou Y Chen Kelven Weijing KW Liu Yongda Y Choong Simon S Sarica Kemal K Zeng Guohua G

EClinicalMedicine 20240705

<h4>Background</h4>Retrograde intrarenal surgery (RIRS) is the main treatments for upper urinary tract stones. The Ureteral Access Sheath (UAS) serves as a supplementary tool, facilitating direct kidney access during RIRS. High quality of evidence comparing tip bendable suction ureteral access sheath (S-UAS) with traditional UAS in RIRS for the treatment of renal and ureteral stones is lacking. The purpose of the study is to compare the efficacy and safety of S-UAS with traditional UAS in RIRS f ...[more]

PMID: 39070176

Similar Datasets

Project description:BackgroundRetrograde intrarenal surgery (RIRS) is widely performed for renal stones. Theoretically, removing renal stones could prevent the deterioration of renal function. However, two studies reported that not all patients would see an increase in renal function after RIRS. The aim of our study was to evaluate the change of renal function of the operative site, and to identify predictors of improvement or deterioration of renal function after RIRS.MethodsWe retrospectively reviewed renal stones patients who received RIRS and single-photon emission computed tomography (SPECT) before and after surgery. Improved renal function was defined as the change of glomerular filtration rate (GFR) >10% postoperatively, and that <-10% was regarded as deteriorated renal function. Logistic and least absolute shrinkage and selection operator regression analyses were used to identify predictors for the improvement or deterioration of renal function, and predictive nomogram models were built.ResultsA total of 120 renal stone patients were included. Twenty-one (17.5%), 79 (65.8%) and 20 (16.7%) patients had improved, stable and deteriorated renal function of operative site after surgery, respectively. Lower alkaline phosphatase, lower low-density lipoprotein, lower GFR of the operative site, thicker renal parenchyma, higher serum creatinine, and extracorporeal shock wave lithotripsy (SWL) history were associated with the improved renal function. The predictive accuracy of the model for the improved renal function was 0.800. Additionally, older age, longer flexible ureteroscopic time, thinner renal parenchyma and existence of ureteral stones were risk factors for deteriorated renal function. The predictive accuracy of the model for the deteriorated renal function was 0.725.ConclusionsThe renal function of most renal stone patients did not decrease after RIRS. For patients with potential deterioration of renal function postoperatively, urologists could shorten flexible ureteroscopic time to prevent the occurrence of this outcome.

Project description:Retrograde intrarenal surgery (RIRS) is accepted as a primary modality for the management of renal stones up to 2 cm. The limitations of RIRS in larger volume stones include limited visualization due to the snow-globe effect and persistence of fragments that cannot be removed. We describe a new, simple, cost-effective modification that can be attached to any flexible ureteroscope which allows simultaneous/alternating suction and aspiration during/after laser lithotripsy using the scope as a conduit to remove the fragments or dust from the pelvicalyceal system called direct in-scope suction (DISS) technique. Between September 2020 and September 2021, 30 patients with kidney stones underwent RIRS with the DISS technique. They were compared with 28 patients who underwent RIRS with a 11Fr/13Fr suction ureteral access sheaths (SUASs) in the same period. RIRS and laser lithotripsy were carried out traditionally with a Holmium laser for the SUAS group or a thulium fiber laser for the DISS group. There was no difference in age, gender, and history of renal lithiasis between the two groups. Ten (40%) patients had multiple stones in the DISS groups, whilst there were no patients with multiple stones in the SUAS group. Median stone size was significantly higher in the DISS group [22.0 (18.0-28.8) vs. 13.0 (11.8-15.0) millimeters, p < 0.001]. Median surgical time was significantly longer in the DISS group [80.0 (60.0-100) minutes] as compared to the SUAS group [47.5 (41.5-60.3) minutes, p < 0.001]. Hospital stay was significantly shorter in the DISS group [1.00 (0.667-1.00) vs. 1.00 (1.00-2.00) days, p = 0.02]. Postoperative complications were minor, and there was no significant difference between the two groups. The incidence of residual fragments did not significantly differ between the two groups [10 (33.3%) in the DISS group vs. 10 (35.7%) in the SUAS group, p = 0.99] but 10 (33.3%) patients required a further RIRS for residual fragments in the DISS group, whilst only one (3.6%) patient in the SUAS group required a subsequent shock wave lithotripsy treatment. Our audit study highlighted that RIRS with DISS technique was feasible with an acceptable rate of retreatment as compared to RIRS with SUAS.

Dataset Information

Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study.

Background

Methods

Findings

Interpretation

Funding

Publications

Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study.

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