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Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial
Introduction: Currently, there are multiple intracorporeal lithotripters available for use in percutaneous nephrolithotomy (PCNL). This study aimed to evaluate the efficiency of two novel lithotripters: Trilogy and ShockPulse-SE. Materials and Methods: This is a prospective multi-institutional rando...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Mary Ann Liebert, Inc., publishers
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8558064/ https://www.ncbi.nlm.nih.gov/pubmed/33843245 http://dx.doi.org/10.1089/end.2020.1097 |
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author | Large, Tim Nottingham, Charles Brinkman, Ethan Agarwal, Deepak Ferrero, Andrea Sourial, Michael Stern, Karen Rivera, Marcelino Knudsen, Bodo Humphreys, Mitchel Krambeck, Amy |
author_facet | Large, Tim Nottingham, Charles Brinkman, Ethan Agarwal, Deepak Ferrero, Andrea Sourial, Michael Stern, Karen Rivera, Marcelino Knudsen, Bodo Humphreys, Mitchel Krambeck, Amy |
author_sort | Large, Tim |
collection | PubMed |
description | Introduction: Currently, there are multiple intracorporeal lithotripters available for use in percutaneous nephrolithotomy (PCNL). This study aimed to evaluate the efficiency of two novel lithotripters: Trilogy and ShockPulse-SE. Materials and Methods: This is a prospective multi-institutional randomized trial comparing outcomes of PCNL using two novel lithotripters between February 2019 and June 2020. The study assessed objective measures of stone clearance time, stone clearance rate, device malfunction, stone-free rates, and complications. Device assessment was provided through immediate postoperative survey by primary surgeons. Results: There were 100 standard PCNLs completed using either a Trilogy or ShockPulse-SE lithotrite. Using quantitative Stone Analysis Software to estimate stone volume, the mean stone volume was calculated at 4.18 ± 4.79 and 3.86 ± 3.43 cm(3) for the Trilogy and ShockPulse-SE groups, respectively. Stone clearance rates were found to be 1.22 ± 1.67 and 0.77 ± 0.68 cm(3)/min for Trilogy vs ShockPulse-SE (p = 0.0542). When comparing Trilogy to ShockPulse-SE in a multivariate analysis, total operative room time (104.4 ± 48.2 minutes vs 121.1 ± 59.2 minutes p = 0.126), rates of secondary procedures (17.65% vs 40.81%, p = 0.005), and device malfunctions (1.96% vs 34.69%, p < 0.001) were less, respectively. There was no difference in final stone-free rates between devices. Conclusion: Both the Trilogy and ShockPulse-SE lithotripters are highly efficient at removing large renal stones. In this study, we noted differences between the two devices including fewer device malfunctions when Trilogy device was utilized. Clinical Trial ID number: NCT03959683 |
format | Online Article Text |
id | pubmed-8558064 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Mary Ann Liebert, Inc., publishers |
record_format | MEDLINE/PubMed |
spelling | pubmed-85580642021-11-01 Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial Large, Tim Nottingham, Charles Brinkman, Ethan Agarwal, Deepak Ferrero, Andrea Sourial, Michael Stern, Karen Rivera, Marcelino Knudsen, Bodo Humphreys, Mitchel Krambeck, Amy J Endourol Ureteroscopy and Percutaneous Procedures Introduction: Currently, there are multiple intracorporeal lithotripters available for use in percutaneous nephrolithotomy (PCNL). This study aimed to evaluate the efficiency of two novel lithotripters: Trilogy and ShockPulse-SE. Materials and Methods: This is a prospective multi-institutional randomized trial comparing outcomes of PCNL using two novel lithotripters between February 2019 and June 2020. The study assessed objective measures of stone clearance time, stone clearance rate, device malfunction, stone-free rates, and complications. Device assessment was provided through immediate postoperative survey by primary surgeons. Results: There were 100 standard PCNLs completed using either a Trilogy or ShockPulse-SE lithotrite. Using quantitative Stone Analysis Software to estimate stone volume, the mean stone volume was calculated at 4.18 ± 4.79 and 3.86 ± 3.43 cm(3) for the Trilogy and ShockPulse-SE groups, respectively. Stone clearance rates were found to be 1.22 ± 1.67 and 0.77 ± 0.68 cm(3)/min for Trilogy vs ShockPulse-SE (p = 0.0542). When comparing Trilogy to ShockPulse-SE in a multivariate analysis, total operative room time (104.4 ± 48.2 minutes vs 121.1 ± 59.2 minutes p = 0.126), rates of secondary procedures (17.65% vs 40.81%, p = 0.005), and device malfunctions (1.96% vs 34.69%, p < 0.001) were less, respectively. There was no difference in final stone-free rates between devices. Conclusion: Both the Trilogy and ShockPulse-SE lithotripters are highly efficient at removing large renal stones. In this study, we noted differences between the two devices including fewer device malfunctions when Trilogy device was utilized. Clinical Trial ID number: NCT03959683 Mary Ann Liebert, Inc., publishers 2021-09-01 2021-09-14 /pmc/articles/PMC8558064/ /pubmed/33843245 http://dx.doi.org/10.1089/end.2020.1097 Text en © Tim Large et al., 2021; Published by Mary Ann Liebert, Inc. https://creativecommons.org/licenses/by/4.0/This Open Access article is distributed under the terms of the Creative Commons License [CC-BY] (http://creativecommons.org/licenses/by/4.0 (https://creativecommons.org/licenses/by/4.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. |
spellingShingle | Ureteroscopy and Percutaneous Procedures Large, Tim Nottingham, Charles Brinkman, Ethan Agarwal, Deepak Ferrero, Andrea Sourial, Michael Stern, Karen Rivera, Marcelino Knudsen, Bodo Humphreys, Mitchel Krambeck, Amy Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial |
title | Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial |
title_full | Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial |
title_fullStr | Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial |
title_full_unstemmed | Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial |
title_short | Multi-Institutional Prospective Randomized Control Trial of Novel Intracorporeal Lithotripters: ShockPulse-SE vs Trilogy Trial |
title_sort | multi-institutional prospective randomized control trial of novel intracorporeal lithotripters: shockpulse-se vs trilogy trial |
topic | Ureteroscopy and Percutaneous Procedures |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8558064/ https://www.ncbi.nlm.nih.gov/pubmed/33843245 http://dx.doi.org/10.1089/end.2020.1097 |
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