Ensaio prospectivo, randomizado, duplo-cego: litotripsia a laser de hólmio com vs. sem MosesTM 2.0

Resumo original em inglês

O que aconteceu

To assess the effect of Moses™ 2.0 (Lumenis Be Ltd., Yokneam Illit, Israel; Boston Scientific, Marlborough, MA, USA) for lithotripsy of renal stones of 8-20 mm in diameter on operative time, surgeon workload, and retropulsion.

In our multicentre, randomised, double-blind clinical trial, patients were randomised 1:1 to standard or Moses 2.0 laser lithotripsy and stratified by stone size. Patients and surgeons were blinded to laser modality. Primary outcomes were total operative time as well as surgeon workload assessed by the National Aeronautics and Space Administration-Task Load Index (NASA-TLX). Secondary outcomes were stone retropulsion evaluated by blinded video review and postoperative clinical outcomes. Linear regression modelling was used for analysis.

O que encontraram

A total of 153 patients (79 Standard, 74 Moses 2.0) with similar clinical, stone, and operative characteristics were evaluated. There was no significant difference in operative times between the Standard and Moses 2.0 groups (P = 0.73). Moses 2.0 was associated with lower effort, frustration, mental, physical, and temporal workload, as well as higher rated overall performance compared to the standard laser. Video review demonstrated no difference in rates of retropulsion (P = 0.13). Complication rates (Standard: 13%; Moses 2.0: 10%) and stone-free rates (Standard: 51%; Moses: 2.0 55%) were comparable.

Por que isso importa

Our study evaluated the impact of Moses 2.0 technology on high-powered renal stone dusting, constituting the largest double-blind trial of its kind to date. There was insufficient evidence to suggest any difference in operative times or clinical outcomes when using Moses 2.0 compared to standard laser lithotripsy. Moses 2.0 was associated with reduced surgeon workload, which has implicit impact on surgeon wellness.

Resumo publicado sob licença CC BY. A tradução para o português ainda não chegou a este estudo.