Evaluation of a novel fascial dilator modified with scale marker in percutaneous nephrolithotomy for reducing the x-ray exposure: A randomized clinical study

摘要

Objective: To evaluate the role of the fascial dilators modified with a scale marker in reducing fluoroscopy time during percutaneous nephrolithotomy (PCNL). Method: In a randomized clinical trial, eligible 100 consecutive patients anticipated to undergo single-tract PCNL were randomly assigned into two groups by the closed envelope method, to compare the efficacy and safety of the modified scale fascial dilator (group 1, n=50) and traditional nonscale fascial dilator (group 2, n=50) with respect to the X-ray exposure duration as well as the outcome of PCNL. Results: There was no significant difference between group 1 and group 2 regarding to the initial successful access rate (100% v 96%), operative time (79.4 v 83.7 minutes), the initial stone-free rate (82% v 81.3%), complications (24% v 20%), and bleeding required blood transfusion (4% v 6%) (all p>0.05). The mean operative duration and fluoroscopic time for tract dilation in group 1 and group 2 were 164.4±19 seconds v 168.3±14 seconds, and 3.2±0.9 seconds v 22.2±4.6 seconds, (p=0.250 and p<0.001), respectively. Conclusions: Compared to the use of nonscaled dilators, using the scaled fascial dilators for a percutaneous access in PCNL was found to be associated with less radiation hazards along with similar stone-free rate and complications.