Clinical Trials Directory

Trials / Completed

CompletedNCT06689683

Fluoroscopy Activation Interval in SWL

Comparison of Two Different Fluoroscopy Activation Intervals in Shock Wave Lithotripsy: a Prospective Randomised Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
158 (actual)
Sponsor
Lütfi Kırdar City Hospital · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

Shock wave lithotripsy (SWL) is a noninvasive method widely used as the first step in treating stone disease. This study aimed to reduce radiation exposure to patients and practitioners during SWL sessions by extending the intervals of fluoroscopy controls. The main questions it aims to answer are: * Will radiation exposure be reduced? * Will the stone-free status be affected? The researchers will compare the fluoroscopic control intervals of 250 shocks and 500 shocks. Participants will: * Take to a maximum of 3 sessions. * Check once a week * Group 1 was fluoroscopically monitored every 250 shocks, and Group 2 was fluoroscopically monitored every 500 shocks

Detailed description

SWL works on the principle of focusing on the calculus using ultrasonography or fluoroscopy, transmitting high-energy shock waves from the lithotripter to the calculus and fragmenting it. Fluoroscopic focusing is a commonly used imaging technique that raises concerns about ionizing radiation exposure for patients, technologists, and physicians. Intermittent fluoroscopic monitoring during SWL is widely employed to adjust for patient movement, respiratory movement, and stone displacement within the kidney. However, there is no consensus on the optimal frequency of fluoroscopic monitoring in the literature. This study aims to seek to determine whether increasing the duration between fluoroscopic checks affects the success rate of SWL in achieving stone-free status while reducing radiation exposure to patients.

Conditions

Interventions

TypeNameDescription
DEVICEShock wave lithotripsySWL works on the principle of focusing on the calculus using fluoroscopy. There has yet to be a consensus on the optimal frequency of fluoroscopic monitoring in the literature.

Timeline

Start date
2020-07-27
Primary completion
2024-01-05
Completion
2024-01-05
First posted
2024-11-14
Last updated
2024-11-14

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06689683. Inclusion in this directory is not an endorsement.