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Fluoroscopy Activation Interval in SWL

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06689683
Enrollment
158
Registered
2024-11-14
Start date
2020-07-27
Completion date
2024-01-05
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Calculi

Keywords

kidney stone, shock wave lithotripsy, radiation

Brief 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.

Interventions

SWL 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.

Sponsors

Lütfi Kırdar City Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* radiopaque renal pelvic stones smaller than 2 centimeters.

Exclusion criteria

* anatomical anomalies, coagulation disorders, non-opaque calculi, active urinary infection and distal obstruction

Design outcomes

Primary

MeasureTime frameDescription
evaluate The effect of two different fluoroscopic activation intervals on the stone-free rate.1 month after the end of treatmentSession intervals were determined as one week, and patients with residues visible on the KUB radiography before the session were included in the new session. At the end of the treatment, direct radiography and ultrasound of the urinary system was performed at the end of the first month. Patients with stones larger than 4 mm were considered to have had an unsuccessful treatment.

Secondary

MeasureTime frameDescription
Secondary endpoints were total fluoroscopy time and complications.From registration until the 1st month after the end of treatment.The total fluoroscopy time (seconds) during treatment will be calculated.
Secondary endpoints were complications.From registration until the 1st month after the end of treatment.Complications occurring from the beginning of treatment to the end of treatment, such as additional intervention, pyelonephritis, steinstrausse.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026