Fluoroscopy Activation Interval in SWL

Not Applicable

Completed

• Conditions: Kidney Calculi

• Registration Number: NCT06689683
• Lead Sponsor: Lütfi Kırdar City Hospital

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.

Study Timeline

• Study Start: 2020-07-27
• Primary Completion: 2024-01-05
• Study Completion: 2024-01-05
• Status Verified: 2024-11
• Study First Submitted: 2024-11-09
• Study First Submitted QC: 2024-11-13
• Last Update Submitted: 2024-11-13
• Study First Posted: 2024-11-14
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
evaluate The effect of two different fluoroscopic activation intervals on the stone-free rate.	1 month after the end of treatment	Session 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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Health Science University Kartal Dr. Lütfi Kırdar City Hospital; 🇹🇷 İstanbul, Turkey