Fluoroscopy Activation Interval in SWL

NCT ID: NCT06689683

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-27
• Study Completion Date: 2024-01-05

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.

Conditions

Kidney Calculi

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

250 shocks

In our clinic, it is standard practice to perform a fluoroscopic check after every 250 shocks during the SWL session. Group 1 was fluoroscopically monitored every 250 shocks.

Group Type: ACTIVE_COMPARATOR

Shock wave lithotripsy

Intervention Type: DEVICE

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.

500 shocks

Group 2 was fluoroscopically monitored every 500 shocks.

Group Type: ACTIVE_COMPARATOR

Shock wave lithotripsy

Intervention Type: DEVICE

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.

Interventions

Shock wave lithotripsy

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lütfi Kırdar City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cengiz Canakcı, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Health Science University Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Canakci0001

Identifier Type: -

Identifier Source: org_study_id