Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization

NCT ID: NCT05413603

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-25
• Study Completion Date: 2023-05-30

Brief Summary

Epidemiological studies have shown a progressive increase in the incidence of pediatric urolithiasis over the past few decades.

Detailed Description

Pediatric stone disease is considered endemic in developing nations including Turkey, Pakistan, and eastern countries. The introduction of SWL by Chaussy et al. in the early 1980s revolutionized the management of upper urinary tract calculus disease.

Reports of successful SWL in children were first published in 1986; then several reports showed safety, and stone-free rates comparable with those of adults. For successful SWL, accurate localization of the shock waves is performed by ultrasound (US) or fluoroscope (FS) to fully focus the shock waves on the stone

Conditions

Stone, Kidney; Child, Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

fluoroscopic focus Shock wave lithotripsy

Shock wave lithotripsy, accurate localization of the shock waves is performed by the fluoroscope (FS) to fully focus the shock waves on the stone

Group Type: ACTIVE_COMPARATOR

ultrasonic focus Shock wave lithotripsy

Intervention Type: PROCEDURE

successful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone

fluoroscopic focus Shock wave lithotripsy

Intervention Type: PROCEDURE

successful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone

ultrasonic focus Shock wave lithotripsy

Shock wave lithotripsy, accurate localization of the shock waves is performed by the ultrasound (US), to fully focus the shock waves on the stone

Group Type: ACTIVE_COMPARATOR

ultrasonic focus Shock wave lithotripsy

Intervention Type: PROCEDURE

successful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone

fluoroscopic focus Shock wave lithotripsy

Intervention Type: PROCEDURE

successful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone

Interventions

ultrasonic focus Shock wave lithotripsy

successful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone

Intervention Type: PROCEDURE

fluoroscopic focus Shock wave lithotripsy

successful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Children (2-16) years of age with radiopaque renal pelvic stones less than 20 mm

Exclusion Criteria

1. Previous percutaneous nephrolithotripsy at the same side.

2. Previous renal exploration for stones at the same side.

3. Positive urinary culture.

4. Calyceal stones

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egymedicalpedia

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahmoud Moubarak, Resident

Role: PRINCIPAL_INVESTIGATOR

Urology department - faculty of medicine, South Valley university.

Locations

Urology department - faculty of medicine, South Valley university

Qina, , Egypt

Countries

Egypt

Other Identifiers

Mahmoud Moubarak

Identifier Type: -

Identifier Source: org_study_id