Fluoroscopy Activation Interval in SWL

NCT06689683 | Completed

• 1 other identifier: Canakci0001
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Calculi

Keywords

kidney stone; shock wave lithotripsy; radiation

Outcome Measures

Primary Outcomes (1)

• evaluate The effect of two different fluoroscopic activation intervals on the stone-free rate.

  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.

  1 month after the end of treatment

Secondary Outcomes (2)

• Secondary endpoints were total fluoroscopy time and complications.

  From registration until the 1st month after the end of treatment.

• Secondary endpoints were complications.

  From registration until the 1st month after the end of treatment.

Study Arms (2)

250 shocks

ACTIVE COMPARATOR

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.

Device: Shock wave lithotripsy

500 shocks

ACTIVE COMPARATOR

Group 2 was fluoroscopically monitored every 500 shocks.

Device: Shock wave lithotripsy

Interventions

Shock wave lithotripsy 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.

250 shocks; 500 shocks

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• radiopaque renal pelvic stones smaller than 2 centimeters.

You may not qualify if:

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

Sponsors & Collaborators

• Lütfi Kırdar City Hospital: lead

Study Sites (1)

Health Science University Kartal Dr. Lütfi Kırdar City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 14, 2024
• Study Start: July 27, 2020
• Primary Completion: January 5, 2024
• Study Completion: January 5, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)