Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones

Not Applicable

Completed

• Conditions: Kidney Stones
• Interventions: Device: Ultrasonic; Device: Laser

• Registration Number: NCT01922414
• Lead Sponsor: Mansoura University

Brief Summary

This study will be conducted to compare the results of Laser and ultrasonic lithotripsy in disintegration of staghorn stones during percutaneous nephrolithotomy.

Detailed Description

Patients with complete staghorn stones who are eligible to percutaneous nephrolithotomy (PNL) will be randomized between two groups.

Group 1: will undergo Laser lithotripsy during PNL Group 2: will undergo ultrasonic lithotripsy during PNL

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-08-01
• Study First Submitted QC: 2013-08-12
• Study First Posted: 2013-08-14
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Complete staghorn stones (filling the renal pelvis and branching to 3 major calyces
2. Age: 18-70 years

Exclusion Criteria

1. Congenital renal anomalies such as horse shoe kidney.
2. Contraindications to PNL such as bleeding tendency and uncontrolled hypertension.
3. Associated pathological features requiring open intervention such as UPJO
4. Partial staghorn stones (filling the renal pelvis and branching to 2 major calyces)
5. Giant staghorn stone (very large staghorn stone that branch and re-branch in hugely dilated calyceal system)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasonic	Ultrasonic	Patients will undergo ultrasonic lithotripsy
Laser	Laser	Patients will undergo Laser lithotripsy

Primary Outcome Measures

Name	Time	Method
Stone Free rate	Patients will be followed for 3 months after the procedure	Assessment of stone free rate after 3 months from treatment using NCCT

Secondary Outcome Measures

Name	Time	Method
Assessment of the safety of each technique	From the start of the operation till 3 months after discharge from the hospital	Measurement of complication rates, classifications of the severity of complications
Hospital stay	up to 7 days
Operative time	An expected average of 3 hours	Measurement of the time from start of ureteral catheter fixation till the fixation of the nephrostomy tube

Trial Locations

Locations (1)

Urology and Nephrology Center; 🇪🇬 Mansoura, Dakhlia, Egypt