Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones

Study Overview
=================
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

Official Title
-----------------
Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones

Conditions
-----------------
Kidney Stones

Intervention / Treatment
-----------------
* Device: Laser
* Device: Ultrasonic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Complete staghorn stones (filling the renal pelvis and branching to 3 major calyces Age: 18-70 years Exclusion Criteria: Congenital renal anomalies such as horse shoe kidney. Contraindications to PNL such as bleeding tendency and uncontrolled hypertension. Associated pathological features requiring open intervention such as UPJO Partial staghorn stones (filling the renal pelvis and branching to 2 major calyces) Giant staghorn stone (very large staghorn stone that branch and re-branch in hugely dilated calyceal system)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laser<br>Patients will undergo Laser lithotripsy | Device: Laser<br>* Patients will undergo laser lithotripsy durin PNL<br>|
| Active Comparator: Ultrasonic<br>Patients will undergo ultrasonic lithotripsy | Device: Ultrasonic<br>* Patients will undergo ultrasonic lithotripsy during PNL<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone Free rate | Assessment of stone free rate after 3 months from treatment using NCCT | Patients will be followed for 3 months after the procedure | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Staghorn stones, Percutaneous nephrolithotomy, Laser, Randomized trial, Lithotripsy