Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT01922414

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Stones	Device: Laser Device: Ultrasonic	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Laser Patients will undergo Laser lithotripsy	Device: Laser Patients will undergo laser lithotripsy durin PNL
Active Comparator: Ultrasonic Patients will undergo ultrasonic lithotripsy	Device: Ultrasonic Patients will undergo ultrasonic lithotripsy during PNL

Arm

Intervention/Treatment

Active Comparator: Laser

Patients will undergo Laser lithotripsy

Device: Laser

Patients will undergo laser lithotripsy durin PNL

Active Comparator: Ultrasonic

Patients will undergo ultrasonic lithotripsy

Device: Ultrasonic

Patients will undergo ultrasonic lithotripsy during PNL

Outcome Measures

Primary Outcome Measures

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

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
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
Hospital stay [up to 7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)