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Clinical Trials/NCT01922414
NCT01922414CompletedNot Applicable

Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones

Mansoura University1 site in 1 country70 target enrollmentStarted: August 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
1
Primary Endpoint
Stone Free rate

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Laser

Active Comparator

Patients will undergo Laser lithotripsy

Intervention: Laser (Device)

Ultrasonic

Active Comparator

Patients will undergo ultrasonic lithotripsy

Intervention: Ultrasonic (Device)

Outcomes

Primary Outcomes

Stone Free rate

Time Frame: Patients will be followed for 3 months after the procedure

Assessment of stone free rate after 3 months from treatment using NCCT

Secondary Outcomes

  • Operative time(An expected average of 3 hours)
  • Assessment of the safety of each technique(From the start of the operation till 3 months after discharge from the hospital)
  • Hospital stay(up to 7 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed R. EL-Nahas

Assistant Professor of Urology

Mansoura University

Study Sites (1)

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