Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones

August 10, 2015 updated by: Ahmed R. EL-Nahas, Mansoura University
This study will be conducted to compare the results of Laser and ultrasonic lithotripsy in disintegration of staghorn stones during percutaneous nephrolithotomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakhlia
      • Mansoura, Dakhlia, Egypt, 35516
        • Urology and nephrology center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: From the start of the operation till 3 months after discharge from the hospital
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
Time Frame: An expected average of 3 hours
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
Time Frame: up to 7 days
up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Ahmed R. EL-Nahas, MD, Faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 1, 2013

First Submitted That Met QC Criteria

August 12, 2013

First Posted (Estimate)

August 14, 2013

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 10, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Staghorn Laser
  • Staghorn Laser vs US (Other Identifier: Urology and Nephrology Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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