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Completed

NCT Number: NCT01922414

Laser Versus Ultrasonic Lithotripsy in Percutaneous Nephrolithotomy for Staghorn Stones

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology and Nephrology Center

Al Mansurah, Dakhlia, 35516, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

laser

Device

Patients will undergo laser lithotripsy durin PNL

Ultrasonic

Device

Patients will undergo ultrasonic lithotripsy during PNL

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. Hospital stay

    Time frame: up to 7 days

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 14, 2013
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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