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Laparoscopic Pyelolithotomy Versus Percutaneous Nephrolothotomy for Management of >3cm Renal Pelvis Stone

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ClinicalTrials.gov Identifier: NCT01637337
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):
Alireza Aminsharifi, Shiraz University of Medical Sciences

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
To compare the outcome of laparoscopic pyelolithotomy with percutaneous nephrolithotomy in patients with >3cm renal pelvis stone.

Condition or disease Intervention/treatment Phase
Renal Pelvis Stone >3cm Procedure: laparoscopic pyelolithotomy Procedure: percutaneous nephrolithotomy Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : January 2013
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: laparoscopic pyelolithotomy Procedure: laparoscopic pyelolithotomy
laparoscopy
Sham Comparator: percutaneous nephrolithotomy Procedure: percutaneous nephrolithotomy
percutaneous nephrolithotomy


Outcome Measures
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Primary Outcome Measures :
  1. Stone free rate [ Time Frame: at least 6 month after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with >3cm renal pelvis stone

Exclusion Criteria:

  • History of previous surgery on the target kidney
  • Active UTI
  • Coagulopathy
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637337


Locations
Iran, Islamic Republic of
Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of, 71344
Sponsors and Collaborators
Shiraz University of Medical Sciences
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Alireza Aminsharifi, Assistant Professor of Urology, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01637337     History of Changes
Other Study ID Numbers: 89-01-01-2391
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016