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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01637337
First Posted: July 11, 2012
Last Update Posted: April 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alireza Aminsharifi, Shiraz University of Medical Sciences
  Purpose
To compare the outcome of laparoscopic pyelolithotomy with percutaneous nephrolithotomy in patients with >3cm renal pelvis stone.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Alireza Aminsharifi, Shiraz University of Medical Sciences:

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

Enrollment: 60
Study Start Date: May 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: laparoscopic pyelolithotomy Procedure: laparoscopic pyelolithotomy
laparoscopy
Sham Comparator: percutaneous nephrolithotomy Procedure: percutaneous nephrolithotomy
percutaneous nephrolithotomy

  Eligibility

Information from the National Library of Medicine

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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
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

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 Submitted: July 3, 2012
First Posted: July 11, 2012
Last Update Posted: April 20, 2016
Last Verified: April 2016