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

This study is currently recruiting participants.
Verified July 2012 by Shiraz University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Alireza Aminsharifi, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01637337
First received: July 3, 2012
Last updated: July 13, 2012
Last verified: July 2012
History of Changes
  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: Open Label
Primary Purpose: Treatment

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

Primary Outcome Measures:
  • Stone free rate [ Time Frame: at least 6 month after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2012
Estimated 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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637337

Locations
Iran, Islamic Republic of
Shiraz University of Medical Sciences Recruiting
Shiraz, Fars, Iran, Islamic Republic of, 71344
Contact: Alireza Aminsharifi, MD     9177000656 ext 0098     aminsharifi_ar@yahoo.com    
Principal Investigator: Alireza Aminsharifi, MD            
Sponsors and Collaborators
Shiraz University of Medical Sciences
  More Information

No publications provided

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
Study First Received: July 3, 2012
Last Updated: July 13, 2012
Health Authority: Iran: Ministry of Health

ClinicalTrials.gov processed this record on May 21, 2013