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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alireza Aminsharifi, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01637337
First received: July 3, 2012
Last updated: April 19, 2016
Last verified: April 2016
  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 ]

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

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: July 3, 2012
Last Updated: April 19, 2016
Health Authority: Iran: Ministry of Health

ClinicalTrials.gov processed this record on July 25, 2016