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

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 ]


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 September 30, 2016

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