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Comparing Pneumatic Versus Ultra-sonic Percutaneous Nephrolithotomy in Large Kidney Stones

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ClinicalTrials.gov Identifier: NCT02751281
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Collaborator:
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
Hamidreza Shemshaki, Isfahan University of Medical Sciences

Brief Summary:
The purpose of this study is to determine which type of percutaneous nephrolithotomy is better in large kidney stones

Condition or disease Intervention/treatment Phase
Kidney Stone Procedure: Pneumatic percutaneous nephrolithotomy Procedure: Ultra-sonic percutaneous nephrolithotomy Phase 2

Detailed Description:
While there are several retrospective studies evaluating the efficacy of different lithotripter in percutaneous nephrolithotomy, there are few prospective studies in this regard. This study was designed to compare the efficacy and safety of Ultrasonic versus pneumatic percutaneous nephrolithotomy in treatment of large kidney stones.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Pneumatic Versus Ultra-sonic Percutaneous Nephrolithotomy in Large Kidney Stones
Study Start Date : December 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Arm Intervention/treatment
Active Comparator: pneumatic percutaneous nephrolithotomy
pneumatic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone
Procedure: Pneumatic percutaneous nephrolithotomy
Pneumatic percutaneous nephrolithotomy is type of surgery that we use pneumatic lithotripter to treat kidney stone

Active Comparator: Ultra-sonic percutaneous nephrolithotomy
Ultra-sonic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone
Procedure: Ultra-sonic percutaneous nephrolithotomy
Ultra-sonic percutaneous nephrolithotomy is type of surgery that we use ultra-sonic lithotripter to treat kidney stone




Primary Outcome Measures :
  1. stone free rate [ Time Frame: 3 months after surgery ]

Secondary Outcome Measures :
  1. hemoglobin loss [ Time Frame: 2 days after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- patients with >2cm kidney stone

Exclusion Criteria:

  • Pregnant women
  • patients with coagulopathies
  • patients with scattered stones who needed several accesses

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): NCT02751281


Sponsors and Collaborators
Isfahan University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Investigators
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Study Chair: Nasser Simforoosh, Prof Shahid Beheshty University of Medical Sciences

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Responsible Party: Hamidreza Shemshaki, Dr, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02751281     History of Changes
Other Study ID Numbers: ASD-100
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hamidreza Shemshaki, Isfahan University of Medical Sciences:
pneumatic
ultra-sonic
percutaneous nephrolithotomy

Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical