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

Primary Purpose

Kidney Stone

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pneumatic percutaneous nephrolithotomy
Ultra-sonic percutaneous nephrolithotomy
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone focused on measuring pneumatic, ultra-sonic, percutaneous nephrolithotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- patients with >2cm kidney stone

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    pneumatic percutaneous nephrolithotomy

    Ultra-sonic percutaneous nephrolithotomy

    Arm Description

    pneumatic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone

    Ultra-sonic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone

    Outcomes

    Primary Outcome Measures

    stone free rate

    Secondary Outcome Measures

    hemoglobin loss

    Full Information

    First Posted
    April 18, 2016
    Last Updated
    April 21, 2016
    Sponsor
    Isfahan University of Medical Sciences
    Collaborators
    Shahid Beheshti University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02751281
    Brief Title
    Comparing Pneumatic Versus Ultra-sonic Percutaneous Nephrolithotomy in Large Kidney Stones
    Official Title
    Comparing Pneumatic Versus Ultra-sonic Percutaneous Nephrolithotomy in Large Kidney Stones
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Isfahan University of Medical Sciences
    Collaborators
    Shahid Beheshti University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Kidney Stone
    Keywords
    pneumatic, ultra-sonic, percutaneous nephrolithotomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pneumatic percutaneous nephrolithotomy
    Arm Type
    Active Comparator
    Arm Description
    pneumatic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone
    Arm Title
    Ultra-sonic percutaneous nephrolithotomy
    Arm Type
    Active Comparator
    Arm Description
    Ultra-sonic percutaneous nephrolithotomy is type of surgery in treatment of kidney stone
    Intervention Type
    Procedure
    Intervention Name(s)
    Pneumatic percutaneous nephrolithotomy
    Intervention Description
    Pneumatic percutaneous nephrolithotomy is type of surgery that we use pneumatic lithotripter to treat kidney stone
    Intervention Type
    Procedure
    Intervention Name(s)
    Ultra-sonic percutaneous nephrolithotomy
    Intervention Description
    Ultra-sonic percutaneous nephrolithotomy is type of surgery that we use ultra-sonic lithotripter to treat kidney stone
    Primary Outcome Measure Information:
    Title
    stone free rate
    Time Frame
    3 months after surgery
    Secondary Outcome Measure Information:
    Title
    hemoglobin loss
    Time Frame
    2 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - patients with >2cm kidney stone Exclusion Criteria: Pregnant women patients with coagulopathies patients with scattered stones who needed several accesses
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nasser Simforoosh, Prof
    Organizational Affiliation
    Shahid Beheshty University of Medical Sciences
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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